Outcomes of minimal and moderate support versions of an internet-based diabetes self-management support program. Effects of a brief computer-assisted diabetes self-management intervention on dietary, biological and quality-of-life outcomes. Online diabetes self-management program: a randomized study. A randomized, controlled trial of an automated wireless messaging system for diabetes. Brief, computer-assisted diabetes dietary self-management counseling: effects on behavior, physiologic outcomes, and quality of life. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Computer-assisted self-control of diabetes by adolescents. Diabetes self-care knowledge, behaviors, and metabolic control of older adults--the effect of a posteducational follow-up program. The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Meal-related structured self-monitoring of blood glucose: effect on diabetes control in non-insulin-treated type 2 diabetic patients. Diabetes self-management among low-income Spanish-speaking patients: a pilot study. Evaluation of the UCL diabetes self-management programme (UCL-DSMP): a randomized controlled trial. Using telecommunication technology to manage children with diabetes: the Computer-Linked Outpatient Clinic (CLOC) Study. Effect of computer-based learning on diabetes knowledge and control.
Internet and other interactive technology-based programs offer great potential for practical, effective, and cost-efficient diabetes self-management (DSM) programs capable of reaching large numbers of patients. This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program, compared to an enhanced usual care condition.
                A three-arm practical randomized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program, offered in English and Spanish, compared to enhanced usual care. A heterogeneous sample of 463 type 2 patients was randomized and 82.5% completed a 4-month follow-up. Primary outcomes were behavior changes in healthy eating, physical activity, and medication taking. Secondary outcomes included hemoglobin A1c, body mass index, lipids, and blood pressure.
                The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes (effect sizes [d] for healthy eating = 0.32; fat intake = 0.28; physical activity= 0.19) in both intent-to-treat and complete-cases analyses. These changes did not translate into differential improvements in biological outcomes during the 4-month study period. Added contact did not further enhance outcomes beyond the minimal contact intervention.
                The Internet intervention meets several of the RE-AIM criteria for potential public health impact, including reaching a large number of persons, and being practical, feasible, and engaging for participants, but with mixed effectiveness in improving outcomes, and consistent results across different subgroups. Additional research is needed to evaluate longer-term outcomes, enhance effectiveness and cost-effectiveness, and understand the linkages between intervention processes and outcomes. There is a need for practical, efficient and broad-reaching diabetes self-management interventions that can produce changes in lifestyle behaviours such as healthy eating and weight loss. The objective of this study was to evaluate such a computer-assisted intervention.
                Type 2 diabetes primary care patients (n=335) from fee-for-service and health maintenance organization settings were randomized to social cognitive theory-based tailored self-management (TSM) or computer-aided enhanced usual care (UC). Intervention consisted of computer-assisted self-management assessment and feedback, tailored goal-setting, barrier identification, and problem-solving, followed by health counsellor interaction and follow-up calls. Outcomes were changes in dietary behaviours (fat and fruit/vegetable intake), haemoglobin Alc (HbA1c), lipids, weight, quality of life, and depression.
                TSM patients reduced dietary fat intake and weight significantly more than UC patients at the 2-month follow-up. Among patients having elevated levels of HbA1c, lipids or depression at baseline, there were consistent directional trends favouring intervention, but these differences did not reach significance. The intervention proved feasible and was implemented successfully by a variety of staff.
                This relatively low-intensity intervention appealed to a large, generally representative sample of patients, was well implemented, and produced improvement in targeted behaviours. Implications of this practical clinical trial for dissemination are discussed. 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. Aggressive management of blood glucose reduces future diabetes-related complications, but this is difficult to achieve.
                This randomized, controlled study tested the effect of using a wireless two-way pager-based automated messaging system to improve diabetes control through facilitated self-management. The system sent health-related messages to patients, with automatic forwarding of urgent patient responses to the health care team.
                Participants in both the experimental (pager) and the control groups experienced an average hemoglobin A1c decrease of 0.1-0.3%. More patients in the pager group were normotensive, and more felt that their health care was better by the end of the study. A total of 79% of participants enjoyed using the pager, and 68% wanted to continue using the system.
                Utilizing a wireless, automated messaging system in clinical practice is a feasible, low-cost, interactive way to facilitate diabetes self-management, which is acceptable to patients. While providing a convenient way for patients and providers to communicate, this system can support automated recording and ready retrieval of these real-time interactions. 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. To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes.
                A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled and included in analysis. The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period. Secondary outcomes were changes in patient-reported diabetes symptoms, diabetes distress, depression, and other clinical (blood pressure) and laboratory (lipid) values. Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support. Patients received automated, real-time educational and behavioral messaging in response to individually analyzed blood glucose values, diabetes medications, and lifestyle behaviors communicated by mobile phone. Providers received quarterly reports summarizing patient's glycemic control, diabetes medication management, lifestyle behaviors, and evidence-based treatment options.
                The mean declines in glycated hemoglobin were 1.9% in the maximal treatment group and 0.7% in the usual care group, a difference of 1.2% (P < 0.001) over 12 months. Appreciable differences were not observed between groups for patient-reported diabetes distress, depression, diabetes symptoms, or blood pressure and lipid levels (all P > 0.05).
                The combination of behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year. This paper reports an experimental investigation of the microcomputer-based system, Diabetes in Self-Control (DISC), used to facilitate adolescents' self-management of insulin-dependent diabetes mellitus. Twenty 12- to 19-year-old subjects were matched into 10 pairs and randomly assigned to DISC or conventional education (CE). Following a no-treatment phase, information about diabetes and self-monitoring was presented during 7 weeks of phase 2 by means of computer-assisted instruction for the DISC group and printed materials for the CE group. During the 8 weeks of phase 3, DISC subjects received training on monitoring the relationships among variables, diabetes problem solving, and goal setting. Improvement that was both statistically and clinically significant was noted in the DISC group's prelunch and dinner glucose levels. The DISC group showed clinical improvement in frequency of blood glucose testing. Finally, DISC subjects reported more behavioral change as a function of what was learned. Older adults with diabetes experience greater barriers to practicing self-care activities necessary for disease control than their younger counterparts. It was hypothesized that posteducational follow-up intervention would increase self-care knowledge scores, improve metabolic control, and reduce self-care behavioral deficits. Twenty-seven hospitalized elderly patients with diabetes who had completed an inpatient education program were recruited and randomized into experimental (n = 15) and control (n = 12) groups. A posttest on HbA1c and diabetes self-care knowledge (DKN) was administered to all subjects, and self-care behavioral deficits were measured. A four-week follow-up intervention via telephone contact also was administered to the experimental subjects. No significant difference was observed in DKN and HbA1c values. A significant difference was achieved in reduction of self-care behavioral deficits (P < 0.05-0.01). It was concluded that posteducational follow-up is necessary for enhancing self-care adherence and ensuring safe practice of home care for elderly patients with diabetes. A prerequisite to translating research findings into practice is information on consistency of implementation, maintenance of results, and generalization of effects. This follow-up report is one of the few experimental studies to provide such information on Internet-based health education.
                We present follow-up data 10 months following randomization on the "Diabetes Network (D-Net)" Internet-based self-management project, a randomized trial evaluating the incremental effects of adding (1) tailored self-management training or (2) peer support components to a basic Internet-based, information-focused comparison intervention. Participants were 320 adult type 2 diabetes patients from participating primary care offices, mean age 59 (SD = 9.2), who were relatively novice Internet users.
                All intervention components were consistently implemented by staff, but participant website usage decreased over time. All conditions were significantly improved from baseline on behavioral, psychosocial, and some biological outcomes; and there were few differences between conditions. Results were robust across on-line coaches, patient characteristics, and participating clinics.
                The basic D-Net intervention was implemented well and improvements were observed across a variety of patients, interventionists, and clinics. There were, however, difficulties in maintaining usage over time and additions of tailored self-management and peer support components generally did not significantly improve results. Less than 63% of individuals with diabetes meet professional guidelines target of hemoglobin A1c <7.0%, and only 7% meet combined glycemic, lipid, and blood pressure goals. The primary study aim was to assess the impact on A1c of a cell phone-based diabetes management software system used with web-based data analytics and therapy optimization tools. Secondary aims examined health care provider (HCP) adherence to prescribing guidelines and assessed HCPs' adoption of the technology.
                Thirty patients with type 2 diabetes were recruited from three community physician practices for a 3-month study and evenly randomized. The intervention group received cell phone-based software designed by endocrinologists and CDEs (WellDoc Communications, Inc., Baltimore, MD). The software provided real-time feedback on patients' blood glucose levels, displayed patients' medication regimens, incorporated hypo- and hyperglycemia treatment algorithms, and requested additional data needed to evaluate diabetes management. Patient data captured and transferred to secure servers were analyzed by proprietary statistical algorithms. The system sent computer-generated logbooks (with suggested treatment plans) to intervention patients' HCPs.
                The average decrease in A1c for intervention patients was 2.03%, compared to 0.68% (P < 0.02, one-tailed) for control patients. Of the intervention patients, 84% had medications titrated or changed by their HCP compared to controls (23%, P = 0.002). Intervention patients' HCPs reported the system facilitated treatment decisions, provided organized data, and reduced logbook review time.
                Adults with type 2 diabetes using WellDoc's software achieved statistically significant improvements in A1c. HCP and patient satisfaction with the system was clinically and statistically significant. To investigate the effect of meal-related self-monitoring of blood glucose on glycemic control and well-being in non-insulin-treated type 2 diabetic patients.
                This 6-month study, which included 6 months of follow-up, adopted a prospective, multicenter, randomized controlled design. Subjects were randomized to two groups: one group used a blood glucose-monitoring device, kept a blood glucose/eating diary, and received standardized counseling; the control group received nonstandardized counseling on diet and lifestyle. The primary efficacy parameter was the change in HbA(1c). Secondary efficacy variables included changes in body weight, lipids, and microalbumin and changes in treatment satisfaction and well-being.
                In the per-protocol analysis, the use of a self-monitoring blood glucose device significantly reduced HbA(1c) levels by 1.0 +/- 1.08% compared with 0.54 +/- 1.41% for the control group (P = 0.0086); subgroup analysis showed three types of responders. Body weight, total cholesterol, and microalbumin improved when using a glucometer, but there was no statistically significant difference between the two groups. Treatment satisfaction increased in both groups to a similar extent (P = 0.9). Self-monitoring resulted in a marked improvement of general well-being with significant improvements in the subitems depression (P = 0.032) and lack of well-being (P = 0.02).
                Meal-related self-monitoring of blood glucose within a structured counseling program improved glycemic control in the majority of non-insulin-treated type 2 diabetic patients in this study. The finding of three types of responders will be important for future planning of counseling and educational interventions. The prevalence of type 2 diabetes and diabetes-related morbidity and mortality is higher among low-income Hispanics when compared to that of Whites. However, little is known about how to effectively promote self-management in this population.
                The objectives were first to determine the feasibility of conducting a randomized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects.
                Participants for this pilot study were recruited from a community health center, an elder program, and a community-wide database developed by the community health center, in collaboration with other agencies serving the community, by surveying households in the entire community. Participants were randomly assigned to an intervention (n = 15) or a control (n = 10) condition. Assessments were conducted at baseline and at 3 months and 6 months postrandomization. The intervention consisted of 10 group sessions that targeted diabetes knowledge, attitudes, and self-management skills through culturally specific and literacy-sensitive strategies. The intervention used a cognitive-behavioral theoretical framework.
                Recruitment rates at the community health center, elder program, and community registry were 48%, 69%, and 8%, respectively. Completion rates for baseline, 3-month, and 6-month assessments were 100%, 92%, and 92%, respectively. Each intervention participant attended an average of 7.8 out of 10 sessions, and as a group the participants showed high adherence to intervention activities (93% turned in daily logs, and 80% self-monitored glucose levels at least daily). There was an overall Group x Time interaction (p = .02) indicating group differences in glycosylated hemoglobin over time. The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was -0.8% (95% confidence intervals = -1.1%, -0.5%) compared with the change in the control group (p = .02). At 6 months, the decrease in the intervention group remained significant, -0.85% (95% confidence intervals = -1.2, -0.5), and the decrease was still significantly different from that of the controls (p = .005). There was a trend toward increased physical activity in the intervention group as compared to that of the control group (p = .11) and some evidence (nonsignificant) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants. Adjusting for baseline depressive scores, we observed a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment (p = .02).
                Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research. This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a randomized clinical trial. Self-management has been described as the cornerstone of care for diabetes. Many self-management studies are limited by poor methodology and poor descriptions of the intervention. The current study developed a theoretically based self-management programme for patients with type 2 diabetes, which was evaluated via a randomized controlled trial. At immediate post-intervention and three-month follow-up the intervention group showed significant improvement relative to controls on self-management behaviours, quality of life and illness beliefs. A trend towards improved HbA1c was also observed. Documentation in a manual and development of a training programme for facilitators ensures the programme is replicable. The purpose of this study was to evaluate the efficacy of using a telecommunication system to assist in the outpatient management of pediatric patients with insulin-dependent diabetes. Metabolic control, patients' psychosocial status, family functioning, perceived quality of life, patterns of parental/child responsibility for daily diabetes maintenance, and nursing time-on-task were evaluated. One hundred six pediatric patients (mean age = 13.3 years) were randomly assigned to an experimental or control outpatient clinic for 1 year. Experimental subjects transmitted self-monitoring blood glucose data by modem to the hospital every 2 weeks. Transmitted data were reviewed by nurse practitioners who telephoned subjects to discuss regimen adjustments. Control subjects received standard care with regimen adjustments made by physicians. There were no significant between-group differences for metabolic control, rates of hospitalization or emergency-room visits, psychological status, general family functioning, quality of life, or parent-child responsibility. A significant decrease was noted in nursing time-on-task for experimental subjects. Two interactive computer-based systems have been evaluated: a teaching program with text and animated graphics and a multiple-choice knowledge-assessment program (KAP) with optional prescriptive feedback. One hundred seventy-four routine-attending insulin-dependent diabetes mellitus (IDDM) and non-insulin-dependent diabetes mellitus (NIDDM) patients were allocated to active and control groups to determine the effect of these programs on knowledge and control after a 4- to 6-mo follow-up period. Interactive computer teaching (ICT) resulted in a significant knowledge increment in both IDDM and NIDDM patients (P less than .05), together with a mean fall of 0.8 and 0.7%, respectively, in HbA1c (P less than .05 and P greater than .1), but no changes were observed in respective control groups. The KAP with feedback also produced a significant knowledge increment in both IDDM and NIDDM patients (P less than .05), of similar magnitude to the ICT program, and a mean fall in HbA1c of 1.2 and 1.3%, respectively (P less than .05), with no changes in the corresponding control groups. Even when KAP was used without prescriptive feedback, smaller but significant mean falls in HbA1c of 0.7 and 0.8% (P less than .05) were seen in IDDM and NIDDM patients, respectively, suggesting a motivational effect resulting from program participation.(ABSTRACT TRUNCATED AT 250 WORDS)
Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control and the effect was larger in the mobile phone subgroup. There is no evidence to show benefits in other biological outcomes or any cognitive, behavioural or emotional outcomes.