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A Micro-Randomized Trial Integrating Ecological Momentary Assessment and Continuous Glucose Monitoring in Adults at Risk for Type 2 Diabetes: Feasibility, Engagement, and Data Completeness
ABSTRACT
Background:
Adults at elevated risk for type 2 diabetes may benefit from dietary behavior interventions delivered at moments of heightened need, but the feasibility of combining intensive ecological momentary assessment (EMA), blinded continuous glucose monitoring (CGM), and repeated randomization in this population is not well established.
Objective:
To evaluate the feasibility and acceptability of a 28-day micro-randomized trial integrating intensive EMA, blinded CGM, and randomized delivery of brief dietary intervention prompts in adults at elevated risk for type 2 diabetes.
Methods:
Adults aged 18–65 years with BMI ≥25 kg/m² and elevated diabetes risk wore a blinded CGM for 28 days and were scheduled to receive seven decision points daily. At each decision point, participants were randomized to no prompt, EMA only, or EMA followed by a brief dietary intervention prompt. Feasibility outcomes included retention, randomized decision-point coverage, EMA response, CGM wear, and data completeness. Acceptability was assessed using a post-study survey.
Results:
Of 39 adults enrolled, 35 contributed analyzable EMA and CGM data. Of 6,860 possible decision points, 6,195 (90.3%) were randomized. The EMA response rate was 59.7% (2,466 responses; median per-participant 62%). The remaining prompts (40.3%) reflected both momentary unavailability (e.g., driving or in meetings) and non-engagement. Response rates were higher for EMA-only than for EMA plus intervention prompt (67% vs. 53%). Engagement declined modestly but not significantly (p = .08). Median CGM wear was 27 days, and 91% of participants achieved at least 80% data completeness. Study retention was 91%, and overall acceptability was high (91% satisfied). Subjective ratings of EMA frequency and CGM comfort were not associated with EMA response or CGM wear.
Conclusions:
A 28-day MRT integrating intensive EMA, CGM, and randomized mindfulness-based dietary intervention delivery was feasible and acceptable in adults at high risk for type 2 diabetes. These findings have direct implications for the design of future MRTs addressing dietary behavior related to reducing type 2 diabetes risk.
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