JMIR Publications

ABSTRACT

Background:

Digital therapeutics integrating continuous glucose monitoring (CGM) with personalised lifestyle coaching can enhance glycaemic control in individuals with type 2 diabetes mellitus (T2DM). However, real-world evidence evaluating such multi-component interventions remains limited.

Objective:

This study was conducted aimed to evaluate the effectiveness of the 90-day Goodflip programme, an app-based lifestyle intervention, on glycaemic, anthropometric, lipid, quality-of-life (QoL), and Health Economics and Outcomes Research (HEOR) outcomes in adults with T2DM.

Methods:

A prospective observational cohort study was conducted among adults aged ≥18 years with mildly uncontrolled T2DM (HbA1c 7.5–9.5%). The intervention combined CGM-guided personalised diet, exercise, and cognitive behavioural therapy (CBT) plans delivered via the MyTatva mobile app, supported by multidisciplinary coaching and follow-up calls on days 15, 30, and 60. Primary outcomes were changes in HbA1c, fasting plasma glucose (FPG), postprandial glucose (PPG), and CGM metrics; secondary outcomes included lipid profile, anthropometric indices, QoL, and behavioural metrics.

Results:

Eighteen participants (mean age 49.45 years; 61.1% male) completed the programme. Mean HbA1c reduced by 0.59% (p=0.050), with PPG decreasing by 25.42 mg/dL (p=0.060) and time-in-range improving by 9.98%. Modest, non-significant reductions occurred in LDL-C (−8.38 mg/dL), body fat (−1.13 kg), and waist circumference (−1.56 cm). QoL improved significantly in sleep quality (p=0.046) and other behavioural domains.

Conclusions:

Integrating CGM with app-based, CBT-guided coaching produced clinically meaningful improvements in glycaemic and behavioural outcomes, supporting its use as an effective adjunct to conventional diabetes care. Clinical Trial: The study protocol was reviewed and approved by the Institutional Ethics Committee of Aatman Hospital (EC/NEW/INST/2021/11802) and registered with the Clinical Trials Registry–India (CTRI/2024/08/071850). All study procedures adhered to the principles outlined in the Declaration of Helsinki and its subsequent amendments, and electronic informed consent was obtained from each participant prior to enrolment.