title: Web-based care management in patients with poorly controlled diabetes. Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control Dulce Wireless Tijuana: A Randomized Control Trial Evaluating the Impact of Project Dulce and Short-Term Mobile Technology on Glycemic Control in a Family Medicine Clinic in Northern Mexico A Community-Based, Culturally Tailored Behavioral Intervention for Korean Americans With Type 2 Diabetes Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes Financial Incentives for Home-Based Health Monitoring: A Randomized Controlled Trial Case management for patients with poorly controlled diabetes: a randomized trial. Going Mobile With Diabetes Support: A Randomized Study of a Text Message–Based Personalized Behavioral Intervention for Type 2 Diabetes Self-Care Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice Results of the Northern Manhattan Diabetes Community Outreach Project: A Randomized Trial Studying a Community Health Worker Intervention to Improve Diabetes Care in Hispanic Adults Online disease management of diabetes: Engaging and Motivating Patients Online With Enhanced Resources-Diabetes (EMPOWER-D), a randomized controlled trial Effects of Self-Management Support on Structure, Process, and Outcomes Among Vulnerable Patients With Diabetes Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial Glucose control and vascular complications in veterans with type 2 diabetes. Peer-Led Diabetes Education Programs in High-Risk Mexican Americans Improve Glycemic Control Compared With Standard Approaches Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial Follow-up of glycemic control and cardiovascular outcomes in type 2 diabetes. Effect of a community-based diabetes self-management empowerment program on mental health-related quality of life: a causal mediation analysis from a randomized controlled trial Nurse–Community Health Worker Team Improves Diabetes Care in American Samoa Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement And Coaching for Health (PEACH) pragmatic cluster randomised controlled trial Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial. Impact of Peer Health Coaching on Glycemic Control in Low-Income Patients With Diabetes: A Randomized Controlled Trial Psychological family intervention for poorly controlled type 2 diabetes. Pharmacist collaborative management of poorly controlled diabetes mellitus: a randomized controlled trial. Nurse-Led Behavioral Management of Diabetes and Hypertension in Community Practices: A Randomized Trial Caring for Poorly Controlled Diabetes Mellitus: A Randomized Pharmacist Intervention Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study Evaluation of a behavior support intervention for patients with poorly controlled diabetes. Medical Clinics Versus Usual Care for Patients With Both Diabetes and Hypertension Peer Mentoring and Financial Incentives to Improve Glucose Control in African American Veterans A prospective randomized controlled study of a virtual clinic integrating primary and specialist care for patients with Type 2 diabetes mellitus. Diabetes Control With Reciprocal Peer Support Versus Nurse Care Management Evaluation of a nurse-care management system to improve outcomes in patients with complicated diabetes. Multidisciplinary approach to patients with poorly controlled type 2 diabetes mellitus: a prospective, randomized study A structured self-monitoring of blood glucose approach in type 2 diabetes encourages more frequent, intensive, and effective physician interventions: results from the STeP study. Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED) study. Effectiveness of a Supportive Telephone Counseling Intervention in Type 2 Diabetes Patients: Randomized Controlled Study Closing the gap: effect of diabetes case management on glycemic control among low-income ethnic minority populations: the California Medi-Cal type 2 diabetes study. A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes. Telephone peer-delivered intervention for diabetes motivation and support: the telecare exploratory RCT. Intensive Glycemic Control and the Prevention of Cardiovascular Events: Implications of the ACCORD, ADVANCE, and VA Diabetes Trials
abstract: OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a  diabetes education class  and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P < 0.05 ) when compared with education and usual care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P < 0.05 ) . A larger number of website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P < 0.02 ) . Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P < 0.01 ) . HDL cholesterol rose and triglycerides fell in the web-based group ( P < 0.05 ) . CONCLUSIONS Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year Abstract Background : The global epidemic of diabetes calls for innovative interventions . This study evaluated the effectiveness of the Project Dulce model , with and without wireless technology , on glycemic control and other clinical and self-reported outcomes in patients with poorly controlled type 2 diabetes in Mexico . Subjects and Methods : Adults with type 2 diabetes and a glycated hemoglobin A1c ( HbA1c ) level of ≥8 % were recruited from Family Medical Unit # 27 of the Instituto Mexicano del Seguro Social ( IMSS ) in Tijuana , México , and r and omly assigned to one of three groups : Project Dulce – only ( PD ) ; Project Dulce technology-enhanced with mobile tools ( PD-TE ) ; or IMSS st and ard of care/control group ( CG )  . Clinical and self-reported outcomes were assessed at baseline , Month 4 , and Month 10 . Time-by-group interactions and within-group changes were analyzed . Results : HbA1c reductions from baseline to Month 10 were significantly greater in PD-TE ( −3.0 % [ −33 mmol/mol ] ) and PD ( −2.6 % [ −28.7 mmol/mol ] ) compared with CG ( −1.3 % [ −14.2 mmol/mol ] ) ( P = 0.009 and 0.001 , respectively ) . PD-TE and PD also exhibited significant improvement in diabetes knowledge when compared with CG ( P < 0.05 for both ) . No statistically significant differences were detected between PD and PD-TE on these indicators ( P = 0.54 and 0.86 , respectively ) . Several within-group improvements were observed on other clinical and self-report indicators but did not vary significantly across groups . Conclusions : Project Dulce with and without wireless technology  substantially improved glycemic control and diabetes knowledge in high-risk patients with type 2 diabetes in a Mexican family medical unit , suggesting that integrating peer-led education , nurse coordination , and 3 G wireless technology is an effective approach for improving diabetes outcomes in high-risk population Purpose The purpose of this study is to test the efficacy of a culturally tailored comprehensive type 2 diabetes management intervention for Korean American immigrants ( KAIs ) with type 2 diabetes . Methods A r and omized controlled pilot trial with 2 parallel arms ( intervention vs control ) with a delayed intervention design was used . A total of 79 KAIs , recruited from the Baltimore-Washington area , completed baseline , 18-week , and 30-week follow-ups ( intervention , n = 40 ; control , n = 39 ) . All participants had uncontrolled type 2 diabetes ( hemoglobin A1C ≥7.5 % ) at baseline . The authors ’ comprehensive , self-help intervention program for type 2 diabetes management ( SHIP-DM ) consisted of a 6-week structured psychobehavioral education , home glucose monitoring with teletransmission , and bilingual nurse telephone counseling for 24 weeks . The primary outcome of the study was A1C level , and secondary outcomes included an array of psychobehavioral variables . Results Using analysis of covariance , the findings support that the proposed intervention was effective in significantly lowering A1C and fasting glucose and also in improving psychosocial outcomes in the sample . Specifically , the amount of reduction in A1C among intervention group participants was 1.19 % at 18 weeks and 1.31 % at 30 weeks , with 10 % and 15.5 % of the participants achieving the suggested goal of A1C < 7 % at 18 and 30 weeks of follow-up , respectively . Conclusions The results highlight the clinical efficacy of the SHIP-DM intervention composed of a 6-week education program , self-monitoring , and follow-up counseling , in terms of maintaining the improved intervention effects obtained and in terms of glucose control Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control . We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes . Methods and Findings We performed a r and omized , parallel , investigator-blind controlled trial with central ized r and omization in family practice s in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin ( HbA1c ) > 58 mmol/mol . The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group . The control group received usual care , with at least annual review and more frequent review s for  people with poor glycemic or blood pressure control .  HbA1c assessed at 9 mo was the primary outcome . Intention-to-treat analyses were performed . 160 people were r and omized to the intervention group and 161 to the usual care group between June 6 , 2011 , and July 19 , 2013 .  HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group . The mean ( SD ) HbA1c at follow-up was 63.0 ( 15.5 ) mmol/mol in the intervention group and 67.8 ( 14.7 ) mmol/mol in the usual care group . For primary analysis , adjusted mean HbA1c was 5.60 mmol/mol / 0.51 % lower ( 95 % CI 2.38 to 8.81 mmol/mol/ 95 % CI 0.22 % to 0.81 % , p = 0·0007 ) . For secondary analyses , adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower ( 95 % CI 0.56–5.56 mmHg , p = 0.017 ) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower ( 95 % CI 0.62–3.72 , p = 0.006 ) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata . No significant differences were identified between groups in weight , treatment pattern , adherence to medication , or quality of life in secondary analyses . There were few adverse events and these were equally distributed between the intervention and control groups . In secondary analysis , there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group ( rate ratio 7.50 ( 95 % CI 4.45–12.65 , p < 0.0001 ) but no other significant differences between groups in use of health services were identified between groups . Key limitations include potential lack of representativeness of trial participants , inability to blind participants and health professionals , and uncertainty about the mechanism , the duration of the effect , and the optimal length of the intervention . Conclusions Supported telemonitoring result ed in clinical ly important improvements in control of glycaemia in patients with type 2 diabetes in family practice . Current Controlled Trials , registration number IS RCT N71674628 . Trial Registration Current Controlled Trials IS RCT N Background Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality . We evaluated the efficacy of a consultation-based intervention to support objective ly-assessed adherence to oral glucose lowering medication ( OGLM ) compared to usual care among people with type 2 diabetes . Methods This was a parallel group r and omised trial in adult patients with type 2 diabetes and HbA1c≥7.5 % ( 58 mmol/mol ) , prescribed at least one OGLM . Participants were allocated to a clinic nurse delivered , innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans , or to usual care . The primary outcome was the percentage of days on which the prescribed dose of medication was taken , measured objective ly over 12 weeks with an electronic medication-monitoring device ( TrackCap , Aardex , Switzerl and ) . The primary analysis was intention-to-treat . Results 211 patients were r and omised between July 1 , 2006 and November 30 , 2008 in 13 British general practice s ( primary care clinics ) . Primary outcome data were available for 194 participants ( 91.9 % ) . Mean ( sd ) percentage of adherent days was 77.4 % ( 26.3 ) in the intervention group and 69.0 % ( 30.8 ) in st and ard care ( mean difference between groups 8.4 % , 95 % confidence interval 0.2 % to 16.7 % , p = 0.044 ) . There was no significant adverse impact on functional status or treatment satisfaction . Conclusions This well-specified , theory based intervention delivered in a single session of 30 min in primary care increased objective ly measured medication adherence , with no adverse effect on treatment satisfaction . These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time , with clinical and cost-effectiveness outcomes to inform clinical practice .Trial registration Current Controlled Trials IS RCT ABSTRACT BACKGROUND Home wireless device monitoring could play an important role in improving the health of patients with poorly controlled chronic diseases , but daily engagement rates among these patients may be low . OBJECTIVE To test the effectiveness of two different magnitudes of financial incentives for improving adherence to remote-monitoring regimens among patients with poorly controlled diabetes . DESIGN R and omized , controlled trial . ( Clinical trials.gov Identifier : NCT01282957 ) . PARTICIPANTS Seventy-five patients with a hemoglobin A1c greater than or equal to 7.5 % recruited from a Primary Care Medical Home practice at the University of Pennsylvania Health System . INTERVENTIONS Twelve weeks of daily home-monitoring of blood glucose , blood pressure , and weight ( control group ; n = 28 ) ; a lottery incentive with expected daily value of $ 2.80 ( n = 26 ) for daily monitoring ; and a lottery incentive with expected daily value of $ 1.40 ( n = 21 ) for daily monitoring . MAIN MEASURES Daily use of three home-monitoring devices during the three-month intervention ( primary outcome ) and during the three-month follow-up period and change in A1c over the intervention period ( secondary outcomes ) .KEY RESULTS Incentive arm participants used devices on a higher proportion of days relative to control ( 81 % low incentive vs. 58 % , P = 0.007 ; 77 % high incentive vs. 58 % , P = 0.02 ) during the three-month intervention period . There was no difference in adherence between the two incentive arms ( P = 0.58 ) . When incentives were removed , adherence in the high incentive arm declined while remaining relatively high in the low incentive arm . In month 6 , the low incentive arm had an adherence rate of 62 % compared to 35 % in the high incentive arm ( P = 0.015 ) and 27 % in the control group ( P = 0.002 ) . CONCLUSIONS A daily lottery incentive worth $ 1.40 per day improved monitoring rates relative to control and had significantly better efficacy once incentives were removed than a higher incentive PURPOSE To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control , intermediate cardiovascular outcomes , satisfaction with care , and re source utilization . METHODS We conducted a r and omized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C ) ( HbA(1C ) ) levels > or=7.5 % . Two nurse practitioner case managers worked with patients and their primary care providers , monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts , collaborative goal setting , and treatment algorithms . Control patients received educational material s and usual care from their primary care providers . RESULTS At the conclusion of the study , both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C ) level ( 9.3 % vs. 9.2 % ; difference = 0.1 % ; 95 % confidence interval : -0.4 % to 0.7 % ; P = 0.65 ) . There was also no evidence that the intervention result ed in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy . However , intervention patients were substantially more satisfied with their diabetes care , with 82 % rating their providers as better than average compared with 64 % of patients in the control group ( P = 0.04 ) . CONCLUSION An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes . The type of patients targeted for intervention , organizational factors , and program structure are likely critical determinants of the effectiveness of case management . Health systems must underst and the potential limitations before expending substantial re sources on case management , as the expected improvements in outcomes and downstream cost savings may not always be realized Objective . Patients with type 2 diabetes often fail to achieve self-management goals . This study tested the impact on glycemic control of a two-way text messaging program that provided behavioral coaching , education , and testing reminders to enrolled individuals with type 2 diabetes in the context of a clinic-based quality improvement initiative . The secondary aim examined patient interaction and satisfaction with the program . Methods . Ninety-three adult patients with poorly controlled type 2 diabetes ( A1C > 8 % ) were recruited from 18 primary care clinics in three counties for a 6-month study . Patients were r and omized by a computer to one of two arms . Patients in both groups continued with their usual care ; patients assigned to the intervention arm also received from one to seven diabetes-related text messages per day depending on the choices they made at enrollment . At 90 and 180 days , A1C data were obtained from the electronic health record and analyzed to determine changes from baseline for both groups . An exit survey was used to assess satisfaction . Enrollment behavior and interaction data were pulled from a Web-based administrative portal maintained by the technology vendor . Results . Patients used the program in a variety of ways . Twenty-nine percent of program users demonstrated frequent engagement ( texting responses at least three times per week ) for a period of ≥90 days . Survey results indicate very high satisfaction with the program . Both groups ’ average A1C decreased from baseline , possibly reflecting a broader quality improvement effort underway in participating clinics . At 90 and 180 days , there was no statistically significant difference between the intervention and control groups in terms of change in A1C ( P > 0.05 ) . Conclusions . This study demonstrated a practical approach to implementing and monitoring a mobile health intervention for self-management support across a wide range of independent clinic practice Objective To determine the effectiveness of a patient decision aid ( PDA ) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster r and omised controlled trial ( RCT ) . Design A cluster RCT . Setting 49 general practice s in UK r and omised into intervention ( n=25 ) and control ( n=24 ) . Participants General practice s Inclusion criteria : > 4 medical partners ; list size > 7000 ; and a diabetes register with > 1 % of practice population . 191 practice s assessed for eligibility , and 49 practice s r and omised and completed the study . Patients People with type 2 diabetes mellitus ( T2DM ) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin ( HbA1c ) greater than 7.4 % ( IFCC HbA1c > 57 mmol/mol ) or advised in the preceeding 6 months to add or consider changing to insulin therapy . Exclusion criteria : currently using insulin therapy ; difficulty reading or underst and ing English ; difficulty in underst and  ing the purpose of the study ; visual or cognitive impairment or mentally ill . A total of 182 assessed for eligibility , 175 r and omised to 95 intervention and 80 controls , and 167 completion and analysis .  Intervention Brief training of clinicians and use of PDA with patients in single consultation . Primary outcomes Decision quality ( Decisional Conflict Scores , knowledge , realistic expectations and autonomy ) and glycaemic control ( glycosolated haemoglobin , HbA1c ) . Secondary outcomes Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications . Results Intervention group : lower total Decisional Conflict Scores ( 17.4 vs 25.2 , p<0.001 ) ; better knowledge ( 51.6 % vs 28.8 % , p<0.001 ) ; realistic expectations ( risk of ‘ hypo ’ , ‘ weight gain ’ , ‘ complications ’ ; 81.0 % vs 5.2 % , 70.5 % vs 5.3 % , 26.3 % vs 5.0 % respectively , p<0.001 ) ; and were more autonomous in decision-making ( 64.1 % vs 42.9 % , p=0.012 ) . No significant difference in the glycaemic control between the two groups . Conclusions Use of the P AND As decision aid reduces decisional conflict , improves knowledge , promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice . IS RCT N Trials Register Number 14842077 OBJECTIVE The Northern Manhattan Diabetes Community Outreach Project evaluated whether a community health worker ( CHW ) intervention improved clinical ly relevant markers of diabetes care in adult Hispanics . RESEARCH DESIGN AND METHODS Participants were adult Hispanics , ages 35–70 years , with recent hemoglobin A1c ( A1C ) ≥8 % ( ≥64 mmol/mol ) , from a university-affiliated network of primary care practice s in northern Manhattan ( New York City , NY ) . They were r and omized to a 12-month CHW intervention ( n = 181 ) , or enhanced usual care ( educational material s mailed at 4-month intervals , preceded by phone calls , n = 179 ) . The primary outcome was A1C at 12 months ; the secondary outcomes were systolic blood pressure ( SBP ) , diastolic blood pressure , and LDL-cholesterol levels . RESULTS There was a nonsignificant trend toward improvement in A1C levels in the intervention group ( from unadjusted mean A1C of 8.77 to 8.40 % ) , as compared with usual care ( from 8.58 to 8.53 % ) ( P = 0.131 ) . There was also a nonsignificant trend toward an increase in SBP and LDL cholesterol in the intervention arm . Intervention fidelity , measured as the number of contacts in the intervention arm ( visits , phone contacts , group support , and nutritional education ) , showed a borderline association with greater A1C reduction ( P = 0.054 ) . When assessed separately , phone contacts were associated with greater A1C reduction ( P = 0.04 ) . CONCLUSIONS The trend toward A1C reduction with the CHW intervention failed to achieve statistical significance . Greater intervention fidelity may achieve better glycemic control , and more accessible treatment models , such as phone-based interventions , may be more efficacious in socioeconomically disadvantaged population OBJECTIVE To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes . MATERIAL S AND METHODS Engaging and Motivating Patients Online With Enhanced Re sources for Diabetes was a 12-month parallel r and omized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin ( A1C ) values ≥7.5 % from primary care sites sharing an electronic health record . The intervention included : ( 1 ) wirelessly uploaded home glucometer readings with graphical feedback ; ( 2 ) comprehensive patient-specific diabetes summary status report ; ( 3 ) nutrition and exercise logs ; ( 4 ) insulin record ; ( 5 ) online messaging with the patient 's health team ; ( 6 ) nurse care manager and dietitian providing advice and medication management ; and ( 7 ) personalized text and video educational ' nuggets ' dispensed electronically by the care team . A1C was the primary outcome variable . RESULTS Compared with usual care ( UC , n=189 ) , patients in the intervention ( INT , n=193 ) group had significantly reduced A1C at 6 months ( -1.32 % INT vs -0.66 % UC ; p<0.001 ) . At 12 months , the differences were not significant ( -1.14 % INT vs -0.95 % UC ; p=0.133 ) . In post hoc analysis , significantly more INT patients had improved diabetes control ( > 0.5 % reduction in A1C ) than UC patients at 12 months ( 69.9 ( 95 % CI 63.2 to 76.5 ) vs 55.4 ( 95 % CI 48.4 to 62.5 ) ; p=0.006 ) . CONCLUSIONS A nurse-led , multidisciplinary health team can manage a population of diabetic patients in an online disease management program . INT patients achieved greater decreases in A1C at 6 months than UC patients , but the differences were not sustained at 12 months . More INT than UC patients achieved improvement in A1C ( > 0.5 % decrease ) . Trial registered in clinical trials.gov : # NCT00542204 OBJECTIVE Despite the importance of self-management support ( SMS ) , few studies have compared SMS interventions , involved diverse population s , or entailed implementation in safety net setting s. We examined the effects of two SMS strategies across outcomes corresponding to the Chronic Care Model . RESEARCH DESIGN AND METHODS A total of 339 out patients with poorly controlled diabetes from county-run clinics were enrolled in a three-arm trial . Participants , more than half of whom spoke limited English , were uninsured , and /or had less than a high school education , were r and omly assigned to  usual care , interactive weekly automated telephone self-management support with nurse follow-up ( ATSM ) , or monthly group medical visits with physician and health educator facilitation ( GMV ) . We measured 1-year changes in structure ( Patient Assessment of Chronic Illness Care [ PACIC ] ) , communication processes ( Interpersonal Processes of Care [ IPC ] ) , and outcomes ( behavioral , functional , and metabolic ) . RESULTS Compared with the usual care group , the ATSM and GMV groups showed improvements in PACIC , with effect sizes of 0.48 and 0.50 , respectively ( P < 0.01 ) . Only the ATSM group showed improvements in IPC ( effect sizes 0.40 vs. usual care and 0.25 vs. GMV , P < 0.05 ) . Both SMS arms showed improvements in self-management behavior versus the usual care arm ( P < 0.05 ) , with gains being greater for the ATSM group than for the GMV group ( effect size 0.27 , P = 0.02 ) . The ATSM group had fewer bed days per month than the usual care group ( −1.7 days , P = 0.05 ) and the GMV group ( −2.3 days , P < 0.01 ) and less interference with daily activities than the usual care group ( odds ratio 0.37 , P = 0.02 ) . We observed no differences in A1C change . CONCLUSIONS Patient-centered SMS improves certain aspects of diabetes care and positively influences self-management behavior . ATSM seems to be a more effective communication vehicle than GMV in improving behavior and quality of life Background Health outcomes for Indigenous Australians with diabetes in remote areas remain poor , including high rates of avoidable complications which could be reduced with better primary level care . We aim ed to evaluate the effectiveness of a community-based health-worker led case management approach to the care of Indigenous adults with poorly controlled type 2 diabetes in primary care services in remote northern Australia . Methods Two hundred and thirteen adults with poorly controlled diabetes ( HbA1c > 8.5 % ) and significant comorbidities in 12 remote communities were r and omly assigned by service cluster to receive chronic care co-ordination from a community-based health worker supported by a clinical outreach team , or to a waitlist control group which received usual care . Results At baseline , mean age of participants was 47.9 years , 62.4 % were female , half were Aboriginal and half identified as Torres Strait Isl and er , 67 % had less than 12 years of education , 39 % were smokers , median income was $ 18,200 and 47 % were unemployed .  Mean HbA1c was 10.7 % ( 93 mmol/mol ) and BMI 32.5 . At follow-up after 18 months , HbA1c reduction was significantly greater in the intervention group ( −1.0 % vs −0.2 % , SE ( diff ) = 0.2 , p = 0.02 ) . There were no significant differences between the groups for blood pressure , lipid profile , BMI or renal function . Intervention group participants were more likely to receive nutrition and dental services according to scheduled care plans . Smoking rates were unchanged . Conclusions A culturally safe , community level health-worker led model of diabetes care for high risk patients can be effective in improving diabetes control in remote Indigenous Australian communities where there is poor access to mainstream services . This approach can be effective in other remote setting s , but requires longer term evaluation to capture accrued benefits .Trial registration ANZCTR 12610000812099 , Registered 29 September 2010 BACKGROUND The effects of intensive glucose control on cardiovascular events in patients with long-st and ing type 2 diabetes mellitus remain uncertain . METHODS We r and omly assigned 1791 military veterans ( mean age , 60.4 years ) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or st and ard glucose control . Other cardiovascular risk factors were treated uniformly . The mean number of years since the diagnosis of diabetes was 11.5 , and 40 % of the patients had already had a cardiovascular event . The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level , as compared with the st and ard-therapy group . The primary outcome was the time from r and omization to the first occurrence of a major cardiovascular event , a composite of myocardial infa rct ion , stroke , death from cardiovascular causes , congestive heart failure , surgery for vascular disease , inoperable coronary disease , and amputation for ischemic gangrene . RESULTS The median follow-up was 5.6 years . Median glycated hemoglobin levels were 8.4 % in the st and ard-therapy group and 6.9 % in the intensive-therapy group . The primary outcome occurred in 264 patients in the st and ard-therapy group and 235 patients in the intensive-therapy group ( hazard ratio in the intensive-therapy group , 0.88 ; 95 % confidence interval [ CI ] , 0.74 to 1.05 ; P=0.14 ) . There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause ( hazard ratio , 1.07 ; 95 % CI , 0.81 to 1.42 ; P=0.62 ) . No differences between the two groups were observed for microvascular complications . The rates of adverse events , predominantly hypoglycemia , were 17.6 % in the st and ard-therapy group and 24.1 % in the intensive-therapy group . CONCLUSIONS Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events , death , or microvascular complications with the exception of progression of albuminuria ( P = 0.01 ) [ added ] . ( Clinical Trials.gov number , NCT00032487 . OBJECTIVE To evaluate the effect of a culturally sensitive diabetes self-management education program that uses a low-cost , peer-educator format ( Project Dulce ) on glucose control and metabolic parameters in low-income Mexican Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 207 Mexican-American patients recruited from federally funded community health centers in San Diego County with HbA1c > 8 % were r and omly assigned to the  Project Dulce peer intervention or continuation of st and ard diabetes care . The primary outcome of interest was HbA1c . RESULTS The majority of subjects were born in Mexico , were female , were middle-aged , had less than an eighth- grade education , and had high baseline HbA1c levels . Significant time-by-group interaction effects for HbA1c ( P = 0.02 ) and diastolic blood pressure ( P = 0.04 ) indicated that the Project Dulce group exhibited greater improvement ( i.e. , decreases ) across time . Within-group analyses showed that the intervention group exhibited significant improvements from baseline to month 4 in absolute levels of HbA1c ( −1.7 % , P = 0.001 ) and HDL cholesterol ( + 1.4 mg/dL , P = 0.01 ) and from baseline to month 10 in absolute levels of HbA1c ( −1.5 % , P = 0.01 ) , total cholesterol ( −7.2 mg/dL , P = 0.04 ) , HDL cholesterol ( + 1.6 mg/dL , P = 0.01 ) , and LDL cholesterol ( −8.1 mg/dL , P = 0.02 ) . No significant changes were noted in the control group . CONCLUSIONS This r and omized trial , using the Project Dulce model of culturally sensitive , peer-led education , demonstrates improvement in glucose and metabolic control and suggests that this low-cost approach to self-management education for high-risk diabetic population s is effective Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs . We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population . We also explored whether reductions in glycated hemoglobin ( HbA1c ) will be more marked in minority persons . Methods We conducted an open-label r and omized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5 % ( ≥58 mmol/mol ) . Participants were r and omized to : 1 ) a Chronic Disease Self-Management Program ( CDSMP ; n = 101 ) ; 2 ) a diabetes self-care software on a personal digital assistant ( PDA ; n = 81 ) ; 3 ) a combination of interventions ( CDSMP + PDA ; n = 99 ) ; or 4 ) usual care ( control ; n = 95 ) . Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice . The primary outcome was change in HbA1c from r and omization to 12 months . Data were analyzed using a multilevel statistical model . Results Average baseline HbA1c in the CDSMP , PDA , CDSMP + PDA , and control arms were 9.4 % , 9.3 % , 9.2 % , and 9.2 % , respectively . HbA1c reductions at 12 months for the groups averaged 1.1 % , 0.7 % , 1.1 % , and 0.7 % , respectively and did not differ significantly from baseline based on the model ( P = .771 ) . Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts ( P < .004 ) , no other significant differences were observed in participants ’ diabetes self-care activities . Exploratory sub- analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups . Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control , these interventions did not fare significantly better than usual care in achieving glycemic control . More research is needed to underst and how these interventions can be most effective in clinical practice . The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control . Trial registration Clinical trials.gov Identifier : NCT01221090 BACKGROUND The Veterans Affairs Diabetes Trial previously showed that intensive glucose lowering , as compared with st and ard therapy , did not significantly reduce the rate of  major cardiovascular events among 1791 military veterans ( median follow-up , 5.6 years ) . We report the extended follow-up of the study participants . METHODS After the conclusion of the clinical trial , we followed participants , using central data bases to identify procedures , hospitalizations , and deaths ( complete cohort , with follow-up data for 92.4 % of participants ) . Most participants agreed to additional data collection by means of annual surveys and periodic chart review s ( survey cohort , with 77.7 % follow-up ) . The primary outcome was the time to the first major cardiovascular event ( heart attack , stroke , new or worsening congestive heart failure , amputation for ischemic gangrene , or cardiovascular-related death ) . Secondary outcomes were cardiovascular mortality and all-cause mortality . RESULTS The difference in glycated hemoglobin levels between the intensive-therapy group and the st and ard-therapy group averaged 1.5 percentage points during the trial ( median level , 6.9 % vs. 8.4 % ) and declined to 0.2 to 0.3 percentage points by 3 years after the trial ended . Over a median follow-up of 9.8 years , the intensive-therapy group had a significantly lower risk of the primary outcome than did the st and ard-therapy group ( hazard ratio , 0.83 ; 95 % confidence interval [ CI ] , 0.70 to 0.99 ; P=0.04 ) , with an absolute reduction in risk of 8.6 major cardiovascular events per 1000 person-years , but did not have reduced cardiovascular mortality ( hazard ratio , 0.88 ; 95 % CI , 0.64 to 1.20 ; P=0.42 ) . No reduction in total mortality was evident ( hazard ratio in the intensive-therapy group , 1.05 ; 95 % CI , 0.89 to 1.25 ; P=0.54 ; median follow-up , 11.8 years ) . CONCLUSIONS After nearly 10 years of follow-up , patients with type 2 diabetes who had been r and omly assigned to intensive glucose control for 5.6 years had 8.6 fewer major cardiovascular events per 1000 person-years than those assigned to st and ard therapy , but no improvement was seen in the rate of overall survival . ( Funded by the VA Cooperative Studies Program and others ; VADT Clinical Trials.gov number , NCT00032487 . ) Background There is a paucity of evidence supporting the effectiveness of diabetes self-management education ( DSME ) in improving mental health-related quality of life ( HRQoL ) for African American and Latinos . Also , among studies supporting the favorable effects of DSME on mental HRQoL , the direct effect of DSME that is independent of improved glycemic control has never been investigated . The objectives of this study were to investigate the effect of community-based DSME intervention targeting empowerment on mental HRQoL and to determine whether the effect is direct or mediated by glycemic control . Methods We conducted secondary analyses of data from the Diabetes Self-Care Study , a r and omized controlled trial of a community-based DSME intervention . Study participants ( n = 516 ) were African Americans and Latinos 55 years or older with poorly controlled diabetes ( HbA1c ≥ 8.0 % ) recruited from senior centers and churches in Los Angeles . The intervention group received six weekly small-group self-care sessions based on the empowerment model . The control group received six lectures on unrelated geriatrics topics . The primary outcome variable in this secondary analysis was the change in Mental Component Summary score ( MCS-12 ) from the SF-12 Health Survey between baseline and six-month follow-up . We used the change in HbA1c during the study period as the main mediator of interest in our causal mediation analysis . Additionally , possible mediations via social support and perceived empowerment attributable to the program were examined . Results MCS-12 increased by 1.4 points on average in the intervention group and decreased by 0.2 points in the control group ( difference-in-change : 1.6 points , 95 % CI : 0.1 to 3.2 ) . In the causal mediation analysis , the intervention had a direct effect on MCS-12 improvement ( 1.7 points , 95 % CI : 0.2 to 3.2 ) with no indirect effects mediated via HbA1c change ( −0.1 points , 95 % CI : −0.4 to 0.1 ) , social support ( 0.1 points ) , and perception of empowerment ( 0.1 points ) . Conclusions This Diabetes Self-Care Study empowerment intervention had a modest positive impact on mental HRQoL not mediated by the improvement in glycemic control , as well as social support and perception of empowerment . This favorable effect on mental HRQoL may be a separate clinical advantage of this DSME intervention . Trial Registration Clinical Trial.gov NCT00263835 OBJECTIVE To evaluate the effectiveness of a culturally adapted , primary care – based nurse – community health worker ( CHW ) team intervention to support diabetes self-management on diabetes control and other biologic measures . RESEARCH DESIGN AND METHODS Two hundred sixty-eight Samoan participants with type 2 diabetes were recruited from a community health center in American Samoa and were r and omly assigned by village clusters to the nurse-CHW team intervention or to a wait-list control group that received usual care . RESULTS Participants had a mean age of 55 years , 62 % were female , mean years of education were 12.5 years , 41 % were employed , and mean HbA1c was 9.8 % at baseline . At 12 months , mean HbA1c was significantly lower among CHW participants , compared with usual care , after adjusting for confounders ( b = −0.53 ; SE = 0.21 ; P = 0.03 ) . The odds of making a clinical ly significant improvement in HbA1c of at least 0.5 % in the CHW group was twice the odds in the usual care group after controlling for confounders ( P = 0.05 ) . There were no significant differences in blood pressure , weight , or waist circumference at 12 months between groups . CONCLUSIONS A culturally adapted nurse-CHW team intervention was able to significantly improve diabetes control in the U.S. Territory of American Samoa . This represents an important translation of an evidence -based model to a high-risk population and a re source -poor setting Objective To evaluate the effectiveness of goal focused telephone coaching by practice nurses  in improving glycaemic control in patients with type 2 diabetes in Australia . Design Prospect i ve , cluster r and omised controlled trial , with general practice s as the unit of r and omisation . Setting General practice s in Victoria , Australia . Participants 59 of 69 general practice s that agreed to participate recruited sufficient patients and were r and omised . Of 829 patients with type 2 diabetes ( glycated haemoglobin ( HbA1c ) > 7.5 % in the past 12 months ) who were assessed for eligibility , 473 ( 236 from 30 intervention practice s and 237 from 29 control practice s ) agreed to participate . Intervention Practice nurses from intervention practice s received two days of training in a telephone coaching programme , which aim ed to deliver eight telephone and one face to face coaching episodes per patient . Main outcome measures The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group . Results The intervention and control patients were similar at baseline . None of the practice s dropped out over the study period ; however , patient attrition rates were 5 % in each group ( 11/236 and 11/237 in the intervention and control group , respectively ) . The median number of coaching sessions received by the 236 intervention patients was 3 ( interquartile range 1 - 5 ) , of which 25 % ( 58/236 ) did not receive any coaching sessions . At 18 months ’ follow-up the effect on glycaemic control did not differ significantly ( mean difference 0.02 , 95 % confidence interval −0.20 to 0.24 , P=0.84 ) between the intervention and control groups , adjusted for HbA1c measured at baseline and the clustering . Other biochemical and clinical outcomes were similar in both groups . Conclusions A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia . The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective . Trial registration Current Controlled Trials IS RCT N50662837 OBJECTIVE To evaluate the effect of case management by a clinical pharmacist on glycemic control and preventive measures in patients with type 2 diabetes mellitus . STUDY DESIGN R and omized controlled trial in a university-affiliated primary care internal medicine clinic . METHODS We recruited 80 patients with poorly controlled type 2 diabetes mellitus . A clinical pharmacist provided evaluation and modification of pharmacotherapy , self-management diabetes education , and reinforcement of diabetes complications screening processes through clinic visits and telephone follow-up . The main clinical outcome was hemoglobin A1C ( HbA1C ) level ; process measures included HbA1C and low-density lipoprotein measurement , retinal examination , urine microalbumin testing ( or use of angiotensin-converting enzyme inhibitors ) , and monofilament screening for diabetic neuropathy . RESULTS Patients in the intervention and control groups were similar in age , sex , mean HbA1C levels ( 10.1 % and 10.2 % , respectively ; P = .65 ) , and current treatment regimens at baseline . Patients who received case management by the clinical pharmacist achieved greater reduction in HbA1C levels than those in the control group ( 2.1 % vs 0.9 % , P = .03 ) . Three of the 5 process measures were conducted more frequently in the intervention group than the control group , including low-density lipoprotein measurement ( 100.0 % vs 85.7 % , P = .02 ) , retinal examination ( 97.3 % vs 74.3 % ) , and monofilament foot screening ( 92.3 % vs 62.9 % ) . CONCLUSIONS Proactive diabetes case management by a pharmacist substantially improved glycemic control and diabetes process-of-care measures . This approach , integrated with and based in the primary care setting , was an effective and efficient approach to improving care , especially for those with poor glycemic control at baseline PURPOSE Peer health coaches offer a potential model for extending the capacity of primary care practice s to provide self-management support for patients with diabetes . We conducted a r and omized controlled trial to test whether clinic-based peer health coaching , compared with usual care , improves glycemic control for low-income patients who have poorly controlled diabetes . METHOD We undertook a r and omized controlled trial enrolling patients from 6 public health clinics in San Francisco . Twenty-three patients with a glycated hemoglobin ( HbA1C ) level of less than 8.5 % , who completed a 36-hour health coach training class  , acted as peer coaches .  Patients from the same clinics with HbA1C levels of 8.0 % or more were recruited and r and omized to receive health coaching ( n = 148 ) or usual care ( n = 151 ) . The primary outcome was the difference in change in HbA1C levels at 6 months . Secondary outcomes were proportion of patients with a decrease in HbA1C level of 1.0 % or more and proportion of patients with an HbA1C level of less than 7.5 % at 6 months . Data were analyzed using a linear mixed model with and without adjustment for differences in baseline variables . RESULTS At 6 months , HbA1C levels had decreased by 1.07 % in the coached group and 0.3 % in the usual care group , a difference of 0.77 % in favor of coaching ( P = .01 , adjusted ) . HbA1C levels decreased 1.0 % or more in 49.6 % of coached patients vs 31.5 % of usual care patients ( P = .001 , adjusted ) , and levels at 6 months were less than 7.5 % for 22.0 % of coached vs 14.9 % of usual care patients ( P = .04 , adjusted ) . CONCLUSIONS Peer health coaching significantly improved diabetes control in this group of low-income primary care patients OBJECTIVE To evaluate the effectiveness of a psychological , family-based intervention to improve diabetes-related outcomes in patients with poorly controlled type 2 diabetes . METHODS This study was a r and omized controlled trial of a psychological family-based intervention targeted at individuals with poorly controlled type 2 diabetes . Recruitment and follow-up occurred at specialist diabetes clinics . Patients were r and omly allocated to an  intervention group ( n=60 ) or a control group ( n=61 ) . Poor control was defined as at least 2 of the patient 's last 3 glycated hemoglobin (  A1C  )  readings at > 8.0 % . The intervention consisted of 2 sessions delivered by a health psychologist to the patient and a family member in the patient 's home , with a third session involving a 15-minute follow-up telephone call . RESULTS At 6-month follow-up , the intervention group reported significantly lower mean A1C levels than the control group ( 8.4 % [ SD=0.99 % ] vs 8.8 % [ SD=1.36 % ] ; P=.04 ) . The intervention was most effective in those with the poorest control at baseline ( A1C>9.5 % ) ( intervention 8.7 % [ SD=1.16 % , n=15 ] vs control 9.9 % [ SD=1.31 % , n=15 ] ; P=.01 ) . The intervention group also reported statistically significant improvements in beliefs about diabetes , psychological well-being , diet , exercise , and family support . CONCLUSIONS After participating in a family-based intervention targeting negative and /or inaccurate illness perceptions , patients with poorly controlled type 2 diabetes showed improvements in A1C levels and other outcomes . Our results suggest that adding a psychological , family-based component to usual diabetes care may help improve diabetes management OBJECTIVE To investigate the effect of pharmacist management of poorly controlled diabetes mellitus in a community-based primary care group . STUDY DESIGN R and omized controlled trial of pharmacist management of diabetes compared with usual medical care . METHODS Patients 18 years or older with glycosylated hemoglobin ( A1C ) levels of 9.0 % or higher were enrolled . Patients were r and omly assigned to an intervention group ( n = 52 ) or a control group ( n = 51 ) . Management in the control group included the use of registries and targeted patient outreach . The intervention group participated in the same outreach program plus medication management , patient education , and disease control by a pharmacist . RESULTS Nonparametric data showed median A1C decreases of 1.50 % for the intervention group and 0.40 % for the control group ( P = .06 ) . Significantly more patients in the intervention group improved their A1C level by at least 1.0 % relative to the control group ( 67.3 % vs 41.2 % , P = .02 ) . Most of this benefit was seen for patients of nonwhite race/ethnicity compared with control subjects ( 56.3 % vs 22.7 % , P = .03 ) . Male patients showed significantly greater benefit as well , with a median A1C decrease of 1.90 % vs 0.15 % for controls ( P = .03 ) . CONCLUSIONS Patients with poorly controlled diabetes improved A1C levels significantly when pharmacist management was added to an aggressive organizational diabetes management program . Our results suggest that clinical ly trained pharmacists can help primary care providers improve diabetes management , especially among male patients and among patients of nonwhite race/ethnicity ABSTRACT Background Several trials have demonstrated the efficacy of nurse telephone case management for diabetes ( DM ) and hypertension ( HTN ) in academic or vertically integrated systems . Little is known about the real-world potency of these interventions . Objective To assess the effectiveness of nurse behavioral management of DM and HTN in community practice s among patients with both diseases . Design The study was design ed as a patient-level r and omized controlled trial . Participants Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practice s. Subjects were required to have inadequately controlled DM ( hemoglobin A1c [ A1c ] ≥ 7.5 % ) but could have well-controlled HTN . Interventions All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years , for a total of 12 calls . Intervention patients received tailored DM- and HTN- focused behavioral content ; control patients received non-tailored , non-interactive information regarding health issues unrelated to DM and HTN ( e.g. , skin cancer prevention).Main Outcomes and Measures Systolic blood pressure ( SBP ) and A1c were co- primary outcomes , measured at 6 , 12 , and 24 months ; 24 months was the primary time point . Results Three hundred seventy-seven subjects were enrolled ; 193 were r and omized to intervention , 184 to control . Subjects were 55 % female and 50 % white ; the mean baseline A1c was 9.1 % ( SD = 1 % ) and mean SBP was 142 mmHg ( SD = 20 ) . Eighty-two percent of scheduled interviews were conducted ; 69 % of intervention patients and 70 % of control patients reached the 24-month time point . Expressing model estimated differences as ( intervention – control ) , at 24 months , intervention patients had similar A1c [ diff = 0.1 % , 95 % CI ( −0.3 , 0.5 ) , p = 0.51 ] and SBP [ diff = −0.9 mmH g , 95 % CI ( −5.4 , 3.5 ) , p = 0.68 ] values compared to control patients . Likewise , DBP ( diff = 0.4 mmHg , p = 0.76 ) , weight ( diff = 0.3 kg , p = 0.80 ) , and physical activity levels ( diff = 153 MET-min/week , p = 0.41 ) were similar between control and intervention patients . Results were also similar at the 6- and 12-month time points . Conclusions In nine community fee-for-service practice s , telephonic nurse case management did not lead to improvement in A1c or SBP . Gains seen in telephonic behavioral self-management interventions in optimal setting s may not translate to the wider range of primary care setting BACKGROUND : There is limited information from r and omized controlled studies about the influence of pharmacist interventions on diabetes control . OBJECTIVE : To evaluate the effect of a pharmacist intervention on improving diabetes control ; secondary endpoints were medication appropriateness and self-reported adherence . METHODS : A r and omized , controlled , multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics . Seventy-seven subjects , ⩾18 years old with a hemoglobin ( Hb ) A1c ⩾9 % at baseline and taking at least one oral diabetes medication , were r and omized to receive a pharmacist intervention ( n = 43 ) or usual care ( n = 34 ) for 6 months followed by a 6-month usual-care observation period for both groups . Subjects met with a clinical pharmacist to establish and initiate a diabetes care plan followed by weekly visits or telephone calls to facilitate diabetes management and adherence . HbA1c , medication appropriateness , and self-reported adherence were assessed at baseline , 6 months , and 12 months . RESULTS : The mean HbA1c did not differ between groups over the 12-month period ( p = 0.61 ) . A reduction in HbA1c was noted for both groups over time compared with baseline ( p = 0.001 ) ; however , control subjects relied more heavily on provider visits . Medication appropriateness was not improved for diabetes medications ( p = 0.65 ) . Self-reported adherence was not significantly improved by the intervention . CONCLUSIONS : This pharmacist intervention did not significantly improve diabetes control , but did allow for similar HbA1c control with fewer physician visits . Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P<0.0001 ) , 21 % for deaths related to diabetes ( 15 % to 27 % , P<0.0001 ) , 14 % for myocardial infa rct ion ( 8 % to 21 % , P<0.0001 ) , and 37 % for microvascular complications ( 33 % to 41 % , P<0.0001 ) . No threshold of risk was observed for any end point . Conclusions : In patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % ) BACKGROUND Disease management programs that include ongoing telephone support for patients with diabetes have shown promise , but published studies have enrolled few socially and economically disadvantaged patients . METHODS We conducted a r and omized controlled trial with 201 patients with poorly controlled type 2 diabetes mellitus ( 72 % African American or Latino ; 74 % with incomes of ≤$15,000 ) . Participants were r and omized to an intervention package consisting of a 24-minute video behavior support intervention with a workbook and 5 sessions of telephone coaching by a trained diabetes nurse or a 20-page brochure developed by the National Diabetes Education Program . Study measures were completed at baseline , 1 month , and 6 months . Participants ' review of the intervention material s was assessed at 1 month . The primary trial end point was hemoglobin A(1c ) value . Secondary end points included lipid levels , blood pressure , diabetes knowledge , and self-care behaviors . Data were analyzed with repeated measures analysis of variance . RESULTS Most participants in both groups ( 94 % ) review ed the intervention provided , and 73 % of participants assigned to the experimental group completed 5 sessions of telephone coaching . There was a significant overall reduction in mean ( SD ) hemoglobin A(1c ) value from baseline ( 9.6 % [ 2.0 % ] ) to 6 months ( 9.1 % [ 1.9 % ] ) ( P < .001 ) , but differences between groups were nonsignificant . Differences on other clinical measures ( lipid levels and blood pressure ) and measures of diabetes knowledge and self-care behaviors were also nonsignificant . CONCLUSIONS There was no significant effect of the experimental intervention compared with the control condition . The dose of intervention provided was less than in previously published studies . More intensive interventions may be necessary for the most disadvantaged patients . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00668590 BACKGROUND Group medical clinics ( GMCs ) are widely used in the management of diabetes and hypertension , but data on their effectiveness are limited . OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00286741 ) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia . PATIENTS 239 patients with poorly controlled diabetes ( hemoglobin A(1c ) [ HbA(1c ) ] level > or = 7.5 % ) and hypertension ( systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg ) . INTERVENTION Patients were r and omly assigned within each center to either attend a GMC or receive usual care . Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist , a pharmacist , and a nurse or other certified diabetes educator . Each session included structured group interactions moderated by the educator . The pharmacist and physician adjusted medication to manage each patient 's HbA(1c ) level and blood pressure . MEASUREMENTS Hemoglobin A(1c ) level and systolic blood pressure , measured by blinded research personnel at baseline , study midpoint ( median , 6.8 months ) , and study completion ( median follow-up , 12.8 months ) . Linear mixed models , adjusted for clustering within GMCs , were used to compare HbA(1c ) levels and systolic blood pressure between the intervention and control groups . RESULTS Mean baseline systolic blood pressure and HbA(1c ) level were 152.9 mm Hg ( SD , 14.2 ) and 9.2 % ( SD , 1.4 ) , respectively . At the end of the study , mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group ( P = 0.011 by linear mixed model ) , whereas mean HbA(1c ) level improved by 0.8 % in the GMC group and 0.5 % in the usual care group ( P = 0.159 ) . LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention . CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c ) level in diabetic patients . PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service BACKGROUND Compared with white persons , African Americans have a greater incidence of diabetes , decreased control , and higher rates of microvascular complications . A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes . OBJECTIVE To determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their  hemoglobin A(1c ) ( HbA(1c ) ) levels . DESIGN A 6-month r and omized , controlled trial . ( Clinical Trials.gov registration number : NCT01125956 ) SETTING Philadelphia Veterans Affairs Medical Center . PATIENTS African American veterans aged 50 to 70 years with persistently poor diabetes control . INTERVENTION 118 patients were r and omly assigned to 1 of 3 groups : usual care , a peer mentoring group , and a financial incentives group . Usual care patients were notified of their starting HbA(1c ) level and recommended goals for HbA(1c ) . Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control ( HbA(1c ) level ≤7.5 % ) . The mentor was asked to talk with the patient at least once per week . Peer mentors were matched by race , sex , and age . Patients in the financial incentive group could earn $ 100 by decreasing their HbA(1c ) level by 1 % and $ 200 by decreasing it by 2 % or to an HbA(1c ) level of 6.5 % . MEASUREMENTS Change in HbA(1c ) level at 6 months . RESULTS Mentors and mentees talked the most in the first month ( mean calls , 4 ; range , 0 to 30 ) , but calls decreased to a mean of 2 calls ( range , 0 to 10 ) by the sixth month . Levels of HbA(1c ) decreased from 9.9 % to 9.8 % in the control group , from 9.8 % to 8.7 % in the peer mentor group , and from 9.5 % to 9.1 % in the financial incentive group . Mean change in HbA(1c ) level from baseline to 6 months relative to control was -1.07 % ( 95 % CI , -1.84 % to -0.31 % ) in the peer mentor group and -0.45 % ( CI , -1.23 % to 0.32 % ) in the financial incentive group . LIMITATION The study included only veterans and lasted only 6 months . CONCLUSION Peer mentorship improved glucose control in a cohort of African American veterans with diabetes . PRIMARY FUNDING SOURCE National Institute on Aging Roybal Center AIMS To investigate the effectiveness of a diabetes virtual clinic to enhance diabetes in primary care by developing clinical management plans for patients with suboptimal metabolic control and /or case complexity . METHODS A prospect i ve study with r and omized allocation to virtual clinic or usual care .  Patients with Type 2 diabetes ( n = 208 ) were recruited from six general practice s in South London . The primary outcome for the study was glycaemic control , secondary outcomes included : lipids , blood pressure , weight ( kg and BMI ) and renal function ( eGFR ) . Data were collected from participants ' records at baseline and 12 months . We also considered process measures including therapy optimization . RESULTS The 12-month data show equivalence between the virtual clinic and control groups for glycaemic control with both achieving clinical ly significant reductions in HbA1c of 8 mmol/mol ( 0.6 ± 1.7 % ) and 10 mmol/mol ( 0.8 ± 1.9 % ) , respectively ( P = 0.4 ) . The virtual clinic group showed superiority over the intervention group for blood pressure control with a mean reduction in systolic blood pressure of 6 ± 16 mmHg compared with an increased of 2 ± 18 mmHg in the control group ( P = 0.008 ) . There were no significant differences between the groups in terms of cholesterol , weight and renal function . Process measures showed an increased level of therapy adjustment in the virtual clinic group . CONCLUSION The virtual clinic model explored in this study showed a clinical ly important improvement in glycaemic control . Although this improvement was not superior to that observed in the control participants , this might be attributable to the systemic impact of the virtual clinic on the practice as a whole BACKGROUND Re source barriers complicate diabetes care management . Support from peers may help patients manage their diabetes . OBJECTIVE To compare a reciprocal peer-support ( RPS ) program with nurse care management ( NCM ) . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00320112 ) SETTING 2 U.S. Department of Veterans Affairs health care facilities . PATIENTS 244 men with hemoglobin A(1c ) ( HbA(1c ) ) levels greater than 7.5 % during the previous 6 months . MEASUREMENTS The primary outcome was 6-month change in HbA(1c ) level . Secondary outcomes were changes in insulin therapy ; blood pressure ; and patient reports of medication adherence , diabetes-related support , and emotional distress . INTERVENTION Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals , receive peer communication skills training , and be paired with another age-matched peer patient . Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact . These patients could also participate in optional group sessions at 1 , 3 , and 6 months . Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager . RESULTS Of the 244 patients enrolled , 216 ( 89 % ) completed the HbA(1c ) assessment s and 231 ( 95 % ) completed the survey assessment s at 6 months . Mean HbA(1c ) level decreased from 8.02 % to 7.73 % ( change , -0.29 % ) in the RPS group and increased from 7.93 % to 8.22 % ( change , 0.29 % ) in the NCM group . The difference in HbA(1c ) change between groups was 0.58 % ( P = 0.004 ) . Among patients with a baseline HbA(1c ) level greater than 8.0 % , those in the RPS group had a mean decrease of 0.88 % , compared with a 0.07 % decrease among those in the NCM group ( between-group difference , 0.81 % ; P < 0.001 ) . Eight patients in the RPS group started insulin therapy , compared with 1 patient in the NCM group ( P = 0.020 ) . Groups did not differ in blood pressure , self-reported medication adherence , or diabetes-specific distress , but the RPS group reported improvement in diabetes social support . LIMITATION The study included only male veterans and lasted only 6 months . CONCLUSION Reciprocal peer support holds promise as a method for diabetes care management OBJECTIVE This study evaluated the efficacy of a nurse-care management system design ed to improve outcomes in patients with complicated diabetes . RESEARCH DESIGN AND METHODS In this r and omized controlled trial that took place at Kaiser Permanente Medical Center in Santa Clara , CA , 169 patients with longst and ing diabetes , one or more major medical comorbid conditions , and HbA(lc ) > 10 % received a special intervention ( n = 84 ) or usual medical care ( n = 85 ) for 1 year . Patients met with a nurse-care manager to establish individual outcome goals , attended group sessions once a week for up to 4 weeks , and received telephone calls to manage medications and self-care activities .  HbA(lc ) , LDL , HDL , and total cholesterol , triglycerides , fasting glucose , systolic and diastolic blood pressure , BMI , and psychosocial factors were measured at baseline and 1 year later . Annualized physician visits were determined for the year before and during the study . RESULTS At 1 year , the mean reductions in HbA(lc ) , total cholesterol , and LDL cholesterol were significantly greater for the intervention group compared with the usual care group . Significantly more patients in the intervention group met the goals for HbA(1c ) ( < 7.5 % ) than patients in usual care ( 42.6 vs. 24.6 % , P < 0.03 , chi(2 ) ) . There were no significant differences in any of the psychosocial variables or in physician visits . CONCLUSIONS A nurse-care management program can significantly improve some medical outcomes in patients with complicated diabetes without increasing physician visits Abstract .Practicing physicians as well as diabetes specialists are confronted with the often-frustrating experience of dealing with patients with poorly controlled diabetes . It is not always obvious why these patients fail to improve . The aims of this study were two-fold : ( a ) to determine if the interdisciplinary approach offered by the Western Negev  Mobile Clinic Diabetes Program ( WNMDCP ) is of benefit in patients with poorly controlled type 2 diabetes and ( b ) to more fully characterize patients refractory to treatment . Two primary -care clinics of the Western Negev were r and omly selected as control and intervention . All patients from both clinics with hemoglobin ( HbA1C ) ≥10 % ( tested during June-July 2000 ) were studied for 6 months . Patients from the control clinic continued the usual treatment . Patients from the intervention clinic received the interdisciplinary approach offered by WNMCDP . The rate of improvement of diabetes control , measured as a decrease in HbA1C values of at least 0.5 % , and compliance to treatment were determined . Overall , 48 of 258 patients in the intervention clinic and 34 of 179 patients in the control clinic met the inclusion criteria . At the 6-month follow-up , we observed significant improvements in plasma glucose ( -1.5 mmol/l ; p=0.003 ) and HbA1C ( -1.8 % ; p=0.00001 ) in the intervention group but not in the control group . The compliance and response rates were 85 % and 71 % for the intervention group and 32 % and 35 % for the control group , respectively . Patients from the intervention clinic showed significant improvement in the endpoints compared to patients from the control clinic . More than 70 % of patients with poorly controlled diabetes mellitus responded to the interdisciplinary treatment approach offered by WNMDCP . The group of non-responders comprised patients with poor compliance ( 15 % ) and those with serious concomitant diseases or limitations of mobility BACKGROUND We evaluated how a structured patient/physician self-monitoring of blood glucose ( SMBG ) intervention influenced the timing , frequency , and effectiveness of primary care physicians ' treatment changes with type 2 diabetes mellitus ( T2DM ) patients over 12 months . METHODS The Structured Testing Program ( STeP ) study was a cluster-r and omized , multicenter trial with 483 poorly controlled , insulin-naive T2DM subjects . Primary care practice s were r and omized to the Active Control Group ( ACG ) or the Structured Testing Group ( STG ) , the latter of which included quarterly review of structured SMBG results . STG patients used a paper tool that graphs seven-point glucose profiles over 3 consecutive days ; physicians received a treatment algorithm based on SMBG patterns . Impact of structured SMBG on physician treatment modification recommendations ( TMRs ) and glycemic outcomes was examined . RESULTS More STG than ACG patients received a TMR at each study visit ( P < 0.0001 ) . Of patients who received at least one TMR , STG patients demonstrated a greater reduction in glycated hemoglobin A1c ( HbA1c ) than ACG patients ( -1.2 % vs. -0.8 % , P < 0.03 ) . Patients with a  baseline HbA1c  ≥8.5 % who received a TMR at the Month 1 visit experienced greater reductions in HbA1c ( P = 0.002 ) than patients without an initial TMR . More STG than ACG patients were started on incretins ( P < 0.01 ) and on thiazolidinediones ( P = 0.004 ) . The number of visits with a TMR was unrelated to HbA1c change over time . CONCLUSIONS Patient-provided SMBG data contribute to glycemic improvement when blood glucose patterns are easy to detect , and well-trained physicians take timely action . Collaborative use of structured SMBG data leads to earlier , more frequent , and more effective TMRs for poorly controlled , non-insulin-treated T2DM subjects OBJECTIVES To demonstrate that pharmacists working with physicians and other providers in an ambulatory care setting can improve glucose , blood pressure , and lipid control for patients with type 2 diabetes and to report patient adherence to screening and general preventive measures . DESIGN Prospect i ve , r and omized , clinical practice study . SETTING Burlington , MA , between January 2001 and August 2003 . PATIENTS 164 patients patients with type 2 diabetes older than 18 years with glycosylated hemoglobin ( A1C ) greater than 8 % . INTERVENTION Pharmacist-patient clinic visits included obtaining a comprehensive medication review ; performing targeted physical assessment ; ordering laboratory tests ; review ing , modifying , and monitoring patients ' medication therapy and providing detailed counseling on all therapies ; facilitating self-monitoring of blood glucose ; and providing reinforcement of dietary guidelines and exercise . MAIN OUTCOME MEASURE Effect of clinical pharmacists working with physicians in an ambulatory setting on health measures ( e.g. , A1C , blood pressure , cholesterol ) of patients with diabetes . RESULTS Baseline characteristics were similar between the two groups . After 1 year , significant improvements occurred for A1C and low-density lipoprotein ( LDL ) cholesterol in the intervention group compared with the control group ( A1C , 7.7 % vs. 8.4 % ; LDL , 93.7 vs. 105.1 mg/dL ; P < 0.05 ) . Systolic blood pressure improved for all study patients without a difference between the two groups . Diastolic blood pressure improved significantly in the intervention group compared with the control group ( 73.4 mm Hg vs. 77.6 mm Hg , P < 0.05 ) . Significantly more intervention patients were screened for retinopathy , neuropathy , and microalbuminuria than control patients ( P < 0.05 ) . CONCLUSION For all indices measured , this study demonstrated that collaborative diabetes management with a clinical pharmacist can improve overall care Objectives This r and omized controlled trial investigated whether a patient-centered supportive counseling intervention comprising monthly telephone-based counseling sessions by practice nurses over 12 months improved diabetes-related medical and psycho-social outcomes above usual care in type 2 diabetes patients with poor glycemic control at baseline ( HbA1c > 7.5 % ) in a primary care setting . Research Design Patients were individually r and omized into intervention ( n = 103 ) and usual care group ( n = 101 ) . The primary outcome was change in HbA1c-concentration after 12 and 18 months . Secondary outcomes were lipid levels , blood pressure , health-related quality of life and symptoms of depression . Follow-up- measurements were carried out after 6 , 12 and 18 months to assess potential immediate and maintained effects of the intervention . For the multivariate analysis , hierarchical linear models were computed for each outcome to assess within-group changes in outcomes over time and between-group differences in patterns of change . Results HbA1c ( in % ) decreased significantly from baseline to 12-month follow-up measurement both in the intervention ( −0.44 ) and the usual care group ( −0.51 ) , but there was no significant between-group intervention effect . Significant improvements in the intervention group along with significant between-group differences were seen for health-related quality of life and , transiently , for systolic blood pressure and depression . Conclusions Although we found no beneficial effect of the supportive telephone counseling in terms of a reduction of HbA1c above usual care , our findings suggest some beneficial effects on cardiovascular risk factors , quality of life and depression . Continuous efforts might be needed to sustain improvements in patient outcomes . Trial Registration Clinical Trials.gov OBJECTIVE Disparities exist in the diabetes health status of ethnic minority and /or low-income population s relative to other groups . A primary objective of diabetes management is to improve glycemic control . The feasibility of implementing intensive diabetes case management in disparate population s remains largely untested . RESEARCH DESIGN AND METHODS Clinical sites in three southern California counties serving low-income , ethnic minority population s participated in our study . We r and omized 362 Medicaid ( called Medi-Cal in California ) recipients with type 2 diabetes for at least 1 year to intervention ( diabetes case management ) or control ( traditional primary care treatment ) groups . Fifty-five percent of participants were minorities . Participants with HbA(1c ) levels less than 7.5 % , serious diabetes-related complications , or other serious medical conditions were excluded . We assessed the effect of the intervention ( ongoing diabetes case management added to primary care ) on glycemic control using serial HbA(1c ) measurements over several years . RESULTS The mean duration of follow-up was 25.3 months . HbA(1c ) decreased substantially in both groups from an average of 9.54 - 7.66 % ( a reduction of 1.88 % ) in the intervention group and from an average of 9.66 - 8.53 % ( a reduction of 1.13 % ) in the control group . This improvement was sustained throughout the study . The reduction in HbA(1c ) was consistently greater in the intervention group at each time point ( P < 0.001 ) , ranging between 0.65 at 6 months and 0.87 at study end . CONCLUSIONS Diabetes case management , added to primary care , substantially improved glycemic control compared with the control group . Diabetes case management can help reduce disparities in diabetes health status among low-income ethnic population PURPOSE To assess the efficacy of a pharmacist-led , primary care-based , disease management program to improve cardiovascular risk factors and glycated hemoglobin ( A(1C ) ) levels in vulnerable patients with poorly controlled diabetes . METHODS A r and omized controlled trial of 217 patients with type 2 diabetes and poor glycemic control ( A(1C ) level > or=8.0 % ) was conducted at an academic general medicine practice from February 2001 to April 2003 . Intervention patients received intensive management from clinical pharmacists , as well as from a diabetes care coordinator who provided diabetes education , applied algorithms for managing glucose control and decreasing cardiovascular risk factors , and addressed barriers to care . Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider . Outcomes were recorded at baseline and at 6 and 12 months . Primary outcomes included blood pressure , A(1C ) level , cholesterol level , and aspirin use . Secondary outcomes included diabetes knowledge , satisfaction , use of clinical services , and adverse events . RESULTS For the 194 patients ( 89 % ) with 12-month data , the intervention group had significantly greater improvement than did the control group for systolic blood pressure ( -9 mm Hg ; 95 % confidence interval [ CI ] : -16 to -3 mm Hg ) and A(1C ) level ( -0.8 % ; 95 % CI : -1.7 % to 0 % ) . Change in total cholesterol level was not significant . At 12 months , aspirin use was 91 % in the intervention group versus 58 % among controls ( P < 0.0001 ) . Intervention patients had greater improvements in diabetes knowledge and satisfaction than did control patients . There were no significant differences in use of clinical services or adverse events . CONCLUSION Our comprehensive disease management program reduced cardiovascular risk factors and A(1C ) levels among vulnerable patients with type 2 diabetes and poor glycemic control OBJECTIVE To test trial design issues related to measuring the effectiveness of a peer telephone intervention to enhance self-efficacy in type 2 diabetes ; evaluate the impact on self-efficacy and clinical outcome ; and describe patient and peer experience . METHODS Eligible patients had raised HbA1c ( initial threshold > 8 % , reduced to > 7.4 % mid-way through trial ) . Patients were recruited from 40 general practice s and r and omised ( 40:40:20 ratio ) to receive routine care alone or , in addition ,  motivational telephone support from a peer supporter or a diabetes specialist nurse ( 9 peers and 12 DSNs ) for a period of up to 6 months . The primary outcome measure was self-efficacy score , and secondary outcome measures included HbA1c . Patient and telecare supporter satisfaction and experience were evaluated . RESULTS In all , 231 patients participated . At 6 months there were no statistically significant differences in self-efficacy scores ( p=0.68 ) , HbA1c ( p=0.87 ) or other secondary outcome measures . There was evidence of a high level of acceptability , but peer telecare support was less highly valued than that from a DSN . Some patients stated that they would have valued more information and advice . CONCLUSIONS Further consideration needs to be given to the targeting of the telecare peer support , its intensity , the training and ongoing supervision of peer supporters , and the extent to which information and advice should be incorporated . PRACTICE IMPLICATION S While some patients with poorly controlled type 2 diabetes value peer telephone support , this approach appears not to suit all patients . Further intervention development and evaluation is required before widespread adoption can be recommended Diabetes is defined by its association with hyperglycemia-specific microvascular complications ; however , it also imparts a two- to fourfold risk of cardiovascular disease ( CVD ) . Although microvascular complications can lead to significant morbidity and premature mortality , by far the greatest cause of death in people with diabetes is CVD . Results from r and omized controlled trials have demonstrated conclusively that the risk of microvascular complications can be reduced by intensive glycemic control in patients with type 1 ( 1,2 ) and type 2 diabetes ( 3–5 ) . In the Diabetes Control and Complications Trial ( DCCT ) , there was an ∼60 % reduction in development or progression of diabetic retinopathy , nephropathy , and neuropathy between the intensively treated group ( goal A1C < 6.05 % , mean achieved A1C ∼7 % ) and the st and ard group ( A1C ∼9 % ) over an average of 6.5 years . The relationship between glucose control ( as reflected by the mean on- study A1C value ) and risk of complications was log-linear and extended down to the normal A1C range ( < 6 % ) with no threshold noted . In the UK Prospect i ve Diabetes Study ( UKPDS ) , participants newly diagnosed with type 2 diabetes were followed for 10 years , and intensive control ( median A1C 7.0 % ) was found to reduce the overall microvascular complication rate by 25 % compared with conventional treatment ( median A1C 7.9 % ) . Here , too , secondary analyses showed a continuous relationship between the risk of microvascular complications and glycemia extending into the normal range of A1C , with no glycemic threshold . On the basis of these two large controlled trials , along with smaller studies and numerous epidemiologic reports , the consistent findings related to microvascular risk reduction with intensive glycemic control have led the American Diabetes Association ( ADA ) to recommend an A1C goal of < 7 % for most adults with diabetes ( 6 ) , recognizing that more or less stringent goals may be appropriate for certain patients . Whereas many epidemiologic studies and meta-analyses
target: Subgroup analyses suggested that organisational interventions and interventions on those with baseline HbA1c over 9.5 % had better improvements in HbA1c .
  Interventions had a modest improvement of blood pressure and lipids , although baseline levels of control were generally good .
  Conclusions This review suggests that interventions for T2DM , in primary care , are better targeted at individuals with very poor glycaemic control and that organisational interventions may be more effective
background: Objectives Poorly controlled type 2 diabetes mellitus ( T2DM ) is a major international health problem .