title: Randomized controlled trial of the effects of nurse case manager and community health worker interventions on risk factors for diabetes-related complications in urban African Americans. The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes. A nurse-coordinated intervention for primary care patients with non-insulin-dependent diabetes mellitus 3-Year Follow-up of Clinical and Behavioral Improvements Following a Multifaceted Diabetes Care Intervention Impact of a diabetes control and management intervention on health care utilization in American Samoa Impact of a Community Health Workers–Led Structured Program on Blood Glucose Control Among Latinos With Type 2 Diabetes: The DIALBEST Trial Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial Case management for patients with poorly controlled diabetes: a randomized trial. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial. Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care Patient education in type 2 diabetes: a randomized controlled 1-year follow-up study. Effects of a tailored lifestyle self-management intervention in patients with type 2 diabetes. Living Well With Diabetes: 24-Month Outcomes From a Randomized Trial of Telephone-Delivered Weight Loss and Physical Activity Intervention to Improve Glycemic Control Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System: a randomized controlled trial. 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 Diabetes Intervention Study: Multi-Intervention Trial in Newly Diagnosed NIDDM A trial of empowerment-based education in type 2 diabetes--global rather than glycaemic benefits. Are benefits from diabetes self-management education sustained? Beyond good intentions: The role of proactive coping in achieving sustained behavioural change in the context of diabetes management Group Education for Obese Patients with Type 2 Diabetes: Greater Success at Less Cost Nurse-Led Behavioral Management of Diabetes and Hypertension in Community Practices: A Randomized Trial The relative effectiveness of self-management programs for type 2 diabetes. Effectiveness of a Multicomponent Quality Improvement Strategy to Improve Achievement of Diabetes Care Goals: A Randomized, Controlled Trial. Specialist nurse-led intervention to treat and control hypertension and hyperlipidemia in diabetes (SPLINT): a randomized controlled trial. A Pharmacotherapy Follow-Up Program in Patients with Type-2 Diabetes in Community Pharmacies in Spain Experience-based group education in Type 2 diabetes: a randomised controlled trial. Medical Clinics Versus Usual Care for Patients With Both Diabetes and Hypertension Multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: the Microalbuminuria Education and Medication Optimisation (MEMO) study. Optimizing diabetes control in people with Type 2 diabetes through nurse-led telecoaching. Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes? Starting insulin in type 2 diabetes: continue oral hypoglycemic agents? A randomized trial in primary care. Effects of a cognitive behavioural treatment in patients with type 2 diabetes when added to managed care; a randomised controlled trial Effectiveness of home telehealth in comorbid diabetes and hypertension: a randomized, controlled trial. Evaluation of a nurse-care management system to improve outcomes in patients with complicated diabetes. An assessment of structured care assistance in the management of patients with type 2 diabetes in general practice. Effectiveness of a Supportive Telephone Counseling Intervention in Type 2 Diabetes Patients: Randomized Controlled 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. Effectiveness of lifestyle counseling by certified expert nurse of Japan for non-insulin-treated diabetic outpatients: a 1-year randomized controlled trial. Results of a randomized controlled trial comparing closed‐suction drains versus passive gravity drains after pancreatic resection☆, ☆☆
abstract: BACKGROUND African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention .  The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income < $ 10,000 . Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients Abstract OBJECTIVE : To examine the impact of a nurse-coordinated intervention delivered to patients with non-insulin-dependent diabetes mellitus between office visits to primary care physicians . DESIGN : R and omized , controlled trial . SETTING : Veterans Affairs general medical clinic . PATIENTS : 275 veterans who had NIDDM and were receiving primary care from general internists . INTERVENTION : Nurse-initiated contacts were made by telephone at least monthly to provide patient education ( with special emphasis on regimens and significant signs and symptoms of hyperglycemia and hypoglycemia ) , reinforce compliance with regimens , monitor patients ’ health status , facilitate resolution of identified problems , and facilitate access to primary care . MEASUREMENTS : Glycemic control was assessed using glycosylated hemoglobin ( GHb ) and fasting blood sugar ( FBS ) levels . Health-related quality of life ( HRQOL ) was measured with the Medical Outcomes Study SF-36 , and diabetes-related symptoms were assessed using patients ’ self-reports of signs and symptoms of hyper- and hypoglycemia during the previous month . MAIN RESULTS : At one year , between-group differences favored intervention patients for FBS ( 174.1 mg/dL vs 193.1 mg/dL , p=0.011 ) and GHb ( 10.5 % vs 11.1 % , p=0.046 ) . Statistically significant differences were not observed for either SF-36 scores ( p=0.66 ) or diabetes-related symptoms ( p=0.23 ) . CONCLUSIONS : The intervention , design ed to be a pragmatic , low-intensity adjunct to care delivered by physicians , modestly improved glycemic control but not HRQOL or diabetes-related symptoms Purpose The purpose of this study was to determine if improvements observed in clinical , behavioral , and psychosocial outcomes measured at 12 months following a multifaceted diabetes care intervention were sustained at 3-year follow-up . Methods This study was a multilevel , nonblinded , cluster design , r and omized controlled trial that took place in an under-served suburb of Pittsburgh , Pennsylvania , between 1999 and 2005 . Eleven primary care practice s , and their patients , were r and omly assigned to 3 groups :  chronic care model ( CCM ) intervention ( n = 30 ) , provider education only ( PROV ) ( n = 38 ) , and usual care ( UC ) ( n = 51 ) . Subjects were followed for 3 years . Results Improvements observed at 12-month follow-up in glycemic ( —0.5 % ) and blood pressure control ( —4.8 mm Hg ) , and the proportion of participants who self-monitor their blood glucose ( 86.7%-100 % ) , were sustained at 3-year follow-up in the CCM group . Additional improvements occurred in non-HDLc levels in all study groups and quality of well-being scores in the CCM intervention group . All associations remained after controlling for medication treatment intensification . Conclusions We have demonstrated that improvements in outcomes can be sustained over time following a multifaceted diabetes care intervention . Future research in this area is necessary to underst and if improvements in outcomes can be sustained following diabetes self-management education ( DSME ) and what type of patient fares the best from multifaceted diabetes care interventions Objectives To examine the impact of a successful 12-month behavioral intervention to improve diabetes control on health care utilization in American Samoa . Methods A cluster-r and omized design was used to assign 268 diabetes patients to a nurse-community health worker intervention or usual care .  Hospitalizations , emergency department , and primary care physician visits were collected retrospectively for 1 year prior to , and during , the intervention to assess changes in health care utilization . The association of utilization changes with change in HbA1c during the intervention was assessed . Results Adjusted incidence rate ratios ( RR ) for primary care physician visits were significantly higher in the community health worker relative to the usual care group ( RR = 1.71 ; 95 % CI , 1.25–2.33 ) . There was no main intervention effect on emergency department utilization , but visits in the prior year modified the intervention effect on emergency department visits . Increased primary care physician utilization was associated with greater decreases in HbA1c ( b = −0.10 , SE = 0.04 , p = 0.01 ) . Conclusions A culturally adapted community health worker diabetes intervention in American Samoa significantly increased primary care physician visits , and decreased emergency department visits among those with high emergency department usage in the prior year . These changes suggest important and beneficial impacts on health system utilization from the diabetes intervention in a low re source and high-risk population OBJECTIVE Latinos with type 2 diabetes ( T2D ) face major healthcare access and disease management disparities . We examined the impact of the  Diabetes Among Latinos Best Practice s Trial ( DIALBEST ) , a community health worker (CHW)–led structured intervention for improving glycemic control among Latinos with T2D . RESEARCH DESIGN AND METHODS A total of 211 adult Latinos with poorly controlled T2D were r and omly assigned to a st and ard of healthcare ( n = 106 ) or CHW ( n = 105 ) group . The CHW intervention comprised 17 individual sessions delivered at home by CHWs over a 12-month period . Sessions addressed T2D complications , healthy lifestyles , nutrition , healthy food choices and diet for diabetes , blood glucose self-monitoring , and medication adherence . Demographic , socioeconomic , lifestyle , anthropometric , and biomarker ( HbA1c , fasting blood glucose , and lipid profile ) data were collected at baseline and 3 , 6 , 12 , and 18 months ( 6 months postintervention ) . Groups were equivalent at baseline . RESULTS Participants had  high HbA1c at baseline ( mean 9.58 % [ 81.2 mmol/mol ] ) . Relative to participants in the control group , CHWs had a positive impact on net HbA1c improvements at 3 months ( −0.42 % [ −4.62 mmol/mol ] ) , 6 months ( −0.47 % [ −5.10 mmol/mol ] ) , 12 months ( −0.57 % [ −6.18 mmol/mol ] ) , and 18 months ( −0.55 % [ −6.01 mmol/mol ] ) . The overall repeated- measures group effect was statistically significant ( mean difference −0.51 % [ −5.57 mmol/mol ] , 95 % CI −0.83 , −0.19 % [ −9.11 , −2.03 mmol/mol ] , P = 0.002 ) . CHWs had an overall significant effect on fasting glucose concentration that was more pronounced at the 12- and 18-month visits . There was no significant effect on blood lipid levels , hypertension , and weight . CONCLUSIONS DIALBEST is an effective intervention for improving blood glucose control among Latinos with T2D BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p<0·001 ) . These differences persisted to 12 months , despite less use of diabetes drugs . Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health 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 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE To evaluate the efficacy of ongoing group based diabetes self-management education ( DSME ) for patients with type 2 diabetes . METHODS 146 patients were r and omised to either group education or waiting list control . Primary outcomes were A1C and patient activation measured with patient activation measure ( PAM ) . RESULTS There were no differences in the primary outcomes between the groups at 12 months , but the control group had an increase in A1C of 0.3 % points during follow-up . Diabetes knowledge and some self-management skills improved significantly in the intervention group compared to the control group . A sub group analysis was conducted for the quartile with the highest A1C at baseline ( > 7.7 , n=18 in both groups ) . There were significant improvements within the intervention group at 12 month follow-up for both A1C and PAM and a trend for better outcome in the intervention group compared to the control . CONCLUSIONS The locally developed ongoing diabetes self-management education programs prevented an increase in A1C and can have an effect on A1C in patients with higher A1C level . PRACTICE IMPLICATION S Locally developed programs may be less effective than programs developed for studies Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years . Design Three year follow-up of a multicentre cluster r and omised controlled trial in primary care , with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 731 of the 824 participants included in the original trial were eligible for follow-up . Biomedical data were collected on 604 ( 82.6 % ) and question naire data on 513 ( 70.1 % ) participants . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures The primary outcome was glycated haemoglobin ( HbA1c ) levels . The secondary outcomes were blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , emotional impact of diabetes , and drug use at three years . Results HbA1c levels at three years had decreased in both groups . After adjusting for baseline and cluster the difference was not significant ( difference −0.02 , 95 % confidence interval −0.22 to 0.17 ) . The groups did not differ for the other biomedical and lifestyle outcomes and drug use . The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years ( P<0.01 ) . Depression scores and quality of life did not differ at three years . Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs . Trial registration Current Controlled Trials IS RCT N17844016 The aim of the present study was to evaluate the impact of empowerment group education on  type 2 diabetes patients '  confidence in diabetes knowledge , self-efficacy , satisfaction with daily life , BMI and glycaemic control compared with the impact of routine diabetes care on the same factors at a 1-year follow-up . In this r and omized controlled trial , conducted at 7 primary care centres in central Sweden , 101 patients were r and omly assigned either to  empowerment group education ( intervention group )  or to  routine diabetes care ( control group )  . Out of these , 42 patients in the intervention group and 46 in the control group completed the 1-year follow-up . Before the intervention and at the 1-year follow-up , the patients answered a 27-item question naire , and weight , BMI and HbA1c were measured . The question naire comprised three domains : confidence in diabetes knowledge , self-efficacy and satisfaction with daily life . At 1-year follow-up , the level of confidence in diabetes knowledge was significantly higher in the intervention group than in the control group ( p<0.05 ) . No significant differences were found in self-efficacy , satisfaction with daily life , BMI and HbA1c between the intervention and control group . The empowerment group education did improve  patients ' confidence in diabetes knowledge with maintained glycaemic control despite the progressive nature of the disease OBJECTIVES The aim of the present study was to develop , implement and evaluate a brief intervention to improve adherence to the recommended lifestyle changes for patients with Type 2 diabetes , in particular to help patients to reduce the total amount of fat consumed and to increase lifestyle physical activity levels . DESIGN AND METHOD A brief , tailored lifestyle self-management intervention for patients with Type 2 diabetes was evaluated in a r and omized controlled trial . One hundred participants ( aged 40 - 70 yrs ) completed assessment s at three time points- baseline , three months and one year . Participants were allocated to either an intervention group who received the brief tailored intervention including follow-up telephone calls , or a usual care control group . RESULTS Results indicate that the intervention was successful in helping patients to reduce fat intake and , to a lesser extent , increase lifestyle physical activity levels . These self-reported changes in behaviour were reflected in the objective data with weight maintenance in the intervention group compared to the control group , together with a significant reduction ( 2 cm ) in waist circumference . CONCLUSIONS These results provide further evidence of the effectiveness of tailored interventions for lifestyle change OBJECTIVE To evaluate the effectiveness of a telephone-delivered behavioral weight loss and physical activity intervention targeting Australian primary care patients with type 2 diabetes . RESEARCH DESIGN AND METHODS Pragmatic r and omized controlled trial of  telephone counseling ( n = 151 ) versus usual care ( n = 151 ) . Reported here are 18-month ( end-of-intervention ) and 24-month ( maintenance ) primary outcomes of weight , moderate-to-vigorous-intensity physical activity ( MVPA ; via accelerometer ) , and HbA1c level . Secondary outcomes include dietary energy intake and diet quality , waist circumference , lipid levels , and blood pressure . Data were analyzed via adjusted linear mixed models with multiple imputation of missing data . RESULTS Relative to usual-care participants , telephone counseling participants achieved modest , but significant , improvements in weight loss ( relative rate [ RR ] −1.42 % of baseline body weight [ 95 % CI −2.54 to −0.30 % of baseline body weight ] ) , MVPA ( RR 1.42 [ 95 % CI 1.06–1.90 ] ) , diet quality ( 2.72 [ 95 % CI 0.55–4.89 ] ) , and waist circumference ( −1.84 cm [ 95 % CI −3.16 to −0.51 cm ] ) , but not in HbA1c level ( RR 0.99 [ 95 % CI 0.96–1.02 ] ) , or other cardio-metabolic markers . None of the outcomes showed a significant change/deterioration over the maintenance period . However , only the intervention effect for MVPA remained statistically significant at 24 months . CONCLUSIONS The modest improvements in weight loss and behavior change , but the lack of changes in cardio-metabolic markers , may limit the utility , scalability , and sustainability of such an approach OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees 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 In a r and omized 5-yr multi-intervention trial , we tested the efficacy of intensified health education ( IHE ) in improving metabolic control and reducing the level of coronary risk factors and incidence of ischemic heart disease ( IHD ) . Research Design and Methods Within the intervention group , the benefit of clofibric acid was evaluated in a double-blind study . One thous and one hundred thirty-nine newly diagnosed middle-aged ( 30- to 55-yr-old ) patients with non-insulindependent diabetes mellitus ( NIDDM ) entered the study . They were classified as diet controlled after a 6- wk screening phase with conventional dietary treatment . During the follow-up , the control group ( n = 378 ) was cared for at different diabetes outpatient clinics with a st and ardized surveillance . The intervention group ( n = 761 ) had a structured IHE that included dietary advice , antismoking and antialcohol education , and ways to enhance physical activity . Results R and omly , 379 of the IHE patients received 1.6 g clofibric acid/day , and the others received placebo . IHE result ed in improved glucose control ( adjusted fasting blood glucose ) levels after 5 yr ( control subjects 9.27 mM , IHE group 8.71 mM , and IHE plus clofibric acid group 8.60 mM , P < 0.01 ) . The better glycemic control was achieved with fewer antidiabetic drugs . After 5 yr , antidiabetic drugs were prescribed to 47 % of the control subjects , 28 % of the IHE group , and 34 % of the IHE plus clofibric acid group ( cutoff limit for drug application was postpr and ial blood glucose of ≥13.87 mM ) . The ratio of polyunsaturated to saturated fatty acids ( 0.26 vs. 0.40 , P < 0.01 ) and physical activity ( 174 vs. 327 scores , P < 0.01 ) were increased , and blood pressure , tobacco , and alcohol consumption were significantly reduced by IHE . However , IHE had no effect on calorie intake , percentage of fat in the diet ( 45 % ) , and body weight . The most important finding was the significant increase of blood cholesterol in all three groups ( + 0.47 , + 0.36 , and + 0.34 mM , respectively ) . Clofibric acid only prevented the increase of triglyceride levels ( + 0.56 , + 0.24 , and + 0.05 mM , respectively ) . The incidence rate per 1000 for myocardial infa rct ion was 30.3 for control subjects , 53.6 for the IHE group , and 55.6 for the IHE plus clofibric acid group . The corresponding rates for IHD incidence were 90.9 , 97.8 , and 98.8 , respectively . Men suffered more frequently from myocardial infa rct ion , whereas women developed ECG criteria for IHD more frequently . Among the 35 cases of death , besides cardiovascular diseases , liver cirrhosis and neoplasia were the predominant causes . The death rate per 1000 in control subjects was 46.2 , 30.6 in the IHE group , and 27 among patients with IHE plus clofibric acid . Conclusions IHE was of substantial benefit for the control of glycemia , significantly diminished the need for antidiabetic drugs , and reduced a cluster of risk factors but had no effect on the control of blood lipids . This could be one major reason for the failure of IHE , effective lowering of blood pressure , and clofibric acid to prevent cardiovascular complications .  Clofibric acid was only effective in reducing triglycerides We have assessed the effect of a structured , empowerment-based educational system ( " LAY or " Look After Yourself " ) for patients with type 2 diabetes . A r and omised controlled trial ( RCT ) was conducted , testing the system against st and ard support . Using 3 centres , 89 patients participated in the study . Outcome measures included glycated haemoglobin ( HbA(1c ) ) , body mass index ( BMI ) and a variety of quantitative psychological and educational measures . Assessment was made at 6 months ( " short-term " ) and 12 months ( " long-term " ) post-intervention . The educational programme was associated with benefits in HbA(1c ) levels ( p=0.005 ) , illness attitudes ( p=0.04 ) , and perceived treatment effectiveness ( p=0.03 ) at 6 months follow-up compared to controls . At 12 months however , only illness attitudes ( p=0.01 ) , and self-monitoring ( p=0.002 ) showed benefit . A combined outcome measure showed positive benefit for the educational programme both at 6 months ( p=0.001 ) and 12 months ( p=0.002 ) . This structured educational programme , aim ed at encouraging self-help , was associated with only limited benefits in glycaemic control , but there were significant educational and psychological benefits . Diabetes education should be regarded as having broad patient-based positive outcomes , and should not be expected to have lasting benefits on glycaemic control OBJECTIVES To evaluate whether outcomes from diabetes self-management education for patients with suboptimal control were sustained . STUDY DESIGN A r and omized controlled trial of 623 adults with type 2 diabetes and glycated hemoglobin ( A1C ) > 7 % assigned to receive conventional individual education ( IE ) , group education ( GE ) using US Diabetes Conversation Maps , or usual care ( UC ) with no education . METHODS A1C tests , Problem Areas in Diabetes ( PAID ) , Diabetes Self-Efficacy ( DES ) , Recommended Food Score ( RFS ) , physical activity , and medication use were quantified at baseline and 1 year of follow-up through electronic health records and quarterly mailed surveys . Short-term ( mean 6.8 months ) and long-term ( 12.8 months ) outcomes were evaluated using linear mixed models . In addition , follow-up trajectories were plotted in a r and om effects generalized additive model with smooth splines . RESULTS Compared with UC , IE result ed in long-term improved DES and PAID scores ( DES , + .11 , P = .03 and PAID , -2.94 , P = .04 ) , but not significantly improved long-term RFS or physical activity change . The A1C trajectory declined more steeply in IE than GE and UC for the first 150 days post r and omization . However , by 250 days , there was no treatment group A1C difference . The model fit likelihood ratio test for A1C intervention trends was significant for 3 distinct non-linear trajectories ( P = .02 ) . CONCLUSIONS Conventional IE ( but not GE ) result ed in significant and sustained improvements in self-efficacy and reduced diabetes distress compared with UC , but short-term improvements in A1C , nutrition , and physical activity were not sustained . Patients may need ongoing reinforcement to achieve lasting behavioral change and glucose control This study examines the effectiveness of a brief self-management intervention to support patients recently diagnosed with type-2 diabetes to achieve sustained improvements in their self-care behaviours . Based on proactive coping , the intervention emphasizes the crucial role of anticipation and planning in maintaining self-care behaviours . In a r and omised controlled trial among recent screen-detected patients , participants who received the intervention  were compared with usual-care controls , examining changes in proximal outcomes ( intentions , self-efficacy and proactive coping ) , self-care behaviour ( diet , physical activity and medication ) and weight over time ( 0 , 3 and 12 months ) . Subsequently , the contribution of proactive coping in predicting maintenance of behavioural change was analysed using stepwise hierarchical regression analyses , controlling for baseline self-care behaviour , patient characteristics , and intentions and self-efficacy as measured after the course . The intervention was effective in improving proximal outcomes and behaviour with regard to diet and physical activity , result ing in significant weight loss at 12 months . Furthermore , proactive coping was a better predictor of long-term self-management than either intentions or self-efficacy . Proactive coping thus offers new insights into behavioural maintenance theory and can be used to develop effective self-management interventions It has been suggested that much effort expended in teaching diabetic diets is ineffective and wasteful . We have tested a different system by r and omly allocating 75 newly diagnosed obese Type 2 diabetic patients to usual ‘ unstructured ’ clinic care or to group education by diabetes specialist nurses and a dietitian . Patients allocated to group education attended five 90‐min group sessions during the first 6 months . Six months after diagnosis they had lost more weight ( median ( 95 % CI ) , 7 ( 5.5–9 ) vs 2 ( 1–5 ) kg , p<0.002 ) and were better controlled ( HbA1 : 7.5 ( 7.0–8.1 ) vs 9.5 ( 8.7–10.4 ) % , p<0.001 ) than those r and omized to the usual clinic system . At 1 year ( after no further visits ) the difference in weight loss was less ( 5.5 ( 4–6.5 ) vs 3 ( 2–4 ) kg , p<0.05 ) and diabetic control was similar ( HbA1:9.0 ( 8.2–9.8 ) vs 9.9 ( 8.9–10.9 ) % . At 1 year only 14 ( 39 % ) of the education group and 9 ( 23 % ) of those attending the clinic had a fasting blood glucose less than 7.0 mmol l−1 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 OBJECTIVES The objectives of the study were to investigate the effectiveness of 2 types of peer-led self-management programs in bringing about improvements in subjects with type 2 diabetes mellitus and to determine whether there were differences in effectiveness between the 2 programs . METHODS The study used a 3-arm r and omized controlled trial design with clinical measures taken at baseline and at 6 and 12 months post-program . In total , 405 persons completed baseline question naires and were r and omly allocated to a diabetes self-management program ( n=130 ) , to a general self-management program ( n=109 ) or to a control group ( n=122 ) . A 2-way factorial analyses of variance was employed as the primary statistical analysis . RESULTS The findings showed that the self-management programs had affected 5 of the 30 measures : fatigue , cognitive symptom management , self-efficacy with regard to the disease in general , communication with physician , and the score on the Diabetes Empowerment Scale . In addition , 3 variables-social role limitations , total hospital nights and glycated hemoglobin levels-showed marginally significant interaction effects . The second analysis found similar results , with 4 of the 5 measures remaining statistically significant : fatigue , cognitive symptom management , communication with physician and diabetes empowerment , with neither program being more effective than the other . CONCLUSIONS The major findings are that although both programs were effective in bringing about positive changes in the outcome measures , there was little difference in effectiveness between the Diabetes Self-Management Program and the Chronic Disease Self-Management Program . This finding is consistent with the principle that behaviour-change strategies using self-efficacy are key components in health education programs BACKGROUND Achievement of diabetes care goals is suboptimal globally . Diabetes-focused quality improvement ( QI ) is effective but remains untested in South Asia . OBJECTIVE To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes . DESIGN Parallel , open-label , pragmatic r and omized , controlled trial . ( Clinical Trials.gov : NCT01212328 ) . SETTING Diabetes clinics in India and Pakistan . PATIENTS 1146 patients ( 575 in the intervention group and 571 in the usual care group ) with type 2 diabetes and poor cardiometabolic profiles ( glycated hemoglobin [ HbA1c ] level ≥8 % plus systolic blood pressure [ BP ] ≥140 mm Hg and /or low-density lipoprotein cholesterol [ LDLc ] level ≥130 mg/dL ) .  INTERVENTION Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records . MEASUREMENTS Proportions achieving HbA1c level less than 7 % plus BP less than 130/80 mm Hg and /or LDLc level less than 100 mg/dL ( primary outcome ) ; mean risk factor reductions , health-related quality of life ( HRQL ) , and treatment satisfaction ( secondary outcomes ) . RESULTS Baseline characteristics were similar between groups . Median diabetes duration was 7.0 years ; 6.8 % and 39.4 % of participants had preexisting cardiovascular and microvascular disease , respectively ; mean HbA1c level was 9.9 % ; mean BP was 143.3/81.7 mm Hg ; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months , a greater percentage of intervention participants achieved the primary outcome ( 18.2 % vs. 8.1 % ; relative risk , 2.24 [ 95 % CI , 1.71 to 2.92 ] ) . Compared with usual care , intervention participants achieved larger reductions in HbA1c level ( -0.50 % [ CI , -0.69 % to -0.32 % ] ) , systolic BP ( -4.04 mm Hg [ CI , -5.85 to -2.22 mm Hg ] ) , diastolic BP ( -2.03 mm Hg [ CI , -3.00 to -1.05 mm Hg ] ) , and LDLc level ( -7.86 mg/dL [ CI , -10.90 to -4.81 mg/dL ] ) and reported higher HRQL and treatment satisfaction . LIMITATION Findings were confined to urban specialist diabetes clinics . CONCLUSION Multicomponent QI improves achievement of diabetes care goals , even in re source -challenged clinics . PRIMARY FUNDING SOURCE National Heart , Lung , and Blood Institute and UnitedHealth Group OBJECTIVE To determine the effectiveness of specialist nurse-led clinics for hypertension and hyperlipidemia provided for diabetic patients receiving hospital-based care . RESEARCH DESIGN AND METHODS This study was a r and omized controlled implementation trial at Hope Hospital , Salford , U.K. The subjects consisted of 1,407 subjects presenting for annual review with raised blood pressure(>or=140/80 mmHg ) , raised total cholesterol ( > or=5.0 mmol/l ) , or both . Individuals with diabetes were r and omized to usual care or usual care with subsequent invitation to attend  specialist nurse-led clinics . Nurses provided clinics for participants , with attendance every 4 - 6 weeks , until targets were achieved . Lifestyle advice and titration of drug therapies were provided according to the locally agreed upon guidelines . Patients with both conditions were eligible for enrollment in either or both clinics . At subsequent annual review , blood pressure and total cholesterol values were obtained from the Salford electronic diabetes register . Data relating to deaths were obtained from the national strategic tracing service . The primary outcome was the odds ratio of achieving targets in hypertension and hyperlipidemia , attributable to the  specialist nurse-led intervention . RESULTS Overall , specialist nurse-led clinics were associated with a significant improvement in patients achieving the target after 1 year ( odds ratio [ OR ] 1.37 [ 95 % CI 1.11 - 1.69 ] , P = 0.003 ) . This primary analysis revealed a borderline difference in effect between the two types of clinics ( test for interaction between groups : P = 0.06 ) . Secondary analysis , consistent with the prior beliefs of the health care professionals involved , suggested that targets were achieved more frequently in patients enrolled in the specialist nurse-led clinic for hyperlipidemia ( OR 1.69 [ 1.25 - 2.29 ] , P = 0.0007 ) than for hypertension ( OR 1.14 [ 0.86 - 1.51 ] , P = 0.37 ) . Intervention ( enrolled to either or both clinics ) was associated with a reduction in all-cause mortality ( OR 0.55 [ 0.32 - 0.92 ] , P = 0.02 ) . CONCLUSIONS This study provides good evidence to support the use of specialist nurse-led clinics as an effective adjunct to hospital-based care of patients with diabetes . If the st and ards of care recommended in the National Service Framework for Diabetes are to be achieved , then such proven methods for delivering care must be adopted Objective Poor metabolic control and high associated morbidity and mortality among type 2 diabetic patients require a level of care from the pharmacist that goes beyond usual dispensing . The aim of the present study was to evaluate the improvement in metabolic control , the resolution of drug-related problems ( DRPs ) and the increase in patient awareness of diabetes as outcomes of a pharmacotherapy follow-up program in type 2 diabetic patients . Method R and omized controlled trial conducted in 14 community pharmacies in the province of Pontevedra ( Spain ) with 112 patients between February 2003 and March 2004 . The control group received the usual care , and the intervention group patients were included in a pharmacotherapy follow-up program . This individualized program , which consists of the detection and resolution of DRPs and diabetes education , involves patients in their own care in order to obtain maximum benefit from the medication they use . Main outcome measures HbA1c , Fasting Blood Glucose ( FBG ) , lipid profile , blood pressure , body mass index ( BMI ) , DRPs and knowledge were evaluated at the onset of the program and periodically until conclusion . Results There was a significant difference in changes from baseline between the intervention and the control group in DRPs ( 1.7±1.2 versus 3.1±1.2 P<0.0001 ) , knowledge ( 17.9±3.7 versus 11.4±6.7 points P<0.0001 ) , HbA1c ( 7.9±1.7 versus 8.5±1.9 % P<0.0001 ) , FBG ( 154±61.3 versus 168±57.8 mg/dl P=0.0004 ) , total cholesterol ( 202±41.5 versus 217±43.5 mg/dl P=0.0054 ) and SBP ( 135±16.4 versus 150±19.9 mmHg P=0.0006 ) . Conclusions A substantial number of patients showed an improvement in their outcomes for the chosen metabolic indicators . Pharmacotherapy follow-up programs conducted by community pharmacists can play an important role in achieving therapeutic goals in patients with type 2 diabetes . This study shows that the incorporation of type 2 diabetic patients in a pharmacotherapy follow-up program may contribute to achieve positive clinical outcomes and will contribute to the implementation and progress of pharmacotherapy follow-up programs in community pharmacies Few studies have demonstrated an effect of educational interventions on glycaemic control in persons with Type 2 diabetes longer than 3 - 6 months after baseline . We aim ed to investigate the effectiveness of an experience-based group educational programme 24 months after baseline and to pinpoint mediators that might play a role in achieving desired metabolic outcomes . We conducted a r and omised controlled trial inviting self-referred persons with Type 2 diabetes ( N=77 r and omised ) . The pharmacist-led , year-long intervention was based on participants ' experiences of glucose regulation during the monthly group discussion s. We measured HbA1c at 0 , 6 , 12 , and 24 months and a question naire was administered at baseline and final follow-up . Our findings indicated that participating in the intervention programme significantly decreased HbA1c by 0.4 % at 24 months after baseline . Initial HbA1c , satisfaction with own diabetes-related knowledge , and treatment were found directly related to glycaemic outcomes . The intervention group exercised more in order to lower blood-glucose levels and was also more able to predict current blood-glucose levels before measuring it . Experience-based group education was effective in decreasing participants ' HbA1c 1-year after completed intervention . Early effect of the intervention was followed by relapse after 12 months and a new , significant decrease at 24 months ; this dual course implies that follow-up of educational interventions should involve several consecutive measurements to capture possible late effects . Both biomedical and subjective factors played a role in accounting for the variance of HbA1c at 2-year follow-up after baseline 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 AIMS To determine whether tighter cardiovascular risk factor control with structured education in individuals with type 2 diabetes ( T2DM ) and microalbuminuria benefits cardiovascular risk factors . METHODS Participants from a multiethnic population , recruited from primary care and specialist clinics were r and omised to intensive intervention with structured patient ( DESMOND model ) education ( n=94 ) or usual care by own health professional ( n=95 ) . PRIMARY OUTCOME change in HbA1c at 18months . SECONDARY OUTCOMES changes in blood pressure ( BP ) , cholesterol , albuminuria , proportion reaching risk factor targets , modelled cardiovascular risk scores . RESULTS Mean ( SD ) age and diabetes duration of participants were 61.5 ( 10.5 ) and 11.5 ( 9.3 ) years , respectively . At 18months , intensive intervention showed significant improvements in HbA1c ( 7.1(1.0 ) vs. 7.8(1.4)% , p<0.0001 ) , systolic BP ( 129(16 ) vs. 139(17 ) mmHg , p<0.0001 ) , diastolic BP ( 70(11 ) vs. 76(12 ) mmHg , p<0.001 ) , total cholesterol ( 3.7(0.8 ) vs. 4.1(0.9 ) mmol/l , p=0.001 ) . Moderate and severe hypoglycaemia was 11.2 vs. 29.0 % ; p=0.001 and 0 vs. 6.3 % ; p=0.07 , respectively . More intensive participants achieved ≥3 risk factor targets with greater reductions in cardiovascular risk scores . CONCLUSIONS Intensive intervention showed greater improvements in metabolic control and cardiovascular risk profile with lower rates of moderate and severe hypoglycaemia . Intensive glycaemic interventions should be underpinned by structured education promoting self-management in T2DM AIMS To study the effect of a target-driven telecoaching intervention on HbA1c and other modifiable risk factors in people with Type 2 diabetes . METHODS We conducted a r and omized controlled trial in patients receiving hypoglycaemic agents .  The primary outcome was HbA1c level at 6 months in the entire sample and in a subgroup with HbA1c levels ≥ 53 mmol/mol ( 7 % ) at baseline . Secondary outcomes were HbA1c at 18 months ; total cholesterol , LDL , HDL , triglycerides , blood pressure , BMI and proportion of people who had achieved guideline -recommended targets at 6 and 18 months . RESULTS A total of 287 participants were r and omized to telecoaching and 287 to usual care .  The mean ( sd ) baseline HbA1c level was 53 ( 11 ) mmol/mol [ 7.0 (1.0)% ] overall and 63 ( 10 ) mmol/mol [ 7.9 (0.9)% ] in the elevated HbA1c subgroup . At 6 months , the between-group differences in favour of telecoaching were : HbA1c -2 ( 95 % CI -4 ; -1 ) mmol/mol [ -0.2 ( 95 % CI -0.3;-0.1)% ; P=0.003 ] overall and -4 ( 95 % CI -7 ; -2 ) mmol/mol [ -0.4 ( 95 % CI -0.7 ; -0.2)% ; P=0.001 ] in the elevated HbA1c subgroup ; BMI -0.4 kg/m(2 ) ( 95 % CI -0.6 ; -0.1 ; P=0.003 ) ; total cholesterol -6 mg/dl ( 95 % CI -11 ; -1 , P=0.012 ) . The proportion of participants on target for the composite of HbA1c , LDL and blood pressure increased by 8.9 % in the intervention group and decreased by 1.3 % in the control group ( P=0.011 ) . At 18 months , the difference in HbA1c was : -2 ( 95 % CI -3;-0 ) mmol/mol [ -0.2 ( 95 % CI -0.3 ; -0.0)% ; P=0.046 ] overall and -4 ( -7 ; -1 ) mmol/mol [ -0.4 ( 95 % CI -0.7 ; -0.1)% ; P=0.023 ] in the elevated HbA1c subgroup . CONCLUSION Nurse-led telecoaching  improved glycaemic control , total cholesterol levels and BMI in people with Type 2 diabetes . Twelve months after the intervention completion , there were sustained improvements in glycaemic control PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes . SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system . Patients were r and omly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator . Outcomes measured at 12 months included survey-reported self-care , perceived glycemic control , and symptoms , as well as glycosylated hemoglobin ( Hb A1c ) and serum glucose levels . RESULTS We collected follow-up data for 89 % of enrollees ( 248 patients ) . Compared with usual care patients , intervention patients reported more frequent glucose monitoring , foot inspection , and weight monitoring , and fewer problems with medication adherence ( all P -0.03 ) . Follow-up Hb A , , levels were 0.3 % lower in the intervention group ( P = 0.1 ) , and about twice as many intervention patients had Hb A1c levels within the normal range ( P = 0.04 ) . Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients ( P = 0.002 ) . Intervention patients also reported better glycemic control ( P = 0.005 ) and fewer diabetic symptoms ( P < 0.0001 ) , including fewer symptoms of hyperglycemia and hypoglycemia . CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control , and for decreasing symptoms among vulnerable patients with diabetes OBJECTIVE To evaluate the effects of insulin 30/70 twice daily or bedtime isophane ( NPH ) insulin plus continued sulfonylurea and metformin in patients with type 2 diabetes in primary care . STUDY DESIGN Open-label , r and omized trial . POPULATION Persons younger than 76 years with type 2 diabetes whose disease had not been controlled with oral hypoglycemic agents alone . A total of 64 insulin-naive patients treated with maximal feasible dosages of sulfonylurea and metformin ( baseline glycosylated hemoglobin [HbA1c]=8.5 % ) were r and omly assigned to insulin monotherapy ( IM group ; n=31 ) or insulin in addition to unchanged oral hypoglycemic medication ( IC group ; n=33 ) for 12 months . Insulin doses were adjusted to obtain fasting glucose < 7.0 mmol/L and postpr and ial glucose < 10.0 mmol/L. OUTCOMES MEASURED Outcome measures included HbA1c , treatment failure , weight , hypoglycemic events and symptoms , satisfaction with treatment , general well-being , and fear of injecting insulin and testing . RESULTS HbA1c improved from 8.3 % to 7.6 % in the IC group , and from 8.8 % to 7.6 % in the IM group ( P = NS ) . The IC group had 24 % treatment failures , compared with 2 % in the IM group ( P=.09 ) . Patients in the IC group had less weight gain than those in the IM group ( 1.3 vs 4.2 kg ; P=.01 ) , and they reported fewer hypoglycemic events ( 2.7 vs 4.3 ; P=.02 ) . Increased satisfaction with treatment was equal in the 2 groups , and general well-being improved by 3.0 points more in the IC group ( P=.05 ) . Fear of self-injecting and self-testing did not differ . CONCLUSIONS Bedtime NPH insulin added to maximal therapy with sulfonylurea and metformin is an effective , simple , well-tolerated approach for patients with uncontrolled type 2 diabetes Effects of a cognitive behavioural treatment ( CBT ) in type 2 diabetes patients were studied in a r and omised controlled trial . Patients were recruited from a diabetes care system ( DCS ) . The intervention group ( n = 76 )  received managed care from the DCS and CBT .  The control group ( n = 78 )  received managed care only .  Effects on risk of developing coronary heart disease ( CHD ) , clinical characteristics , lifestyle , determinants of behaviour change , quality of life , and depression were assessed after 6 and 12 months . The intervention did not result in a significant reduction of CHD risk ( difference between intervention and control group was −0.32 % ( 95 % CI : −2.27 ; 1.63 ) . The amount of heavy physical activity increased significantly in the intervention group at 6 months [ intervention versus control group was 20.14 min/day ( 95 % CI : 4.6 ; 35.70 ) ] . Quality of life and level of depression improved as well . All effects disappeared after 6 months . No effects were found on clinical characteristics BACKGROUND Increased emphasis is being placed on the critical need to control hypertension ( HTN ) in patients with diabetes . OBJECTIVE The objective of this study was to evaluate the efficacy of a nurse-managed home telehealth intervention to improve outcomes in veterans with comorbid diabetes and HTN . DESIGN A single-center , r and omized , controlled clinical trial design comparing two remote monitoring intensity levels and usual care in patients with type 2 diabetes and HTN being treated in primary care was used . MEASUREMENTS Primary outcomes were hemoglobin A1c and systolic blood pressure ( SBP ) ; secondary outcome was adherence . RESULTS Intervention subjects experienced decreased A1c during the 6-month intervention period compared with the control group , but 6 months after the intervention was withdrawn , the intervention groups were comparable with the control group . For SBP , the high-intensity subjects had a significant decrease in SBP compared with the other groups at 6 months and this pattern was maintained at 12 months . Adherence improved over time for all groups , but there were no differences among the three groups . LIMITATIONS Subjects had relatively good baseline control for A1c and SBP ; minorities and women were underrepresented . CONCLUSIONS Home telehealth provides an innovative and pragmatic approach to enhance earlier detection of key clinical symptoms requiring intervention . Transmission of education and advice to the patient on an ongoing basis with close surveillance by nurses can improve clinical outcomes in patients with comorbid chronic illness 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 OBJECTIVE To study differences in diabetes-related parameters in type 2 diabetic patients treated with the support of a Diabetes Service compared to conventional general practice care . DESIGN Parallel clinical trial with r and omisation at practice level . SETTING Fifteen general practice s. PATIENTS Type 2 diabetic patients , aged < 76 years , treated by a GP . MAIN OUTCOME MEASURES Level of glycated haemoglobin ( HbA1c ) . RESULTS 246 patients entered the study .  Final mean HbA1c of all evaluable patients allocated to the intervention ( n = 84 ) was 7.1+/-1.2 % , vs 7.5+/-1.8 % in the controls ( n = 140 ) ( p = 0.06 ) . Patients who were initially poorly controlled ( Fasting Blood Glucose > 10 mmol/l ) had a significantly lower final HbA1c if they were in an intervention practice ( p=0.001 ) . Fewer patients in intervention practice s were referred to hospital specialists ( 1 vs 14 ) . CONCLUSIONS Support by the Dutch Diabetes Service did not significantly influence glycated haemoglobin . The subgroup of initially poorly controlled patients developed a significantly lower HbA1c in intervention practice s ( supported by a Diabetes Service ) than in control practice 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 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 We examine whether one-to-one lifestyle counseling for non-insulin-treated diabetic out patients by a Certified Expert Nurse ( CEN ) can improve patients ' health outcomes . Participants were r and omly assigned to a 1-year lifestyle intervention ( n=67 ) or to a usual care group ( n=67 ) . Main outcome measures were changes from baseline in : HbA(1C ) and score of health related quality of life scales ( SF-36 and Problem Areas in Diabetes Scale ) . Cognitive/behavioral modification for 1 year and satisfaction in CEN counseling was also measured by self-produced items . We found no significant differences in HbA(1C ) , BMI , blood pressure , serum lipids , or health related quality of life over 1 year between the two groups . Patients in the intervention group , however , showed modest but more favorable modification of cognition ( p=0.004 ) and behavior ( p<0.001 ) than subjects in usual care group . The low attrition rate ( 9 % ) , more frequent hospital visit ( 12+/-2 times versus 11+/-3 times ; p=0.03 ) and high degree of satisfaction ( 95 % ) in the intervention group indicate feasibility of the monthly CEN counseling in the outpatient setting s of Japanese hospitals . Future research should confirm the long-term effectiveness of the CEN counseling on clinical outcomes and the cost effectiveness of a possibly time-consuming intervention Background This dual‐center , r and omized controlled trial aim ed to compare 2 types of intra‐abdominal drains after pancreatic resection and their effect on the development of pancreatic fistulae and postoperative complications . Methods Patients undergoing pancreatic resection were r and omized to receive either a closed‐suction drain or a closed , passive gravity drain . The primary endpoint was the rate of postoperative pancreatic fistula . A secondary endpoint was postoperative morbidity during follow‐up of 3 months . The planned sample size was 223 patients . Results A total of 294 patients were assessed for eligibility , 223 of whom were r and omly allocated . One patient was lost during follow‐up , and 111 patients in each group were analyzed . The rate of postoperative pancreatic fistula ( closed‐suction 43.2 % , passive 36.9 % , P = .47 ) and overall morbidity  ( closed‐suction 51.4 % , passive 40.5 % , P = .43 ) were not different between the groups . We did not find any differences between the groups in reoperation rate ( P = .45 ) , readmission rate ( P = .27 ) , hospital stay ( P = .68 ) , or postoperative hemorrhage ( P = .11 ) . We found a significantly lesser amount of drain fluid in the passive gravity drains between the second and fifth postoperative days and also on the day of drain removal compared with closed‐suction drains . Conclusion The type of drain ( passive versus closed suction ) had no influence on the rate of postoperative pancreatic fistulae .  The closed‐suction drains did not increase the rate of postoperative complications . We found that the passive gravity drains are more at risk for obstruction , whereas the closed‐suction drains kept their patency for greater duration
target: Conclusions The available evidence suggests that diabetes self-management education can reduce all-cause mortality risk in type 2 diabetes patients .
background: Background Diabetes self-management education is an essential part of diabetes care , but its impact on all-cause mortality risk of type 2 diabetes patients is unclear .
  A systematic review and meta- analysis aim ing to eluci date the impact of diabetes self-management education on all-cause mortality risk of type 2 diabetes patients was performed .