The Effect of an mHealth remote monitoring exercise intervention on clinical outcomes in type 2 diabetes patients: a randomized controlled study (Preprint)
BACKGROUND Exercise has been recommended as a cornerstone for diabetes management. Supervised exercise is more effective than unsupervised exercise, but is less convenient and inaccessible for most subjects. Exercise under remote monitoring by fitness app and heart rate band may be useful to improve exercise efficiency. OBJECTIVE To determine the feasibility and effectiveness of exercise on type 2 diabetes under remote monitoring using fitness app and heart rate monitor compared with traditional exercise. METHODS This is a prospective, multi-center, randomized controlled trial (RCT). Type 2 diabetic patients without severe complications or comorbidities were recruited. Both groups were asked to follow the same exercise prescription. The app group was given heart rate band plus remote monitoring by app, while the control group was given traditional exercise guidance. Cardiopulmonary endurance, indices of body composition, and other parameters were assessed before and after intervention. The study had an average follow-up of 3 months. RESULTS 101 patients were enrolled and 85 completed the study. With the exception of age and history of hypertension, two groups were similar in most clinical measures. Self-reported total exercise time in control group was longer than app-recorded time in app group (214 vs 193 min/week). However, compared with control group, app group had a larger increase in cardiopulmonary endurance (-2.0 vs 1.0 beats/min, p=0.023) and a larger decrease in body-fat percentage (-1.8 vs-0.8%, p=0.013). There was no difference in HbA1c between two groups, yet four subjects in app group stopped taking hypoglycemic drugs and nine lowered drug dosage, compared with one and two in the control group. There were no serious adverse reactions in both groups. CONCLUSIONS This was the first pragmatic RCT in China that tested the feasibility and preliminary efficacy of the effect of exercise under remote monitoring using app and heart rate band. This study suggested that exercise remotely supervised by app and heart rate band were more effective than unsupervised exercise in patients with type 2 diabetes. CLINICALTRIAL Chinese Clinical Trial Registry number, ChiCTR1800015963