Caring for poorly controlled diabetes mellitus: a randomized pharmacist intervention. Lifestyle intervention according to general recommendations improves glucose tolerance. Effects of lifestyle modifications on patients with type 2 diabetes: the Japan Diabetes Complications Study (JDCS) study design, baseline analysis and three year-interim report. Lifestyle intervention by group care prevents deterioration of Type II diabetes: a 4-year randomized controlled clinical trial. A practical randomized trial to improve diabetes care. Online diabetes self-management program: a randomized study. Use of multisystemic therapy to improve regimen adherence among adolescents with type 1 diabetes in chronic poor metabolic control: a randomized controlled trial. Brief, computer-assisted diabetes dietary self-management counseling: effects on behavior, physiologic outcomes, and quality of life. An intervention to overcome clinical inertia and improve diabetes mellitus control in a primary care setting: Improving Primary Care of African Americans with Diabetes (IPCAAD) 8. An endocrinologist-supported intervention aimed at providers improves diabetes management in a primary care site: improving primary care of African Americans with diabetes (IPCAAD) 7. Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males. Evaluation of a structured teaching and treatment programme for type 2 diabetes in general practice in a rural area of Austria. Randomized effectiveness trial of a computer-assisted intervention to improve diabetes care. Assessment of two culturally competent diabetes education methods: individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes. Integrating type 2 diabetes mellitus and depression treatment among African Americans: a randomized controlled pilot trial.
There is limited information from randomized controlled studies about the influence of pharmacist interventions on diabetes control.
                To evaluate the effect of a pharmacist intervention on improving diabetes control; secondary endpoints were medication appropriateness and self-reported adherence.
                A randomized, controlled, multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics. Seventy-seven subjects, > or =18 years old with a hemoglobin (Hb) A(1c) > or =9% at baseline and taking at least one oral diabetes medication, were randomized 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. HbA(1c), medication appropriateness, and self-reported adherence were assessed at baseline, 6 months, and 12 months.
                The mean HbA(1c) did not differ between groups over the 12-month period (p = 0.61). A reduction in HbA(1c) 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.
                This pharmacist intervention did not significantly improve diabetes control, but did allow for similar HbA(1c) control with fewer physician visits. Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed. Changing dietary and physical activity habits has the potential to postpone or prevent the development of type 2 diabetes. However, it needs to be assessed whether moderate interventions, in agreement with current guidelines for the general population, are effective. We evaluated the impact of a 2-year combined diet and physical activity intervention program on glucose tolerance in Dutch subjects at increased risk for developing diabetes.
                Subjects with glucose intolerance were randomly assigned to either the lifestyle intervention group (INT) or control group (CON). The INT received regular dietary advice and was stimulated to increase their physical activity. The CON received a brief leaflet about healthy diet and increased physical activity. Primary outcome measure was the change in glucose tolerance.
                In total, 88 subjects completed 2 years of intervention (40 subjects in the INT, 48 subjects in the CON, mean BMI 29.4 kg/m2). Subjects in the INT reduced their body weight, waist circumference, and (saturated) fat intake and improved their aerobic capacity. Two-hour plasma glucose concentration declined from 8.7 to 8.0 mM in the INT and rose from 8.6 to 9.4 mM in the CON (p < 0.01). Subjects adherent to both the diet and exercise intervention showed the largest reduction in 2-hour glucose levels.
                Our results showed that a lifestyle intervention program according to general recommendations improves glucose tolerance, even in a less obese and more physical active population. Furthermore, our results underscore the importance of combining diet and physical activity to improve glucose tolerance and insulin resistance. Lifestyle modifications may affect the development of diabetes and prevent complications. However, there is no direct evidence to show that lifestyle intervention is beneficial for patients with established type 2 diabetes.
                The ultimate goal is to determine whether long-term lifestyle intervention can improve glycemic control and prevent complications in patients with type 2 diabetes. This initial report on a multi-year study describes protocols and the analysis of baseline data and three-year interim results.
                The study was a randomized, controlled, multi-centre, prospective intervention trial. The trial included patients from 59 Japanese institutes specializing in diabetes care.
                The study enrolled 2 205 patients with previously diagnosed type 2 diabetes.
                The lifestyle modification program included intensive lifestyle management at each outpatient clinic visit and frequent telephone counseling. The intervention group received educational materials concerning the importance of lifestyle and behavioural changes, a diary to record progress of laboratory and other data, and a pedometer.
                Parameters and indices related to glycemic control, diabetic complications, dyslipidemia, hypertension, obesity, and atherosclerosis were measured several times a year.
                Small but significant differences in HbA1c levels between the intervention (INT) and conventional (CON) therapy groups appeared as early as two years after the start of intervention and were maintained in the third year (CON group, 7.78 +/- 1.27 % vs. INT group, 7.62 +/- 1.20 %, the initial HbA1c level was 7.80 +/- 1.42 % for the CON group and 7.68 +/- 1.28 % for the INT group). Data on differences in occurrence of micro- or macrovascular complications are not yet available.
                The effect of lifestyle modification on improving the glycemic control of patients with established type 2 diabetes mellitus was small but significant three years after initiation of the intervention. Metabolic control worsens progressively in Type II (non-insulin-dependent) diabetes mellitus despite intensified pharmacological treatment and lifestyle intervention, when these are implemented on a one-to-one basis. We compared traditional individual diabetes care with a model in which routine follow-up is managed by interactive group visits while individual consultations are reserved for emerging medical problems and yearly checks for complications.
                A randomized controlled clinical trial of 56 patients with non-insulin-treated Type II diabetes managed by systemic group education and 56 control patients managed by individual consultations and education.
                Observation times were 51.2+/-2.1 months for group care and 51.2+/-1.8 for control subjects. Glycated haemoglobin increased in the control group but not in the group of patients ( p<0.001), in whom BMI decreased ( p<0.001) and HDL-cholesterol increased ( p<0.001). Quality of life, knowledge of diabetes and health behaviours improved with group care ( p<0.001, all) and worsened among the control patients ( p=0.004 to p<0.001). Dosage of hypoglycaemic agents decreased ( p<0.001) and retinopathy progressed less ( p<0.009) among the group care patients than the control subjects. Diastolic blood pressure ( p<0.001) and relative cardiovascular risk ( p<0.05) decreased from baseline in group patients and control patients alike. Over the study period, group care required 196 min and 756.54 US dollars per patient, compared with 150 min and 665.77 US dollars for the control patients, resulting in an additional 2.12 US dollars spent per point gained in the quality of life score.
                Group care by systemic education is feasible in an ordinary diabetes clinic and cost-effective in preventing the deterioration of metabolic control and quality of life in Type II diabetes without increasing pharmacological treatment. There is a well-documented gap between diabetes care guidelines and the services received by patients in almost all health care settings. This project reports initial results from a computer-assisted, patient-centered intervention to improve the level of recommended services received by patients from a wide variety of primary care providers.
                Eight hundred eighty-six patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program. Physicians were stratified and randomized to intervention or control conditions and evaluated on 2 primary outcomes: number of recommended laboratory screenings and recommended patient-centered care activities completed. Secondary outcomes were evaluated using the Problem Areas in Diabetes scale and the Patient Health Questionnaire (PHQ)-9 depression scale, and the RE-AIM framework was used to evaluate potential for dissemination.
                The program was well-implemented and significantly improved both number of recommended laboratory assays (3.4 vs 3.1; P <.001) and patient-centered aspects of diabetes care patients received (3.6 vs 3.2; P <.001) compared to those in randomized control practices. Activities that were increased most were foot exams (follow-up rates of 80% vs 52%; P <.003) and nutrition counseling (76% vs 52%; P <.001).
                Patients are very willing to participate in a brief computer-assisted intervention that is effective in enhancing quality of diabetes care. Staff in primary care offices can consistently deliver an intervention of this nature, but most physicians were unwilling to participate in this translation research study. We hypothesized that people with type 2 diabetes in an online diabetes self-management program, compared with usual-care control subjects, would 1) demonstrate reduced A1C at 6 and 18 months, 2) have fewer symptoms, 3) demonstrate increased exercise, and 4) have improved self-efficacy and patient activation. In addition, participants randomized to listserve reinforcement would have better 18-month outcomes than participants receiving no reinforcement.
                A total of 761 participants were randomized to 1) the program, 2) the program with e-mail reinforcement, or 3) were usual-care control subjects (no treatment). This sample included 110 American Indians/Alaska Natives (AI/ANs). Analyses of covariance models were used at the 6- and 18-month follow-up to compare groups.
                At 6 months, A1C, patient activation, and self-efficacy were improved for program participants compared with usual care control subjects (P < 0.05). There were no changes in other health or behavioral indicators. The AI/AN program participants demonstrated improvements in health distress and activity limitation compared with usual-care control subjects. The subgroup with initial A1C >7% demonstrated stronger improvement in A1C (P = 0.01). At 18 months, self-efficacy and patient activation were improved for program participants. A1C was not measured. Reinforcement showed no improvement.
                An online diabetes self-management program is acceptable for people with type 2 diabetes. Although the results were mixed they suggest 1) that the program may have beneficial effects in reducing A1C, 2) AI/AN populations can be engaged in and benefit from online interventions, and 3) our follow-up reinforcement appeared to have no value. The aim of this study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, could improve adherence and metabolic control and decrease rates of hospital utilization among adolescents with chronically poorly controlled type 1 diabetes.
                A randomized controlled trial was conducted with 127 adolescents with type 1 diabetes and chronically poor metabolic control (HbA(1c) [A1C] > or =8% for the past year) who received their diabetes care in a children's hospital located in a major Midwestern city. Participants randomly assigned to MST received treatment for approximately 6 months. Data were collected at baseline and at 7 months posttest (i.e., treatment termination). Changes in A1C adherence, as measured by semistructured interviews and blood glucose meters and hospital admissions and emergency department visits, were assessed.
                In intent-to-treat analyses, participation in MST was associated with significant improvements in the frequency of blood glucose testing as assessed by blood glucose meter readings (F[1,125] = 16.75, P = 0.001) and 24-h recall interviews (F[1,125] = 6.70, P = 0.011). Participants in MST also had a decreasing number of inpatient admissions, whereas the number of inpatient admissions increased for control subjects (F[1,125] = 6.25, P = 0.014). Per protocol analyses replicated intent-to-treat analyses but also showed a significant improvement in metabolic control for adolescents receiving MST compared with control subjects (F[1,114] = 4.03, P = 0.047).
                Intensive, home-based psychotherapy improves the frequency of blood glucose testing and metabolic control and decreases inpatient admissions among adolescents with chronically poorly controlled type 1 diabetes. The objective of this work was to evaluate the reach, effectiveness, adoption, and implementation of a brief behavioral dietary intervention and 2 supplemental components of diabetes self-management support: telephone follow-up calls and community resources enhancement.
                This was a 2 x 2 randomized, controlled trial investigating the incremental effects of telephone follow-up and community resources enhancement with 320 adult type 2 diabetes outpatients. METHODS. Key outcomes included behavioral (dietary patterns, fat intake), physiologic (HbA1c, lipids), and quality-of-life/patient satisfaction measures and were collected at baseline and 3- and 6-month follow-up.
                Despite high reach (76% patient participation), excellent adoption (all 12 primary care practices approached participated), and good implementation, there were few outcome differences among treatment conditions. There was significant improvement across conditions in most outcomes in each category at both follow-ups.
                A brief, computer-assisted, dietary goal-setting intervention basic treatment condition was moderately successful in producing dietary improvements but less so in producing biologic or quality-of-life outcomes. Additions of follow-up phone calls or a community resources enhancement component did not produce incremental improvements over this basic intervention. Although clinical trials have shown that proper management of diabetes can improve outcomes, and treatment guidelines are widespread, glycated hemoglobin (HbA1c) levels in the United States are rising. Since process measures are improving, poor glycemic control may reflect the failure of health care providers to intensify diabetes therapy when indicated--clinical inertia. We asked whether interventions aimed at health care provider behavior could overcome this barrier and improve glycemic control.
                In a 3-year trial, 345 internal medicine residents were randomized to be controls or to receive computerized reminders providing patient-specific recommendations at each visit and/or feedback on performance every 2 weeks. When glucose levels exceeded 150 mg/dL (8.33 mmol/L) during visits of 4038 patients, health care provider behavior was characterized as did nothing, did anything (any intensification of therapy), or did enough (if intensification met recommendations).
                At baseline, residents did anything for 35% of visits and did enough for 21% of visits when changes in therapy were indicated, and there were no differences among intervention groups. During the trial, intensification increased most during the first year and then declined. However, intensification increased more in the feedback alone and feedback plus reminders groups than for reminders alone and control groups (P<.001). After 3 years, health care provider behavior in the reminders alone and control groups returned to baseline, whereas improvement with feedback alone and feedback plus reminders groups was sustained: 52% did anything, and 30% did enough (P<.001 for both vs the reminders alone and control groups). Multivariable analysis showed that feedback on performance contributed independently to intensification and that intensification contributed independently to fall in HbA1c (P<.001 for both).
                Feedback on performance given to medical resident primary care providers improved provider behavior and lowered HbA1c levels. Similar approaches may aid health care provider behavior and improve diabetes outcomes in other primary care settings. Management of diabetes is frequently suboptimal in primary care settings, where providers often fail to intensify therapy when glucose levels are high, a problem known as clinical inertia. We asked whether interventions targeting clinical inertia can improve outcomes.
                A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center. We studied all patients (4,138) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were randomized to be control subjects or to receive one of three interventions. Instead of consultative advice, the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient's visit, individual face-to-face feedback on performance for 5 min every 2 weeks, or both.
                Over an average patient follow-up of 15 months within the intervention site, improvements in and final HbA1c (A1C) with feedback + reminders (deltaA1C 0.6%, final A1C 7.46%) were significantly better than control (deltaA1C 0.2%, final A1C 7.84%, P < 0.02); changes were smaller with feedback only and reminders only (P = NS vs. control). Trends were similar but not significant with systolic blood pressure (sBP) and LDL cholesterol. Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP. Over a 2-year period, overall glycemic control improved in the intervention site but did not change in other primary care sites (final A1C 7.5 vs. 8.2%, P < 0.001).
                Feedback on performance aimed at overcoming clinical inertia and given to internal medicine resident primary care providers improves glycemic control. Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care settings. Prevention of type 2 diabetes by intensive lifestyle intervention designed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance (IGT). Male subjects with IGT recruited from health-screening examinees were randomly assigned in a 4:1 ratio to a standard intervention group (control group) and intensive intervention group (intervention group). The final numbers of subjects were 356 and 102, respectively. The subjects in the control group and in the intervention group were advised to maintain body mass index (BMI) of <24.0 kg/m2 and of <22.0 kg/m2, respectively, by diet and exercise. In the intervention group, detailed instructions on lifestyle were repeated every 3-4 months during hospital visits. Diabetes was judged to have developed when two or more consecutive fasting plasma glucose (FPG) values exceeded 140 mg/dl. A 100g oral glucose tolerance test was performed every 6 months to detect improvement of glucose tolerance. The subjects were seen in an ordinary outpatient clinic. The cumulative 4-year incidence of diabetes was 9.3% in the control group, versus 3.0% in the intervention group, and the reduction in risk of diabetes was 67.4% (P < 0.001). Body weight decreased by 0.39 kg in the control group and by 2.18 kg in the intervention group (P < 0.001). The control group was subclassified according to increase and decrease in body weight. The incidence of diabetes was positively correlated with the changes in body weight, and the improvement in glucose tolerance was negatively correlated. Subjects with higher FPG at baseline developed diabetes at a higher rate than those with lower FPG. Higher 2h plasma glucose values and higher BMI values at baseline were also associated with a higher incidence of diabetes, but the differences were not significant. Subjects with a low insulinogenic index (DeltaIRI/DeltaPG 30 min after an oral glucose load) developed diabetes at a significantly higher rate than those with a normal insulinogenic index. Comparison of the BMI data and incidence of diabetes in five diabetes prevention studies by lifestyle intervention revealed a linear correlation between the incidence of diabetes and the BMI values, with the exception of the DaQing Study. However, the slope of the reduction in incidence of diabetes in the intensive intervention groups was steeper than expected simply on the basis of the reduction of BMI, suggesting that the effect of lifestyle intervention cannot be solely ascribed to the body weight reduction. We conclude that lifestyle intervention aimed at achieving ideal body weight in men with IGT is effective and can be conducted in an outpatient clinic setting. The efficacy of a treatment and teaching programme for non-insulin-treated Type 2 diabetic patients in general practice was evaluated in a prospective, controlled study. In a rural area in southern Austria, 53 patients from seven general practices participated in a structured programme (intervention group) and 55 patients from seven general practices without the programme served as the control group. After 6 months the weight reduction in the intervention group was 2.6 kg (1.6-3.7 kg, p < 0.001) and the difference in HbA1c between the groups was 0.92% (0.23-1.61%, p < 0.01) at follow-up. Systolic (-16.6 mmHg) and diastolic (-11.1 mmHg) blood pressure, serum triglycerides (-0.63 mmol I-1), and serum cholesterol (-0.40 mmol I-1) were reduced significantly in the intervention group (p < 0.006). The number of patients with callus formation and poor nail care decreased significantly after participating in the teaching programme (p < 0.001). In the control group no reduction in body weight, metabolic control or in risk factors for diabetic foot complications were observed. Calculated health care costs per patient and year decreased in the intervention group (-33 pounds) and increased in the control group (+ 30 pounds) mainly due to changes in prescription of oral hypoglycaemic agents in both groups. This programme may be an efficient and helpful model to increase overall quality of diabetes care according to the St Vincent Declaration. There is a well-documented gap between diabetes care guidelines and the services received by patients in most health care settings. This report presents 12-month follow-up results from a computer-assisted, patient-centered intervention to improve the level of recommended services patients received from a variety of primary care settings.
                A total of 886 patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program. Physicians were stratified and randomized to intervention or control conditions and evaluated on two primary outcomes: number of recommended laboratory screenings and recommended patient-centered care activities completed from the National Committee on Quality Assurance/American Diabetes Association Provider Recognition Program (PRP). Secondary outcomes were evaluated using the Problem Areas in Diabetes 2 quality of life scale, lipid and HbA1c levels, and the Patient Health Questionnaire-9 depression scale.
                The program was well implemented and significantly improved both the number of laboratory assays and patient-centered aspects of diabetes care patients received compared with those in the control condition. There was overall improvement on secondary outcomes of lipids, HbA1c, quality of life, and depression scores; between-condition differences were not significant.
                Staff in small, mixed-payer primary care offices can consistently implement a patient-centered intervention to improve PRP measures of quality of diabetes care. Alternative explanations for why these process improvements did not lead to improved outcomes, and suggested directions for future research are discussed. To examine the impact of two culturally competent diabetes education methods, individual counselling and individual counselling in conjunction with group education, on nutrition adherence and glycemic control in Portuguese Canadian adults with type 2 diabetes over a three-month period.
                The Diabetes Education Centre is located in the urban multicultural city of Toronto, Ontario, Canada. We used a three-month randomized controlled trial design. Eligible Portuguese-speaking adults with type 2 diabetes were randomly assigned to receive either diabetes education counselling only (control group) or counselling in conjunction with group education (intervention group). Of the 61 patients who completed the study, 36 were in the counselling only and 25 in the counselling with group education intervention. We used a per-protocol analysis to examine the efficacy of the two educational approaches on nutrition adherence and glycemic control; paired t-tests to compare results within groups and analysis of covariance (ACOVA) to compare outcomes between groups adjusting for baseline measures. The Theory of Planned Behaviour was used to describe the behavioural mechanisms that influenced nutrition adherence.
                Attitudes, subjective norms, perceived behaviour control, and intentions towards nutrition adherence, self-reported nutrition adherence and glycemic control significantly improved in both groups, over the three-month study period. Yet, those receiving individual counselling with group education showed greater improvement in all measures with the exception of glycemic control, where no significant difference was found between the two groups at three months.
                Our study findings provide preliminary evidence that culturally competent group education in conjunction with individual counselling may be more efficacious in shaping eating behaviours than individual counselling alone for Canadian Portuguese adults with type 2 diabetes. However, larger longitudinal studies are needed to determine the most efficacious education method to sustain long-term nutrition adherence and glycemic control. The purpose of this study was to examine whether integrating depression treatment into care for type 2 diabetes mellitus among older African Americans improved medication adherence, glycemic control, and depression outcomes.
                Older African Americans prescribed pharmacotherapy for type 2 diabetes mellitus and depression from physicians at a large primary care practice in west Philadelphia were randomly assigned to an integrated care intervention or usual care. Adherence was assessed at baseline, 2, 4, and 6 weeks using the Medication Event Monitoring System to assess adherence. Outcomes assessed at baseline and 12 weeks included standard laboratory tests to measure glycemic control and the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression.
                In all, 58 participants aged 50 to 80 years participated. The proportion of participants who had 80% or greater adherence to an oral hypoglycemic (intervention 62.1% vs usual care 24.1%) and an antidepressant (intervention 62.1% vs usual care 10.3%) was greater in the intervention group in comparison with the usual care group at 6 weeks. Participants in the integrated care intervention had lower levels of glycosylated hemoglobin (intervention 6.7% vs usual care 7.9%) and fewer depressive symptoms (CES-D mean scores: intervention 9.6 vs usual care 16.6) compared with participants in the usual care group at 12 weeks.
                A pilot randomized controlled trial integrating type 2 diabetes mellitus treatment and depression was successful in improving outcomes among older African Americans. Integrated interventions may be more feasible and effective in real-world practices with competing demands for limited resources.
Current efforts to improve or to facilitate adherence of people with type 2 diabetes to treatment recommendations do not show significant effects nor harms. The question whether any intervention enhances adherence to treatment recommendations in type 2 diabetes effectively, thus still remains unanswered.