First made-in-India “digital pill” to undergo South Asia’s first-of-its-kind clinical trial for diabetes

New Delhi: The #WeDiDiT (Wellthy Digital Diabetes Therapy) trial is all set to prove the efficacy of its 16-week structured diabetes management programme delivered through a mobile app. The trial was launched by Past President of RSSDI, Dr Sarita Bajaj at the RSSDI Annual Conference in Bhubaneswar in the first week of November. The outcome of this multi-center randomized control trial will be measured by the HbA1C levels of patients before and after the trial.

As part of the programme, personalized diabetes self-management education and real time coaching will be offered through dedicated health coaches and an artificial intelligence powered chat bot, to engage and improve the health of patients with type 2 diabetes by facilitating behavior change.

Commenting on the first-of-its-kind initiative in India, Mr Abhishek Shah, Co-founder and CEO of Wellthy Therapeutics said, “On World Diabetes Day, we re-affirm our commitment to solve for the diabetes epidemic. Conducting a clinical trial on a mobile app is unprecedented in India and we are extremely optimistic about the study outcomes. While the Wellthy app has already demonstrated its efficacy in various pilot studies, this formal clinical trial conducted with the RSSDI will provide the evidence necessary to show that digital therapeutics have the potential to improve the lives of diabetes patients in India and around the world.”

The diabetes burden in India is enormous. As per data by the International Diabetes Federation, there are an estimated 69.1 million people living with diabetes in India and another 77.2 million with pre-diabetes which is a high-risk condition for diabetes and cardio-vascular disease. 

Dr Rajeev Chawla, Current President Elect of RSSDI said, “The need for digital interventions in diabetes care is more now than ever, especially in India. The Wellthy Diabetes intervention is an innovation born out of India, for Indians and South Asians. This clinical trial holds tremendous potential in terms of changing outcomes for persons living with diabetes by making it easier for them to manage their blood sugar levels and improving their overall quality of life.”

Dr Sarita Bajaj, the Past President of RSSDI added, “Wellthy and RSSDI together are set to launch the first ever landmark trial in South Asia to test the impact of using digital technologies to manage diabetes, which is the need of the hour today. The RSSDI doctors conducting the trial will offer the app to their patients to download, and as the intervention progresses, study how it impacts their patients and their clinical management. “

Diabetes is a chronic disease that requires treatment for life. This makes adherence to blood sugar controlling lifestyle modifications such as healthy eating, physical activity, and timely medication mandatory. It is common for patients to make an error in their diabetes management by either overeating carbohydrates on a particular day, not exercising enough, or forgetting to take their medicine.

“From a patient safety perspective, the benefits offered by digital therapeutics are immense. Diabetes care needs to be continual versus the episodic care available today, and patient journey data like this is essential for the treating doctor to further personalize advice and pharmacological care. It is the ultimate win-win designed with a patient-centric approach, enhancing quality of care, access and affordability.” noted Mr Shah.