Change in Glycemic Control With Use of a Digital Therapeutic in Adults With Type 2 Diabetes: Cohort Study.

BACKGROUND: Intensive lifestyle change can treat and even reverse type 2 diabetes. Digital therapeutics have the potential to deliver lifestyle as medicine for diabetes at scale.

OBJECTIVE: This 12-week study investigates the effects of a novel digital therapeutic, FareWell, on hemoglobin A1c (HbA1c ) and diabetes medication use.

METHODS: Adults with type 2 diabetes and a mobile phone were recruited throughout the United States using Facebook advertisements. The intervention aim was to effect a sustainable shift to a plant-based dietary pattern and regular exercise by advancing culinary literacy and lifestyle skill acquisition. The intervention was delivered by an app paired with specialized human support, also delivered digitally. Health coaching was provided every 2 weeks by telephone, and a clinical team was available for participants requiring additional support. Participants self-reported current medications and HbA1c at the beginning and end of the 12-week program. Self-efficacy related to managing diabetes and maintaining dietary changes was assessed via survey. Engagement was recorded automatically through the app.

RESULTS: We enrolled 118 participants with a baseline HbA1c >6.5%. Participants were 81.4% female (96/118) and resided in 38 US states with a mean age of 50.7 (SD 9.4) years, baseline body mass index of 38.1 (SD 8.8) kg/m2 , and baseline HbA1c of 8.1% (SD 1.6). At 12 weeks, 86.2% (94/109) of participants were still using the app. Mean change in HbA1c was -0.8% (97/101, SD 1.3, P<.001) for those reporting end-study data. For participants with a baseline HbA1c >7.0% who did not change medications midstudy, HbA1c change was -1.1% (67/69, SD 1.4, P<.001). The proportion of participants with an end-study HbA1c <6.5% was 28% (22/97). After completion of the intervention, 17% (16/97) of participants reported a decrease in diabetic medication while 8% (8/97) reported an increase. A total of 57% (55/97) of participants achieved a composite outcome of reducing HbA1c , reducing diabetic medication use, or both; 92% (90/98) reported greater confidence in their ability to manage their diabetes compared to before the program, and 91% (89/98) reported greater confidence in their ability to maintain a healthy dietary pattern. Participants engaged with the app an average of 4.3 times per day. We observed a significantly greater decrease in HbA1c among participants in the highest tertile of app engagement compared to those in the lowest tertile of app engagement (P=.03).

CONCLUSIONS: Clinically meaningful reductions in HbA1c were observed with use of the FareWell digital therapeutic. Greater glycemic control was observed with increasing app engagement. Engagement and retention were both high in this widely distributed sample.