Abstract
BACKGROUND: A new app, Sukaribit, was designed to enable contact between the caregiver and the patient with the intent to improve self-care and glycemic control (hemoglobin A(1c) [HbA(1c)]). OBJECTIVE: This study investigated the feasibility of the study methodology and the intervention in preparation for a larger effectiveness study. METHODS: Adults with type 2 diabetes were recruited in this randomized controlled feasibility study with a mixed methods design. The intervention group (n=28) tried Sukaribit for 2 months. They were encouraged to report blood glucose levels and medications, and they received feedback from a physician. The control group (n=31) received standard care. Both groups were evaluated with pre and postmeasurements of glycemic control (HbA(1c)), diabetes distress, physical activity, and self-care. Feasibility was evaluated against 5 progression criteria regarding recruitment, study methods, and active participation. RESULTS: Of the 5 progression criteria, only 2 were met or partially met. The recruitment process exceeded expectations, and data collection worked well for self-reported data but not for HbA(1c) measured with a home testing kit. The participants were less active than anticipated, and the effect sizes were small. Only the number of blood glucose tests per day was positively affected by the intervention, with 0.6 more tests per day in the intervention group. CONCLUSIONS: Recruitment of participants to a future fully powered study may work with minor adjustments. The collection of HbA(1c) using home testing constituted a major problem, and an alternative strategy is warranted. Finally, the app was not used as intended. In order to proceed with a larger study, the app and study procedures need improvement.