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. 2021 Mar 25;23(3):e17908.
doi: 10.2196/17908.

Evaluating Glycemic Control in Patients of South Asian Origin With Type 2 Diabetes Using a Digital Therapeutic Platform: Analysis of Real-World Data

Arjun Krishnakumar  1 , Ritika Verma  1 , Rajeev Chawla  2 , Aravind Sosale  3 , Banshi Saboo  4 , Shilpa Joshi  1 , Maaz Shaikh  1 , Abhishek Shah  1 , Siddhesh Kolwankar  1 , Vinod Mattoo  1
Affiliations

Evaluating Glycemic Control in Patients of South Asian Origin With Type 2 Diabetes Using a Digital Therapeutic Platform: Analysis of Real-World Data

Arjun Krishnakumar et al. J Med Internet Res. .

Abstract

Background: Digital therapeutics are evidence-based therapeutic interventions driven by high-quality software programs for the treatment, prevention, or management of a medical disorder or disease. Many studies in the western population have shown the effectiveness of mobile app-based digital therapeutics for improving glycemic control in patients with type 2 diabetes (T2D). However, few studies have assessed similar outcomes in the South Asian population.

Objective: This study aims to investigate the real-world effectiveness of the Wellthy CARE digital therapeutic for improving glycemic control among the South Asian population of Indian origin.

Methods: We analyzed deidentified data from 102 patients with T2D from India enrolled in a 16-week structured self-management program delivered using the Wellthy CARE mobile app. Patients recorded their meals, weight, physical activity, and blood sugar in the app, and they received lessons on self-care behaviors (healthy eating, being active, monitoring, medication adherence, problem solving, healthy coping, and reducing risks); feedback provided by an artificial intelligence-powered chatbot; and periodic interactions with certified diabetes educators via voice calls and chats. The primary outcome of the program was a change in glycated hemoglobin A1c (HbA1c). Secondary outcomes included the difference between preintervention and postintervention fasting blood glucose (FBG) and postprandial blood glucose (PPBG) levels; changes in BMI and weight at the completion of 16 weeks; and the association between program engagement and the changes in HbA1c, FBG, and PPBG levels.

Results: At the end of 16 weeks, the average change in HbA1c was -0.49% (n=102; 95% CI -0.73 to 0.25; P<.001). Of all the patients, 63.7% (65/102) had improved HbA1c levels, with a mean change of -1.16% (n=65; 95% CI -1.40 to -0.92; P<.001). The mean preintervention and postintervention FBG levels were 145 mg/dL (n=51; 95% CI 135-155) and 134 mg/dL (n=51; 95% CI 122-146; P=.02) and PPBG levels were 188 mg/dL (n=51; 95% CI 172-203) and 166 mg/dL (n=51; 95% CI 153-180; P=.03), respectively. The mean changes in BMI and weight were -0.47 kg/m2 (n=59; 95% CI -0.22 to -0.71; P<.001) and -1.32 kg (n=59; 95% CI -0.63 to -2.01; P<.001), respectively. There was a stepwise decrease in HbA1c, FBG, and PPBG levels as the program engagement increased. Patients in the highest tertile of program engagement had a significantly higher reduction in HbA1c (-0.84% vs -0.06%; P=.02), FBG (-21.4 mg/dL vs -0.18 mg/dL; P=.02), and PPBG levels (-22.03 mg/dL vs 2.35 mg/dL; P=.002) than those in the lowest tertile.

Conclusions: The use of the Wellthy CARE digital therapeutic for patients with T2D showed a significant reduction in the levels of HbA1c, FBG, and PPBG after 16 weeks. A higher level of participation showed improved glycemic control, suggesting the potential of the Wellthy CARE platform for better management of the disease.

Keywords: behavior change; diabetes self-management; digital therapeutics; lifestyle intervention; mobile phone; type 2 diabetes.

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Conflict of interest statement

Conflicts of Interest: AS is the chief executive officer and a shareholder of Wellthy Therapeutics Pvt Ltd. MS and AK are former employees and shareholders in Wellthy Therapeutics Pvt Ltd. SK is a current employee of Wellthy Therapeutics Pvt Ltd. RV is a current consultant in Wellthy Therapeutics Pvt Ltd. VM and SJ are former consultants of Wellthy Therapeutics Pvt Ltd.

Figures

Figure 1
Figure 1
Participant recruitment and retention flowchart.
Figure 2
Figure 2
Comparison of HbA1c levels. (A) Mean change in HbA1c among all participants, (B) mean change in HbA1c among those who had improvements in HbA1c levels, (C) relationship between program engagement and change in HbA1c levels, and (D) mean change in HbA1c among responders and nonresponders. Error bars represent confidence intervals. HbA1c: hemoglobin A1c.
Figure 3
Figure 3
Change in blood sugar levels. Difference between (A) mean FBG levels and (B) mean PPBG levels reported in the first week and final week of the intervention. Relationship between mobile app use and change in (C) FBG and (D) PPBG levels. Error bars represent confidence intervals. FBG: fasting blood glucose; PPBG: postprandial blood glucose.
Figure 4
Figure 4
(A) Difference in the mean preintervention PPBG between nonresponders and responders. (B) Difference in the mean change in PPBG between the nonresponders and responders. PPBG: postprandial blood glucose.
Figure 5
Figure 5
Change in BMI and weight. Difference between the (A) mean BMI and (B) mean weight reported in the first week and final week of the intervention.
See this image and copyright information in PMC

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