Dataset Information

Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial.

ABSTRACT:

Background

Connected devices that allow people with diabetes to monitor their blood glucose levels remotely with data visualization have been shown to improve self-care behavior in diabetes management. However, their effectiveness and usability for a low-middle-income, racially diverse population are unknown.

Objective

This study aims to evaluate the effects of remote telemonitoring with team-based management on people with uncontrolled type 2 diabetes.

Design

This was a pragmatic 52-week cluster-randomized controlled study among 11 primary care government practices in Malaysia.

Participants

People with type 2 diabetes aged 18 and above, who had hemoglobin A1c ??7.5% but less than 11.0% within the past 3 months and resided in the state of Selangor.

Intervention

The intervention group received home gluco-telemonitors and transmitted glucose data to a care team who could adjust therapy accordingly. The team also facilitated self-management by supporting participants to improve medication adherence, and encourage healthier lifestyle and use of resources to reduce risk factors. Usual care group received routine healthcare service.

Main measure

The primary outcome was the change in HbA1c at 24 weeks and 52 weeks. Secondary outcomes included change in fasting plasma glucose, blood pressure, lipid levels, health-related quality of life, and diabetes self-efficacy.

Results

A total of 240 participants were recruited in this study. The telemonitoring group reported larger improvements in glycemic control compared with control at the end of study (week 24, -?0.05%; 95% CI -?0.10 to 0.00%) and at follow-up (week 52, -?0.03%; -?0.07 to 0.02%, p?=?0.226). Similarly, no differences in other secondary outcomes were observed, including the number of adverse events and health-related quality of life.

Conclusion

This study indicates that there is limited benefit of replacing telemedicine with the current practice of self-monitoring of blood glucose. Further innovative methods to improve patient engagement in diabetes care are needed.

Trial registration

ClinicalTrials.gov identifier: NCT02466880.

SUBMITTER: Lee JY

PROVIDER: S-EPMC6957608 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial.

Lee Jun Yang JY Chan Carina Ka Yee CKY Chua Siew Siang SS Ng Chirk Jenn CJ Paraidathathu Thomas T Lee Kenneth Kwing Chin KKC Lee Shaun Wen Huey SWH

Journal of general internal medicine 20190911 1

<h4>Background</h4>Connected devices that allow people with diabetes to monitor their blood glucose levels remotely with data visualization have been shown to improve self-care behavior in diabetes management. However, their effectiveness and usability for a low-middle-income, racially diverse population are unknown.<h4>Objective</h4>This study aims to evaluate the effects of remote telemonitoring with team-based management on people with uncontrolled type 2 diabetes.<h4>Design</h4>This was a pr ...[more]

PMID: 31512187

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Project description:BackgroundSelf-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.Methods and findingsWe performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45-12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention.ConclusionsSupported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628.Trial registrationCurrent Controlled Trials ISRCTN 71674628.

Project description:BackgroundSub-optimally controlled diabetes increases risks for adverse and costly complications. Self-management including glucose monitoring, medication adherence, and exercise are key for optimal glycemic control, yet, poor self-management remains common.ObjectiveThe main objective of the Trial to Incentivize Adherence for Diabetes (TRIAD) study was to determine the effectiveness of financial incentives in improving glycemic control among type 2 diabetes patients in Singapore, and to test whether process-based incentives tied to glucose monitoring, medication adherence, and physical activity are more effective than outcome-based incentives tied to achieving normal glucose readings.MethodsTRIAD is a randomized, controlled, multi-center superiority trial. A total of 240 participants who had at least one recent glycated hemoglobin (HbA1c) being 8.0% or more and on oral diabetes medication were recruited from two polyclinics. They were block-randomized (blocking factor: current vs. new glucometer users) into the usual care plus (UC +) arm, process-based incentive arm, and outcome-based incentive arm in a 2:3:3 ratio. The primary outcome was the mean change in HbA1c at month 6 and was linearly regressed on binary variables indicating the intervention arms, baseline HbA1c levels, a binary variable indicating titration change, and other baseline characteristics.ResultsOur findings show that the combined incentive arms trended toward better HbA1c than UC + , but the difference is estimated with great uncertainty (difference - 0.31; 95% confidence interval [CI] - 0.67 to 0.06). Lending credibility to this result, the proportion of participants who reduced their HbA1c is higher in the combined incentive arms relative to UC + (0.18; 95% CI 0.04, 0.31). We found a small improvement in process- relative to outcome-based incentives, but this was again estimated with great uncertainty (difference - 0.05; 95% CI - 0.42 to 0.31). Consistent with this improvement, process-based incentives were more effective at improving weekly medication adherent days (0.64; 95% CI - 0.04 to 1.32), weekly physically active days (1.37; 95% CI 0.60-2.13), and quality of life (0.04; 95% CI 0.0-0.07) than outcome-based incentives.ConclusionThis study suggests that both incentive types may be part of a successful self-management strategy. Process-based incentives can improve adherence to intermediary outcomes, while outcome-based incentives focus on glycemic control and are simpler to administer.

Project description:BACKGROUND:In recent years, the rapid development of mobile medical technology has provided multiple ways for the long-term management of chronic diseases, especially diabetes. As a new type of management model, smartphone apps are global, convenient, cheap, and interactive. Although apps were proved to be more effective at glycemic control, compared with traditional computer- and Web-based telemedicine technologies, how to gain a further and sustained improvement is still being explored. OBJECTIVE:The objective of this study was to investigate the effectiveness of an app-based interactive management model by a professional health care team on glycemic control in Chinese patients with poorly controlled diabetes. METHODS:This study was a 6-month long, single-center, prospective randomized controlled trial. A total of 276 type 1 or type 2 diabetes patients were enrolled and randomized to the control group (group A), app self-management group (group B), and app interactive management group (group C) in a 1:1:1 ratio. The primary outcome was the change in glycated hemoglobin (HbA1c) level. Missing data were handled by multiple imputation. RESULTS:At months 3 and 6, all 3 groups showed significant decreases in HbA1c levels (all P<.05). Patients in the app interactive management group had a significantly lower HbA1clevel than those in the app self-management group at 6 months (P=.04). The average HbA1c reduction in the app interactive management group was larger than that in the app self-management and control groups at both months 3 and 6 (all P<.05). However, no differences in HbA1c reduction were observed between the app self-management and control groups at both months 3 and 6 (both P>.05). Multivariate line regression analyses also showed that the app interactive management group was associated with the larger reduction of HbA1c compared with groups A and B at both months 3 and 6 (all P>.05). In addition, the app interactive management group had better control of triglyceride and high-density lipoprotein cholesterol levels at both months 3 and 6 compared with baseline (both P<.05). CONCLUSIONS:In Chinese patients with poorly controlled diabetes, it was difficult to achieve long-term effective glucose improvement by using app self-management alone, but combining it with interactive management can help achieve rapid and sustained glycemic control. TRIAL REGISTRATION:ClinicalTrials.gov NCT02589730; https://clinicaltrials.gov/ct2/show/NCT02589730.

Project description:ImportanceOnly about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension.ObjectivesTo determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped.Design, setting, and patientsA cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up.InterventionsEight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly.Main outcomes and measuresControl of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped).ResultsAt baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07).Conclusions and relevanceHome BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up.Trial registrationclinicaltrials.gov Identifier: NCT00781365.

Project description:BackgroundAlthough China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China. This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.MethodsA cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N = 5) or a usual care group (N = 5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention includes individualized self-care education prior to discharge and 6-month follow-up in community health service centers. Health professionals from both hospitals and community health service centers will be resourced to collaborate on the implementation of the postdischarge interventions that reinforce self-care. The primary outcome is systolic blood pressure at 6-month follow-up adjusted for baseline value. Secondary outcomes are self-care knowledge, treatment adherence, HbA1c and lipid levels, quality of life, the incidence of adverse events and the incidence of unplanned hospital readmission at 6-month follow-up adjusted for baseline value. A multilevel mixed-effect linear regression model will be used to compare the changes in health outcomes between the intervention and usual care groups.DiscussionThis study will determine whether collaborative care among health professionals between hospitals and community health service centers will improve hypertension management for older people with diabetes in the study sites. The program, if effective, will have an immediate application to hypertension management in the healthcare system in China.Trial registrationAustralia New Zealand Clinical Trials Registry, ACTRN12617001352392 . Retrospectively registered on 26 September 2017.

Project description:BACKGROUND:The prevalence of diabetes is increasing among adults globally, and there is a need for new models of health care delivery. Research has shown that self-management approaches encourage persons with chronic conditions to take a primary role in managing their daily care. OBJECTIVE:The objective of this study was to investigate whether the introduction of a health technology-supported self-management program involving telemonitoring and health counseling had beneficial effects on glycated hemoglobin (HbA1c), other clinical variables (height, weight, body mass index, blood pressure, blood lipid profile), and health-related quality of life (HRQoL), as measured using the Short Form Health Survey (SF-36) version 2 in patients with type 2 diabetes. METHODS:This was a pragmatic randomized controlled trial of patients with type 2 diabetes. Both the control and intervention groups received usual care. The intervention group also participated in additional health promotion activities with the use of the Prescribed Healthcare Web application for self-monitoring of blood glucose and blood pressure. About every second month or when needed, the general practitioner or the diabetes nurse reviewed the results and the health care activity plan. RESULTS:A total of 166 patients with type 2 diabetes were randomly assigned to the intervention (n=87) or control (n=79) groups. From the baseline to follow-up, 36 patients in the intervention group and 5 patients in the control group were lost to follow-up, and 2 patients died. Additionally, HbA1c was not available at baseline in one patient in the intervention group. A total of 122 patients were included in the final analysis after 19 months. There were no significant differences between the groups in the primary outcome HbA1c level (P=.33), and in the secondary outcome HRQoL as measured using SF-36. A total of 80% (67/87) of the patients in the intervention group at the baseline, and 98% (47/50) of the responders after 19-month intervention were familiar with using a personal computer (P=.001). After 19 months, nonresponders (ie, data from baseline) reported significantly poorer mental health in social functioning and role emotional subscales on the SF-36 (P=.03, and P=.01, respectively). CONCLUSIONS:The primary outcome HbA1c level and the secondary outcome HRQoL did not differ between groups after the 19-month follow-up. Those lost to follow-up reported significantly poorer mental health than did the responders in the intervention group. TRIAL REGISTRATION:Clinicaltrials.gov NCT01478672; https://clinicaltrials.gov/ct2/show/NCT01478672 (Archived by WebCite at http://www.webcitation.org/6r4eILeyu).

Dataset Information

Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial.

Background

Objective

Design

Participants

Intervention

Main measure

Results

Conclusion

Trial registration

Publications

Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial.

Similar Datasets

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