An office-based intervention to maintain parent-adolescent teamwork in diabetes management. Impact on parent involvement, family conflict, and subsequent glycemic control.

OBJECTIVE: To design and evaluate an office-based intervention aimed at maintaining parent-adolescent teamwork in diabetes management tasks without increasing diabetes-related family conflict. RESEARCH DESIGN AND METHODS: There were 85 patients (aged 10-15 years, mean 12.6 years) with type 1 diabetes (mean duration 5.5 years; mean HbA1c 8.5%) who were randomly assigned to one of three study groups--teamwork, attention control, and standard care--and followed for 24 months. At each visit, parent involvement in insulin administration and blood glucose monitoring was assessed. The teamwork and attention control interventions were integrated into routine ambulatory visits over the first 12 months (four medical visits). Measures of diabetes-related family conflict were collected at baseline and after 12 months. All patients were followed for an additional 12 months with respect to glycemic control. RESULTS: In the teamwork group, there was no major deterioration (0%) in parent involvement in insulin administration, in contrast to 16% major deterioration in the combined comparison (attention control and standard care) group (P < 0.03). Similarly, no teamwork families showed major deterioration in parent involvement with blood glucose monitoring versus 11% in the comparison group (P < 0.07). On both the Diabetes Family Conflict Scale and the Diabetes Family Behavior Checklist, teamwork families reported significantly less conflict at 12 months. An analysis of HbA1c over the 12- to 24-month follow-up period indicated that more adolescents in the teamwork group (68%) than in the comparison group (47%) improved their HbA1c (P < 0.07). CONCLUSIONS: The data demonstrate that parent involvement in diabetes management tasks can be strengthened through a low-intensity intervention integrated into routine follow-up diabetes care. Moreover, despite increased engagement between teen and parent centered around diabetes tasks, the teamwork families showed decreased diabetes-related family conflict. Within the context of a broader cultural recognition of the protective function of parent involvement in the lives of adolescents, the findings of this study reinforce the potential value of a parent-adolescent partnership in managing chronic disease.     

Continuous subcutaneous insulin infusion. A new way to lower risk of severe hypoglycemia, improve metabolic control, and enhance coping in adolescents with type 1 diabetes.

OBJECTIVE: Recommendations from the Diabetes Control and Complications Trial (DCCT) indicate that adolescents with type 1 diabetes should be treated with intensive therapy involving multiple daily injections (MDI) of insulin or insulin pump therapy (continuous subcutaneous insulin infusion [CSII] to help obtain better metabolic control and prevent later complications. Interest has thus focused on insulin pump therapy to help adolescents meet this challenge. The purpose of this study was to examine responses to CSII and MDI in a large group of adolescents with established type 1 diabetes during a 12-month period and to determine whether either treatment regimen more favorably affected clinical and psychosocial outcomes. RESEARCH DESIGN AND METHODS: One-third of 75 youths aged 12-20 years who were candidates for intensive therapy chose CSII as their mode of treatment. Patients received intensive treatment and education as described by the DCCT investigators. Psychosocial data (e.g., quality of life, depression, self-efficacy, and coping) were collected at baseline and at 6-month intervals, and clinical data (e.g., HbA1c levels, adverse events) were collected every 4-6 weeks. RESULTS: Although both MDI- and CSII-treated adolescents initially exhibited improved metabolic control, this level of control was more difficult to sustain for 12 months in the MDI group (at 6 months HbA1c = 8.1, at 12 months HbA1c = 8.3), whereas average HbA1c levels in the CSII group continued to decrease during the 12 months of treatment (at 6 months HbA1c = 7.7, at 12 months HbA1c = 7.5). Despite lower HbA1c levels in CSII-versus MDI-treated patients, the rate of severe hypoglycemic events was reduced by almost 50% in the CSII group (P = 0.01). Self-reported questionnaires demonstrated that there was improvement in self-efficacy, depression, and quality of life in both MDI- and CSII-treated patients. Finally, adolescents using CSII found coping with diabetes to be less difficult than adolescents using MDI did. CONCLUSIONS: CSII is an alternative means to lower HbA1c levels and reduce the risk of hypoglycemia without adversely affecting psychosocial outcomes in adolescents with type 1 diabetes.     

Diabetes management in a health maintenance organization. Efficacy of care management using cluster visits

OBJECTIVE: To evaluate the effectiveness of a cluster visit model led by a diabetes nurse educator for delivering outpatient care management to adult patients with poorly controlled diabetes. RESEARCH DESIGN AND METHODS: This study involved a randomized controlled trial among patients of Kaiser Permanente's Pleasanton, CA, center who were aged 16-75 years and had either poor glycemic control (HbA1c > 8.5%) or no HbA1c test performed during the previous year. Intervention subjects received multidisciplinary outpatient diabetes care management delivered by a diabetes nurse educator, a psychologist, a nutritionist, and a pharmacist in cluster visit settings of 10-18 patients/month for 6 months. Outcomes included change (from baseline) in HbA1c levels; self-reported changes in self-care practices, self-efficacy, and satisfaction; and utilization of inpatient and outpatient health care. RESULTS: After the intervention, HbA1c levels declined by 1.3% in the intervention subjects versus 0.2% in the control subjects (P < 0.0001). Several self-care practices and several measures of self-efficacy improved significantly in the intervention group. Satisfaction with the program was high. Both hospital (P = 0.04) and outpatient (P < 0.01) utilization were significantly lower for intervention subjects after the program. CONCLUSIONS: A 6-month cluster visit group model of care for adults with diabetes improved glycemic control, self-efficacy, and patient satisfaction and resulted in a reduction in health care utilization after the program.     

Culturally competent diabetes self-management education for Mexican Americans: the Starr County border health initiative

OBJECTIVE: To determine the effects of a culturally competent diabetes self-management intervention in Mexican Americans with type 2 diabetes. RESEARCH DESIGN AND METHODS: A prospective, randomized, repeated measures study was conducted on the Texas-Mexico border in Starr County. A total of 256 randomly selected individuals with type 2 diabetes between 35 and 70 years of age, diagnosed with type 2 diabetes after 35 years of age, and accompanied by a family member or friend were included. The intervention consisted of 52 contact hours over 12 months and was provided by bilingual Mexican American nurses, dietitians, and community workers. The intervention involved 3 months of weekly instructional sessions on nutrition, self-monitoring of blood glucose, exercise, and other self-care topics and 6 months of biweekly support group sessions to promote behavior changes. The approach was culturally competent in terms of language, diet, social emphasis, family participation, and incorporation of cultural health beliefs. Outcomes included indicators of metabolic control (HbA(1c) and fasting blood glucose), diabetes knowledge, and diabetes-related health beliefs. RESULTS: Experimental groups showed significantly lower levels of HbA(1c) and fasting blood glucose at 6 and 12 months and higher diabetes knowledge scores. At 6 months, the mean HbA(1c) of the experimental subjects was 1.4% below the mean of the control group; however, the mean level of the experimental subjects was still high (>10%). CONCLUSIONS: This study confirms the effectiveness of culturally competent diabetes self-management education on improving health outcomes of Mexican Americans, particularly for those individuals with HbA(1c) levels >10%.     

Strong in body and spirit: lifestyle intervention for Native American adults with diabetes in New Mexico.

OBJECTIVE: To determine the effects of a culturally appropriate diabetes lifestyle intervention for Native Americans on risk factors for complications of diabetes. RESEARCH DESIGN AND METHODS: A nonrandomized, community-based diabetes intervention trial was conducted in three Native American sites in New Mexico from 1993-1997. Participants were assigned to intervention or control based on community of residence. Intervention sessions were held approximately 6 weeks apart over approximately 10 months. The intervention was delivered in site A in family and friends (FF) groups (n = 32); site B received the same intervention in one-on-one (OO) appointments (n = 39); and site C received usual medical care (UC) (n = 33) (total participants, n = 104). Primary change in HbA(1c) level was assessed at 1 year. RESULTS: Adjusted mean change in HbA(1c) value varied significantly across the three arms at 1 year (P = 0.05). The UC arm showed a statistically significant increase in adjusted mean HbA(1c) change (1.2%, P = 0.001), whereas both intervention arms showed a small nonsignificant (P > 0.05) increase in the adjusted mean change (0.5% and 0.2% for FF and OO arms, respectively). The increase was statistically significantly smaller in the combined intervention arms (0.4%) compared with the UC arm (1.2%, P = 0.02). CONCLUSIONS: Lifestyle intervention has the potential to substantially reduce microvascular complications, mortality, and health care utilization and costs if the change is sustained over time.     

Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system

OBJECTIVE: To investigate the long-term effectiveness of the Internet-based glucose monitoring system (IBGMS) on glucose control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: We conducted a prospective, randomized, controlled trial in 80 patients with type 2 diabetes for 30 months. The intervention group was treated with the IBGMS, while the control group made conventional office visits only. HbA1c (A1C) was performed at 3-month intervals. For measuring of the stability of glucose control, the SD value of A1C levels for each subject was used as the A1C fluctuation index (HFI). RESULTS: The mean A1C and HFI were significantly lower in the intervention group (n = 40) than in the control group (n = 40). (A1C [mean +/- SD] 6.9 +/- 0.9 vs. 7.5 +/- 1.0%, P = 0.009; HFI 0.47 +/- 0.23 vs. 0.78 +/- 0.51, P = 0.001; intervention versus control groups, respectively). Patients in the intervention group with a basal A1C >or=7% (n = 27) had markedly lower A1C levels than corresponding patients in the control group during the first 3 months and maintained more stable levels throughout the study (P = 0.022). Control patients with a basal A1C <7% (n = 15) showed the characteristic bimodal distribution of A1C levels, whereas the A1C levels in the intervention group remained stable throughout the study with low HFI. CONCLUSIONS: Long-term use of the IBGMS has proven to be superior to conventional diabetes care systems based on office visits for controlling blood glucose and achieving glucose stability.     

Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis

OBJECTIVE: To determine the efficacy of telecare (modem transmission of glucometer data and clinician feedback) to support intensive insulin therapy in patients with type 1 diabetes and inadequate glycemic control. RESEARCH DESIGN AND METHODS: Thirty-one patients with type 1 diabetes on intensive insulin therapy and with HbA1c >7.8% were randomized to telecare (glucometer transmission with feedback) or control (glucometer transmission without feedback) for 6 months. The primary end point was 6-month HbA1c. To place our findings in context, we pooled HbA1c change from baseline reported in randomized trials of telecare identified in a systematic review of the literature. RESULTS: Compared with the control group, telecare patients had a significantly lower 6-month HbA1c (8.2 vs. 7.8%, P = 0.03, after accounting for HbA1c at baseline) and a nonsignificant fourfold greater chance of achieving 6-month HbA1c < or =7% (29 vs. 7%; risk difference 21.9%, 95% CI -4.7 to 50.5). Nurses spent 50 more min/patient giving feedback on the phone with telecare patients than with control patients. Meta-analysis of seven randomized trials of adult patients with type 1 diabetes found a 0.4% difference (95% CI 0-0.8) in HbA1c mean change from baseline between the telecare and control groups. CONCLUSIONS: Telecare is associated with small effects on glycemic control in patients with type 1 diabetes on intensive insulin therapy but with inadequate glycemic control.     

Impact of computer-generated personalized goals on HbA(1c).

OBJECTIVE: The public is increasingly aware of the importance of HbA(1c) testing, yet the vast majority of patients with diabetes do not know their HbA(1c) status or goal. We set forth to evaluate the impact of a system that provides uniquely formatted and personalized reports of diabetes status and goals on changes in HbA(1c) levels. RESEARCH DESIGN AND METHODS: A total of 150 patients with diabetes were randomized to receive either standard care or intervention inclusive of a computer-generated 11" x 17" color poster depicting an individual's HbA(1c) status and goals along with personalized steps to aid in goal achievement. All patients enrolled received diabetes education during the 3 months before enrollment. HbA(1c) was performed at baseline and 6 months. RESULTS: At baseline, there were no significant differences between patient groups in terms of age, sex, education level, race, and HbA(1c) or lipid levels. Among patients with baseline HbA(1c) > or =7.0%, there was an 8.6% (0.77% absolute) reduction in HbA(1c) among control subjects compared with a 17.0% (1.69% absolute) decline in the intervention group (P = 0.032). There were no differences between the control and intervention groups with respect to the frequency of patients experiencing any decline in HbA(1c) (63 vs. 69%, P = 0.87); among these patients experiencing a decline, the most substantial reductions were seen with the control group, which had a 13.3% (1.15% absolute) decline compared with the intervention patients, who reduced their HbA(1c) by 24.2% (2.26% absolute reduction; P = 0.0048). At study close, 77% of the patients had their poster displayed on their refrigerator. CONCLUSIONS: This unique and personalized computer-generated intervention resulted in HbA(1c) lowering comparable to that of hypoglycemic agents.     

基于互联网的糖尿病专科护理在2型糖尿病患者中应用的卫生经济学研究

目的 探讨基于互联网的专科护理在2型糖尿病人群中应用的卫生经济学效益。方法 根据纳入及排除标准,选取门诊2型糖尿病患者为研究对象,随机分为对照组（n=25）与干预组（n=30）。相比较于对照组,干预组除常规护理外,同时用糖尿病居家护理平台进行管理。基线和干预12个月后,收集患者的一般社会人口学特征、空腹血糖(FPG)、餐后2小时血糖(2hPBG)、糖化血红蛋白(HbA1c)及医疗费用等,进行成本效果分析、成本-效用分析及敏感度分析等统计学处理。结果 12个月后,干预组与对照组FPG、2hPBG及HbA1c均降低（P<0.05）,干预组FPG、2hPBG及HbA1c低于对照组（P<0.05）。干预组降低1mmol/LFPG、降低1mmol/L2hPBG及降低1%HbA1c需分别花费2253.45元、1233.02元、1445.80元;对照组则为5809.49元、2275.88元、1512.06元。结论 基于互联网的糖尿病专科护理可改善2型糖尿病患者血糖控制水平,具有较好的卫生经济学效益。     

Effect of Culturally Tailored Diabetes Education in Ethnic Minorities With Type 2 Diabetes: A Meta-analysis

BACKGROUND:: Diabetes is a major cause of cardiovascular morbidity and mortality. Ethnic minorities experience a disproportionate burden of diabetes; however, few studies have critically analyzed the effectiveness of a culturally tailored diabetes intervention for these minorities. OBJECTIVE:: The aim of this study was to evaluate the effectiveness of a culturally tailored diabetes educational intervention (CTDEI) on glycemic control in ethnic minorities with type 2 diabetes. METHOD:: We searched databases within PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Education Resources Information Center (ERIC), PsycINFO, and ProQuest for randomized controlled trials (RCTs). We performed a meta-analysis for the effect of diabetes educational intervention on glycemic control using glycosylated hemoglobin (HbA1c) value in ethnic minority groups with type 2 diabetes. We calculated the effect size (ES) with HbA1c change from baseline to follow-up between control and treatment groups. RESULTS:: The 12 studies yielded 1495 participants with a mean age of 63.6 years and a mean of 68% female participants. Most studies (84%) used either group education sessions or a combination of group sessions and individual patient counseling. The duration of interventions ranged from 1 session to 12 months. The pooled ES of glycemic control in RCTs with CTDEI was -0.29 (95% confidence interval, -0.46 to -0.13) at last follow-up, indicating that ethnic minorities benefit more from CTDEI when compared with the usual care. The effect of intervention was greatest and significant when HbA1c level was measured at 6 months (ES, -0.41; 95% confidence interval, -0.61 to -0.21). The ES also differed by each participant's baseline HbA1c level, with lower baseline levels associated with higher ESs. CONCLUSIONS:: Based on this meta-analysis, CTDEI is effective for improving glycemic control among ethnic minorities. The magnitude of effect varies based on the settings of intervention, baseline HbA1c level, and time of HbA1c measurement. More rigorous RCTs that examine tailored diabetes education, ethnically matched educators, and more diverse ethnic minority groups are needed to reduce health disparities in diabetes care.     

Home-based resistance training is not sufficient to maintain improved glycemic control following supervised training in older individuals with type 2 diabetes

OBJECTIVE: To examine whether improvements in glycemic control and body composition resulting from 6 months of supervised high-intensity progressive resistance training could be maintained after an additional 6 months of home-based resistance training. RESEARCH DESIGN AND METHODS: We performed a 12-month randomized controlled trial in 36 sedentary, overweight men and women with type 2 diabetes (aged 60-80 years) who were randomly assigned to moderate weight loss plus high-intensity progressive resistance training (RT&WL group) or moderate weight loss plus a control program (WL group). Supervised gymnasium-based training for 6 months was followed by an additional 6 months of home-based training. Glycemic control (HbA1c), body composition, muscle strength, and metabolic syndrome abnormalities were assessed at 0, 3, 6, 9, and 12 months. RESULTS: Compared with the WL group, HbA1c decreased significantly more in the RT&WL group (-0.8%) during 6 months of supervised gymnasium-based training; however, this effect was not maintained after an additional 6 months of home-based training. In contrast, the greater increase in lean body mass (LBM) observed in the RT&WL group compared with the WL group (0.9 kg, P < 0.05) after the gymnasium-based training tended to be maintained after the home-based training (0.8 kg, P = 0.08). Similarly, the gymnasium-based increases in upper body and lower body muscle strength in the RT&WL group were maintained over the 12 months (P < 0.001). There were no between-group differences for changes in body weight, fat mass, fasting glucose, or insulin at 6 or 12 months. CONCLUSIONS: In older adults with type 2 diabetes, home-based progressive resistance training was effective for maintaining the gymnasium-based improvements in muscle strength and LBM but not glycemic control. Reductions in adherence and exercise training volume and intensity seem to impede the effectiveness of home-based training for maintaining improved glycemic control.     

Implementing practice guidelines for diabetes care using problem-based learning. A prospective controlled trial using firm systems.

OBJECTIVE: A controlled trial with 15-month follow-up was conducted in two outpatient clinics to study the effects of using the problem-based learning technique to implement a diabetes clinical practice guideline. RESEARCH DESIGN AND METHODS: A total of 144 patients with type 2 diabetes aged 25-65 years in two internal medicine outpatient clinics were enrolled in the study. African-Americans and Hispanics made up > 75% of the patients. Doctors and staff in one of the clinics were trained in the use of a clinical practice guideline based on Staged Diabetes Management. A problem-based learning educational program was instituted to reach consensus on a stepped intensification scheme for glycemic control and to determine the standards of care used in the clinic. HbA1c was obtained at baseline and at 9 and 15 months after enrollment. RESULTS: At 9 months, there was a mean -0.90% within-subject change in HbA1c in the intervention group, with no significant changes in the control group. The 15-month mean within-subject change in HbA1c of -0.62% in the intervention group was also significant. Among intervention patients, those with the poorest glycemic control at baseline realized the greatest benefit in improvement of HbA1c. The intervention group also exhibited significant changes in physician adherence with American Diabetes Association standards of care. CONCLUSIONS: Clinical practice guidelines are an effective way of improving the processes and outcomes of care for patients with diabetes. Problem-based learning is a useful strategy to gain physician support for clinical practice guidelines. More intensive interventions are needed to maintain treatment gains.     

Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients.

OBJECTIVE: Accurate and reliable HbA1c results can be obtained at the time of the office visit by using benchtop analyzers. We tested the hypothesis that immediately available HbA1c results could improve glycemic control by changing physician or patient behavior or both. RESEARCH DESIGN AND METHODS: A randomized controlled trial was conducted in 201 type 1 and insulin-treated type 2 diabetic patients attending an academic diabetes center. HbA1c levels, changes in insulin therapy, and use of health care resources were assessed during a 12-month follow-up period. RESULTS: HbA1c levels decreased significantly at 6 and 12 months in the immediate assay group (-0.57 +/- 1.44 and -0.40 +/- 1.65%, respectively; P < 0.01) but did not change in the control group (-0.11 +/- 0.79 and -0.19 +/- 1.16%, respectively; NS). The changes were similar for both type 1 and type 2 diabetic patients. There were no differences in the rates of hypoglycemic events or use of health care resources. CONCLUSIONS: In the setting of a controlled randomized trial, the immediate feedback of HbA1c results at the time of patient encounters resulted in a significant improvement of glycemic control at 6-month follow-up and persisted for the 12-month study. The introduction of this assay was positively received by both patients and physicians.     

Effect of a pharmaceutical care program on vascular risk factors in type 2 diabetes: the Fremantle Diabetes Study

OBJECTIVE: To examine the effect of a 12-month pharmaceutical care (PC) program on vascular risk in type 2 diabetes. RESEARCH DESIGN AND METHODS: We recruited 198 community-based patients randomized to PC or usual care. PC patients had face-to-face goal-directed medication and lifestyle counseling at baseline and at 6 and 12 months plus 6-weekly telephone assessments and provision of other educational material. Clinical, biochemical, and medication-related data were sent regularly to each patient's physician(s). The main outcome measure was change in HbA(1c). A diabetes-specific risk engine was used to estimate changes in 10-year coronary heart disease (CHD) and stroke risk in patients without a history of cardiovascular disease. RESULTS: At total of 180 patients (91%) completed the study. Mean (95% CI) reductions were greater in PC case subjects (n = 92) than control subjects (n = 88) for HbA(1c) (-0.5% [95% CI -0.7 to -0.3] vs. 0 [-0.2 to 0.2]) and systolic (-14 mmHg [-19 to -9] vs. -7 [-11 to -2]) and diastolic (-5 mmHg [-8 to -3] vs. -2 [-4 to 1]) blood pressure (P < or = 0.043). The improvement in HbA(1c) persisted after adjustment for baseline value and demographic and treatment-specific variables. The median (interquartile range) 10-year estimated risk of a first CHD event decreased in the PC case subjects (25.1% [15.6-36.2] to 20.3 [14.6-30.2]; n = 42, P = 0.002) but not in the control subjects (26.1% [17.2-39.4] vs. 26.4 [16.7-38.0]; n = 52, P = 0.17). CONCLUSIONS: A 12-month PC program in type 2 diabetes reduced glycemia and blood pressure. Pharmacist involvement contributed to improvement in HbA(1c) independently of pharmacotherapeutic changes. PC could prove a valuable component of community-based multidisciplinary diabetes care.     

Assessment of group versus individual diabetes education: a randomized study

OBJECTIVES: The current study was conducted to compare the effectiveness of delivering diabetes education in either a group or individual setting using a consistent, evidence-based curriculum. RESEARCH DESIGN AND METHODS: A total of 170 subjects with type 2 diabetes were randomly assigned to either group (n = 87) or individual (n = 83) educational settings. Subjects received education in four sequential sessions delivered at consistent time intervals over a 6-month period. Outcomes included changes in knowledge, self-management behaviors, weight, BMI, HbA(1c), health-related quality of life, patient attitudes, and medication regimen. Changes were assessed at baseline and after the 2-week, 3-month, and 6-month education sessions. RESULTS: Both educational settings had similar improvements in knowledge, BMI, health-related quality of life, attitudes, and all other measured indicators. HbA(1c) decreased from 8.5 +/- 1.8% at baseline to 6.5 +/- 0.8% at 6 months (P < 0.01) in the study population as a whole. Subjects assigned to the individual setting had a 1.7 +/- 1.9% reduction in HbA(1c) (P < 0.01), whereas subjects assigned to the group setting had a 2.5 +/- 1.8% reduction in HbA(1c) (P < 0.01). The difference in HbA(1c) improvement was marginally greater in subjects assigned to group education versus individualized education (P = 0.05). CONCLUSIONS: This study demonstrates that diabetes education delivered in a group setting, when compared with an individual setting, was equally effective at providing equivalent or slightly greater improvements in glycemic control. Group diabetes education was similarly effective in delivering key educational components and may allow for more efficient and cost-effective methods in the delivery of diabetes education programs.     

Safety and effectiveness of insulin pump therapy in children and adolescents with type 1 diabetes

OBJECTIVE: To evaluate the safety and effectiveness of insulin pump therapy in children and adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS: All 95 patients who began insulin pump therapy at Johns Hopkins Hospital between January 1990 and December 2000 were included in the study. The mean age was 12.0 years (range 4-18), and 29% of the patients were <10 years old. Data were obtained by chart review beginning 6-12 months before pump start. The median duration of follow-up was 28 months. RESULTS: There was a small but significant decrease in HbA(1c) at 3-6 months after pump start (7.7 vs. 7.5%; P = 0.03). HbA(1c) levels then gradually increased and remained elevated after 1 year of follow-up; however, this association was confounded by age and diabetes duration, both of which were associated with higher HbA(1c) levels. After adjusting for duration and age, mean HbA(1c) after pump start was significantly lower than before pump start (7.7 vs. 8.1%; P < 0.001). The number of medical complications (diabetic ketoacidosis, emergency department visits) was similar before and after pump start. There were fewer hypoglycemic events after pump start (12 vs. 17, rate ratio 0.46, 95% CI 0.21-1.01). CONCLUSIONS: This study suggests that pump therapy is safe and effective in selected children and adolescents with type 1 diabetes.     

Generalizability and persistence of a multifaceted intervention for improving quality of care for rural patients with type 2 diabetes

OBJECTIVE: Most quality improvement efforts for type 2 diabetes have neglected cardiovascular risk factors and are limited by a lack of information about generalizability across settings or persistence of effect over time. RESEARCH DESIGN AND METHODS: We previously reported 6-month results of a controlled study of an intervention that improved cardiovascular risk factors for rural patients with type 2 diabetes. We subsequently provided the identical intervention to the control region after the main study was completed. The primary outcome was 10% improvement in systolic blood pressure, total cholesterol, or HbA(1c). We compared the previously reported 6-month effect of the original intervention with the effect of the crossed-over intervention to the former control region and remeasured outcomes in the original intervention region 12 months later. RESULTS: Our analysis included 200 original intervention and 181 crossed-over intervention subjects. The age of the population was 62.4 +/- 12.4 years (mean +/- SD), and 54.3% were women. A similar proportion of patients in the crossed-over intervention group achieved improvement in the primary composite outcome compared with the original intervention group (38 vs. 44%, respectively; P = 0.29). In adjusted analyses, we observed less improvement in blood pressure (adjusted odds ratio 0.40 [95% CI 0.17-0.75]) but greater improvements in total cholesterol (1.86 [0.93-3.7]) with the crossed-over intervention compared with the original intervention. We observed sustained improvements in total cholesterol and HbA(1c) levels in the original intervention group, whereas previous large gains in control of blood pressure diminished over time. CONCLUSIONS: We found that our intervention was generalizable across settings, and its effect persisted over time. Nevertheless, without ongoing intervention or reinforcement, we noted some loss of the original benefits that had accrued. Future translational work should incorporate interventions such as ours into ongoing systems of rural care.     

Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial

BackgroundPersistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.MethodsPractical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.ResultsEnrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m².ConclusionsBecause it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.     

Effectiveness of a community pharmacist intervention in diabetes care: a randomized controlled trial

What is known and Objective: There is little evidence from well‐designed randomized controlled trials of the impact of community pharmacist intervention on the clinical management of patients with type 2 diabetes. It is also not known how sustainable any observed effects on glycaemic control are, over time. This study was initiated to address both these issues. Methods: A 6‐month, randomized, controlled parallel‐group trial in 66 community pharmacies was conducted in Belgium. Patients were randomly assigned to receive usual pharmacist care (n = 135) or a predefined pharmacist intervention (n = 153). The intervention mainly focused on correct medication use, medication adherence and healthy lifestyle promotion. Primary outcome was glycaemic control, as measured by fasting plasma glucose and HbA1c. Sustainability of changes in glycaemic control was assessed by additional glucose measurements 18 months after the end of the study. Results and Discussion: The intervention significantly reduced HbA1c (between‐group difference: 0·5%, P = 0.009). The largest impact on HbA1c was observed when pharmacotherapy changes (i.e., type and/or dose of hypoglycaemic agents) initiated by the physician were sustained with pharmaceutical care: HbA1c was reduced by 1·05% in the intervention group, whose medication was changed, compared with a reduction of 0·02% in the therapy‐modification only, group. It was also found that the diabetes education program resulted in improved self‐management and better knowledge of diabetes. Eighteen months after the end of the formal study period, the mean HbA1c of the intervention group did not differ significantly from the control group (7·4% vs. 7·2%). What is new and Conclusion: This study provides new evidence, from a randomized controlled trial, of the beneficial effect of community pharmacist intervention in the clinical management of type 2 diabetic patients. However, questions remain about the sustainability of the observed improvements.