1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Data are available indefinitely at (Link to be included NIL).
   


6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-06-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Summary of Background 

Problem Statement :

According to the International Diabetes Federation, the prevalence estimates of type 2 diabetes mellitus by 2040 will reach to 700 million from the current level of 463 million in 2019. Around three- fourths of this burden live in low and middle income countries including India.^1-3 In India, the number of people with diabetes was 65 million with prevalence of 11.8% as per Ministry of Health and Family Welfare National Diabetes Survey report in 2019.⁴

With this high burden of disease in the country, it is very crucial in controlling the disease burden by continuous monitoring of disease and avoiding complication.⁵ However, the prevention and management of diabetes is largely influenced by individual behavior which can be achieved by extending the support beyond the clinic. This supportive role of patients by empowering individuals with information about the lifestyle and behaviors could be achieved by technology.⁶

Literature review

Following table provides an overview of studies conducted across the world which utilized technology as intervention.

Table 1 Literature review

Bold font represents uniqueness and highlights of the study

Rationale of the study :

During March 2020, to provide equitable access to healthcare in India, NITI Aayog, Government of India, has published the telemedicine guidelines for the practice in India. In India, telemedicine practice for control and management of chronic diseases such as diabetes could help in coverage of services to larger geographical area, given the higher prevalence of diabetes in our country.^7,8

The prevalence of diabetes in India is very high at around 12%. The country has three fourth of its population living in rural areas. Equitable access to healthcare in addition to adequate monitoring is the need of the hour to control the diabetes burden of the country. This gap can be filled by telemedicine practice. Implementing telemedicine in control and monitoring could keep diabetes morbidity in control and avoid progression to complications of diabetes.

The present study is an attempt to assess the impact of health education through technology on control of diabetes.

Novelty / Innovation :

1.Government of India in March 2020, has approved the practice of telemedicine in India and published guidelines to be followed. An RMP may proceed with his/her professional judgment to provide health promotion such as health education and counseling, as well as management of diseases. With this guidelines in place, the present study would assess the impact of such telemedicine practice for diabetes control in India.

2.Previous studies done across the globe using technology utilized short messaging services or software application based intervention, had limitations such as literacy status and lower ability to use the functions of the software application. The present study is planned in such a way that lack of certain factors such as reading and other skills should not interfere with the delivery of health education to patients with diabetes.

3. The present study involves dual service delivery- Interactive voice response system and video tele consultation for patients in intervention arm.

Hypothesis/ Research question 

1.     What is the impact of practice of telemedicine intervention on Diabetes control ?

2.     How effective is the telemedicine practice in controlling the diabetes and maintaining adherence to diabetes management practices ?

Study Objectives

The objectives of the study are

1. To evaluate the effect of intervention on Diabetes control with anthropometric

measures and biochemical parameters.

2. To assess the adherence to diabetes management practices such as adoption of adequate

physical activity, healthy dietary habits, drug compliance and quitting addiction habits.