Accepted for/Published in: JMIR Diabetes
Date Submitted: Jul 25, 2022
Date Accepted: Oct 11, 2022
Date Submitted to PubMed: Oct 13, 2022
Clinical Utility of a Digital Therapeutic Intervention in Indian Patients with Type 2 Diabetes Mellitus: A 12-week, prospective, single-arm, intervention study
ABSTRACT
Background:
Type 2 diabetes (T2D) patients with elevated levels of blood glucose and glycated hemoglobin (HbA1c) are at higher risk of metabolic and vascular complications. Multiple pharmacotherapeutic drugs and their combinations are available to treat Diabetes. Nonetheless, the goal of optimal glycemic control cannot be met with pharmacotherapy alone.
Objective:
This study examines the efficacy of digital therapeutic intervention by Phable Care as supplementary therapy to achieve the recommended disease control in Type 2 Diabetes.
Methods:
This was a 12-week, prospective open-label, single-arm digital intervention study in T2D patients receiving regular antidiabetic treatment. The eligibility criteria included male and female patients with HbA1c ≥ 6.5%, functional English literacy, and a mobile phone capable of running the intervention app. Efficacy endpoints of the study were mean change in HbA1c, fasting blood glucose (FBG), postprandial blood glucose (PPBG), BMI, and HOMA-IR index at the end of 12 weeks.
Results:
A total of 136 subjects were recruited for the trial out of which 128 subjects completed the study period of 12 weeks. There were 70 (54.69%) men and 58 (45.31%) women with a mean age of 48.48 ± 10.27 years. At the end of 12 weeks the mean change in HbA1c, FBG, PPBG and BMI for the overall study population was -0.84 % (P <0.0001), -9.0 mg/dl (P=0.0215), -15.0 mg/dl (P=0.0003) and -0.24 kg/m2 (P=0.0584) respectively. Among the participants who had an improvement in the HbA1c value at the end of 12 weeks (n=98, 76.56% of total subjects), the mean change in HbA1c, FBG, PPBG and BMI was -1.24 % (P<0.0001), -12.42 mg/dl (P=0.0032), -21.45 mg/dl (P<0.0001) and -0.34 kg/m2 (P=0.0069) respectively. Although not statistically significant, there was an increase in HOMA-IR values for the study population (0.54, P=0.2877). HbA1c response showed significant association with baseline HbA1c level of ≥ 7.5%, no prior history of smoking, and COVID infection as well as higher levels of program engagement.
Conclusions:
Digital therapeutic intervention when used along with standard medications significantly reduces the HbA1c, FBG, and PPBG levels in T2D patients.
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