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.

Background: Insurers in South Asia are challenged by lack of a culturally relevant and clinically effective lifestyle intervention that can be delivered at scale. This study reports results from participants of a real-world pilot using Wellthy Diabetes™ (WD), a digital therapeutic for people living with type 2 diabetes, in collaboration with an insurance provider with the aim to validate WD as a diabetes management and risk reduction tool. WD was developed in scientific collaboration with the Research Society for Study of Diabetes in India (RSSDI). Methods: A 16-week lifestyle modification program was delivered to persons with T2DM through an Artificial Intelligence (AI) powered smartphone app. The program included behavioral modification training based on structured DSME content, developed along AADE7™ guidelines. The WD app enables users to self-report data on blood glucose, weight, meals, and physical activity and encourages logging through personalized reminders and nudges using an AI-powered digital persuasion model. Participants received real-time feedback and coaching through an AI-powered chatbot and personalized coaching from an expert diabetes coach. A1c measures were conducted at the start and end of the program. This study presents results from 102 program completers who completed follow-up A1c. Results: The mean pre and post-intervention A1c for 102 program completers (mean age: 50.8 years and 68% males) were 8.51% (95% CI:8.23-8.79) and 8.02% (95% CI: 7.72-8.32), respectively, showing a mean post-intervention reduction of -0.49% A1c (95% CI:-0.73 - -0.25, p=0.01). Sixty percent (n=61) of participants reduced their A1c by the end of the program with a mean reduction of -1.17% A1c (95% CI: 0.75-1.60). Conclusion: This study demonstrates Wellthy Diabetes as a clinically effective intervention for Health and Life Insurers in South Asia to improve health outcomes and reduce risk for people with type 2 diabetes through improved glycemic control. Disclosure A.R. Sosale: None. M. Shaikh: Employee; Self; Wellthy Therapeutics Pvt Ltd. A. Shah: Stock/Shareholder; Self; Wellthy Therapeutics.R. Chawla: None.B.M. Makkar: None. J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca.S. Joshi: None.N. Deshpande: None.S. Agarwal: None.A. Maheshwari: None.S. Madhu: None.B.D. Saboo: None.

Objectives Vital to implementation of the World Health Organization (WHO) Safe Childbirth Checklist (SCC), designed to improve delivery of 28 essential birth practices (EBPs), is the availability of safe birth supplies: 22 EBPs on the SCC require one or more supplies. Mapping availability of these supplies can determine the scope of shortages and need for supply chain strengthening. Methods A cross-sectional survey on the availability of functional and/or unexpired supplies was assessed in 284 public-sector facilities in 38 districts in Uttar Pradesh, India. The twenty-three supplies were categorized into three non-mutually exclusive groups: maternal (8), newborn (9), and infection control (6). Proportions and mean number of supplies available were calculated; means were compared across facility types using t-tests and across districts using a one-way ANOVA. Log-linear regression was used to evaluate facility characteristics associated with supply availability. Results Across 284 sites, an average of 16.9 (73.5%) of 23 basic childbirth supplies were available: 63.4% of maternal supplies, 79.1% of newborn supplies, and 78.7% of infection control supplies. No facility had all 23 supplies available and only 8.5% had all four medicines assessed. Significant variability was observed by facility type and district. In the linear model, facility type and distance from district hospital were significant predictors of higher supply availability. Conclusions for Practice In Uttar Pradesh, more remote sites, and primary and community health centers, were at higher risk of supply shortages. Supply chain management must be improved for facility-based delivery and quality of care initiatives to reduce maternal and neonatal harm.

Objective: People with type 2 diabetes mellitus are prescribed to complete a minimum of 30 mins of activity every day. We evaluate the effectiveness of the Wellthy Diabetes (WD) digital therapeutic app in changing health behavior to achieve these activity goals through routine activity, by coaching and nudging them with the help of an artificial intelligence (AI) powered chatbot. Methods: De-identified data from 527 users [Mean = 38 years (95% CI: 36.8- 39.3); 69.7% male] who had used the app for at least 21 days and had activity tracking data for at least 15 days was used. The AI-powered chatbot delivered guidance and education on the importance of exercise for persons with diabetes and encouraged users to engage in routine physical activity through personalized nudges and reminders delivered through an AI-Powered digital persuasion model. The WD app tracked the users’ physical activity via inbuilt sensors on the phone. Results: A total of 46,320 person-days and 8,833 person-weeks of activity tracking was recorded, wherein users were tracked for an average of 87 days (95% CI: 81- 95). We recorded the daily active time (DAT) and weekly active time (WAT). Mean DAT was 35 min (95% CI: 33- 37) with a median of 29.75 min (25th-75th: 18-45 min); it was significantly higher for males (37.5 vs. 29.5 min; p=0.001). Mean WAT was 187 min (95% CI: 174-200) with a median of 153 min (25th-75th: 77-242 min). MDAT was noted to be higher on weekdays (38 min) vs. weekends (35 min, p=0.001). Daily activity targets were achieved on 46.5% person-days (n=21542) and weekly activity targets on 47.5% of person-weeks (n=4197). Conclusion: The results confirm that an AI-powered Digital Therapeutic like the Wellthy Diabetes can be an effective prescriptive tool for physicians to help their patients achieve activity targets. Disclosure B.M. Makkar: None. M. Shaikh: Employee; Self; Wellthy Therapeutics Pvt Ltd. A. Shah: Stock/Shareholder; Self; Wellthy Therapeutics. S. Joshi: None. B.D. Saboo: None. A.R. Sosale: None. S. Madhu: None. R. Kovil: Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Janssen Pharmaceuticals, Inc., MSD Pharmaceuticals Pvt. Ltd.. T. Shah: None. M.S. Chawla: Speaker's Bureau; Self; IPCA Laboratories, Eli Lilly and Company, Novo Nordisk A/S, MSD Pharmaceutical Pvt. Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. Speaker's Bureau; Spouse/Partner; Sanofi. R. Chhawla: None. J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca.

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