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.

Keywords: cluster-randomized; glucose; self-monitoring; telemonitoring; type 2 diabetes.

Figure 1

Study flow diagram.

Figure 2

a Model estimated changes in mean hemoglobin A_1cover time. The intervals represent pointwise 95% confidence interval for each group. b Weekly number of tests that were performed and reported by participants. Lines represent the locally weighted smoothing using a moving average across the observed test reported.