Result: Unlocking Potential: Personalized Lifestyle Therapy for Type 2 Diabetes Through a Predictive Algorithm-Driven Digital Therapeutic.
Original Publication: Foster City, CA : Diabetes Technology Society
0 (Blood Glucose)
0 (hemoglobin A1c protein, human)
Further Information
Background: We present a digital therapeutic (DTx) using continuous glucose monitoring (CGM) and an advanced artificial intelligence (AI) algorithm to digitally personalize lifestyle interventions for people with type 2 diabetes (T2D).
Method: A study of 118 participants with non-insulin-treated T2D (HbA <subscript>1c</subscript> ≥ 6.5%) who were already receiving standard care and had a mean baseline (BL) HbA <subscript>1c</subscript> of 7.46% (0.93) used the DTx for three months to evaluate clinical endpoints, such as HbA <subscript>1c</subscript> , body weight, quality of life and app usage, for a pre-post comparison. The study also included an assessment of initial long-term data from a second use of the DTx.
Results: After three months of using the DTx, there was an improvement of 0.67% HbA <subscript>1c</subscript> in the complete cohort and -1.08% HbA <subscript>1c</subscript> in patients with poorly controlled diabetes (BL-HbA <subscript>1c</subscript> ≥ 7.0%) compared with standard of care ( P < .001). The number of patients within the therapeutic target range (< 7.0%) increased from 38% to 60%, and 33% were on the way to remission (< 6.5%). Patients who used the DTx a second time experienced a reduction of -0.76% in their HbA <subscript>1c</subscript> levels and a mean weight loss of -6.84 kg after six months ( P < .001) compared with BL.
Conclusions: These results indicate that the DTx has clinically relevant effects on glycemic control and weight reduction for patients with both well and poorly controlled diabetes, whether through single or repeated usage. It is a noteworthy improvement in T2D management, offering a non-pharmacological, fully digital solution that integrates biofeedback through CGM and an advanced AI algorithm.
Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J.V., N.T., K.L.P., O.W., and T.S. are employed at Perfood GmbH. T.S. and C.S. are co-founders of Perfood GmbH and minority shareholders. G.F. is general manager and medical director of the Institute for Diabetes Technology (Institut für Diabetes-Technologie (IfDT) Forschungs-und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out clinical studies, eg, with medical devices for diabetes therapy on its own initiative and on behalf of various companies. G.F. and IfDT have received speakers’ honoraria or consulting fees in the last three years from the following companies: Abbott, Berlin Chemie, Boydsense, Dexcom, Lilly Deutschland, Novo Nordisk, Perfood, Pharmasens, Roche, Sinocare, Terumo, and Ypsomed. M.S. runs an Institute for Diabetology and has received speakers’ honoraria or consulting fees in the last three years from Novo Nordisk, Lilly Deutschland, Astra Zeneca, Sanofi, Boehringer Ingelheim, Berlin Chemie, Novartis, and Perfood.