Efficiency of an mHealth App and Chest-Wearable Remote Exercise Monitoring Intervention in Patients with Type 2 Diabetes: Prospective Multicenter Randomized Controlled Trial (Preprint)

Background: Exercise has been recommended as a cornerstone for diabetes management. Supervised exercise is more efficient than unsupervised exercise but is less convenient and accessible. Objective: We aimed to determine the efficiency of exercise using a fitness app and heart rate band to remotely monitor patients with type 2 diabetes in comparison with that of traditional exercise. Methods: Patients with type 2 diabetes without severe complications or comorbidities were recruited to participate in this multicenter randomized controlled trial and were allocated to either the intervention or control group (1:1 ratio). Participants in both groups were asked to engage in moderate to vigorous physical activity for at least 150 minutes per week; each participant was prescribed individualized exercises. Participants in the intervention group were asked to follow exercise videos on the app and to wear a chest band; heart rate, exercise duration, and exercise intensity were recorded by the app. Participants in the control group self-reported exercise intensity and duration. Cardiopulmonary endurance, body composition, blood glucose level, and insulin level were assessed before and after a 3-month exercise program. Results: Of the 101 participants who were enrolled, the majority of them (85/101, 84.2%) completed the study. Both groups had similar baseline characteristics, with the exception that participants in the intervention group were slightly younger and less likely to have hypertension. Self-reported exercise duration was longer than app-recorded exercise duration (control: mean 214 minutes/week; intervention: mean 193 minutes/week); in addition, a higher proportion of participants in the control group (29/41, 71%) than in the intervention group (18/44, 41%) met the 150-minute target for moderate to vigorous physical activity. However, compared with the control group, the intervention group had a larger increase in cardiopulmonary endurance (mean difference –2.0 bpm [beats per minute] vs 1.0 bpm; P=.02) and a larger decrease in body fat percentage (mean difference –1.8% vs –0.8%; P=.01). There was no difference in hemoglobin A1c level reduction between the two groups, yet more participants in the intervention group stopped taking their antidiabetic drugs or had their dosages lowered by an endocrinologist, compared with those in the control group. There were no serious adverse events in either group. Conclusions: This was the first randomized controlled trial in China, to our knowledge, to test the efficiency of exercise using a fitness app and heart rate band to remotely monitor prescribed exercise in patients with type 2 diabetes. The findings of our study suggest that exercise programs may be more efficient if participants are remotely monitored with an app and heart rate band than if participants are not monitored. Trial Registration: Chinese Clinical Trial Register ChiCTR1800015963; http://www.chictr.org.cn/showprojen.aspx?proj=27080