App-Based Digital Therapeutics Integrating Continuous Glucose Monitoring for Glycemic Control in Type 2 Diabetes: Prospective Observational Cohort Study.

Abstract

Background: Digital therapeutics integrating continuous glucose monitoring (CGM) with personalized lifestyle coaching can enhance glycemic control in individuals with type 2 diabetes mellitus (T2DM). However, real-world evidence evaluating such multicomponent interventions-combining CGM with nutrition coaching, physiotherapy, and cognitive behavioral therapy within a unified digital platform-remains limited in South Asian populations.

Objective: This study aimed to evaluate the effectiveness of an app-based lifestyle-integrated intervention program (Glycemic Lifestyle Intervention in Diabetes Empowerment-CGM; GLIDE-C) on glycemic, anthropometric, lipid profile, quality of life (QoL), and behavioral outcomes, as well as outcomes related to HEOR (health economics and outcomes research), in adults with mildly uncontrolled T2DM.

Methods: A prospective observational cohort study was conducted among adults aged ≥18 years with confirmed T2DM and baseline hemoglobin A1c (HbA1c) between 7.5% and 9.5%. The intervention was delivered via the Goodflip mobile app, including a 15-day CGM period and a structured analysis of glucose variations, among other clinical assessments, with follow-up on days 15, 30, and 60. The digital intervention combined CGM-guided personalized diet, exercise, and cognitive behavioral therapy plans delivered through the mobile app, supported by multidisciplinary coaching. Primary outcomes were changes in HbA1c, fasting plasma glucose, postprandial glucose, and CGM metrics; secondary outcomes included lipid profile, anthropometric indices, QoL, and behavioral determinants of glycemic improvement.

Results: Eighteen participants (mean age 49.45, SD 10.91 years; n=11, 61.1% male) completed the program. Mean HbA1c decreased by 0.59% (P=.05), with postprandial glucose decreasing by 25.42 mg/dL (P=.06) and time in range increasing by 9.98%. Modest reductions, consistent with the short intervention duration, occurred in low-density lipoprotein cholesterol (-8.38 mg/dL), body fat (-1.13 kg), and waist circumference (-1.56 cm). QoL improved significantly for sleep quality (P=.04). Improvements were also observed for motivation (P=.06), stress management (P=.08), and mood (P=.12), although these changes were not statistically significant. Behavioral analysis demonstrated strong associations with glycemic outcomes; all participants who reduced their consumption of energy-dense, nutrient-poor foods experienced improvements in HbA1c, whereas those who did not reduce energy-dense, nutrient-poor intake showed less favorable outcomes.

Conclusions: The novel GLIDE-C program demonstrated clinically meaningful improvements in glycemic control, behavioral outcomes, and QoL in adults with T2DM, without pharmacological modification. These findings strengthen the role of integrated, CGM-guided digital therapeutic platforms as an effective adjunct to the conventional standard of care.