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

Abstract

BackgroundIntensive lifestyle change can treat and even reverse type 2 diabetes. Digital therapeutics have the potential to deliver lifestyle as medicine for diabetes at scale.ObjectiveThis 12-week study investigates the effects of a novel digital therapeutic, FareWell, on hemoglobin A1c (HbA1c) and diabetes medication use.MethodsAdults 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.ResultsWe 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).ConclusionsClinically 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.

Improving the scientific rigour of nutritional recommendations for adults with type 2 diabetes: A comprehensive review of the American Diabetes Association guideline‐recommended eating patterns

“…We identified nine studies not included in the ADA review, three of which were published after the 2018 standards (Table S4). Three RCTs found reductions in HbA1c from baseline, and two found the test diet superior compared to the control diet .…”

“…57 A follow-up study 59 to the 2011 study by Kahleova et al 53 found that the significant improvements (from baseline) in HbA1c had regressed over time, even though the intervention arm maintained a significant weight loss and higher level of antiglycaemic medication reduction at 24 months. A singlearm demonstration study 61 found a plant-based diet, coupled with digital support, was effective for glycaemic control, according to patient-reported HbA1c outcomes, while another non-randomized study found no significant change in glycaemic control compared to both baseline and the control diet. 57 In addition, we found three systematic reviews with meta-analysis.…”

Improving the Scientific Rigor of Nutritional Recommendations for Adults with Diabetes: A Comprehensive Review of the American Diabetes Association Guidelines Recommended Eating Patterns

“…59 A follow-up study 57 to the 2011 Kahleova trial 53 found that the significant improvements (from baseline) in HbA1c had regressed over time, even though the intervention arm maintained a significant weight loss and higher level of antiglycemic medication reduction at 24 months. A single-arm demonstration study 61 found a plant-based diet coupled with digital support was effective for glycemic control, according to patient-reported outcomes on HbA1c, while another non-randomized study found no significant change in glycemic control, compared to both baseline and the control diet. 59 In addition, we found three systematic reviews with metaanalysis.…”

“…59 In addition, we found three systematic reviews with metaanalysis. Yokoyama et al 61 found that the evidence supports plant-based diets for glycemic control, but had left out the follow-up Kahleova study, while Ajala et al 40 concluded that the evidence is only suggestive of benefit. Lastly, a systematic review with network meta-analysis 43 did not find plant-based diets to be superior to other eating patterns for T2D.…”

Improving the Scientific Rigor of Nutritional Recommendations for Adults with Diabetes: A Comprehensive Review of the American Diabetes Association Guidelines Recommended Eating Patterns

“…[31][32][33][35][36][37] Additional evidence. We identified nine studies [36][37][38][39][40][41][42][43][44] not included in the ADA review, two of which were published after the 2018 Standards (Supplemental Table S3). Of the three RCTS found, two reported significant improvements in glycemic control 36,40 in the plant-based arm and one did not.…”