The DElhi DIabetes INTervention Trial (DEDINTT)

Recruiting

Conditions: Type 2 diabetes mellitus with unspecified complications,

Registration Number: CTRI/2023/07/054963

Lead Sponsor: ICMR

Brief Summary: Type-2 diabetes is a widely prevalent public health problem, the prevalence has been worsening and the aging population is especially vulnerable to Covid as well. Further, our two city-wide surveys (DEDICOM-II (1) and DEDICOM (2)) conducted 13 years apart (funded by ICMR) documented deterioration in glycemic control amongst known diabetes patients in Delhi especially in the socio-economically weaker sections. This makes it imperative to develop and test potentially effective and scalable interventions to improve glycemic control amongst known diabetes patients.

Available literature suggests that empowering the individual with self-management skills through education helps in achieving good and sustainable glycemic control (3, 4). Many studies on the subject have attempted doctor practice/diabetes educator based self-management education with varying success in the select populations affording and seeking such care. It is understandable that the effectiveness, scalability, and cost effectiveness of such interventions in the wider Indian population remains limited. In this context, our recently concluded cluster randomized community survey provides us with a unique opportunity of working with a pre-engaged community to co-develop a culturally and locally tailored self-management module-based Kit for Diabetes Intervention (EK-DIN). The kit will include all the educational material and devices required to understand DSME in the local language. We propose to subsequently evaluate the effectiveness of EK-DIN, when delivered using the services of trained community leaders, in improving glycemic control (primary outcome) using the Stepped Wedge Cluster Randomized Trial study design amongst the participants of DEDICOM-II (1). The sustainability, cost effectiveness, care seeking behavior and Quality of life impact of the intervention will also be studied as secondary outcomes.

Reference

1. Nagpal J, Rawat S, Goyal S, Lata AS. The poor quality of diabetes care in a cluster randomized community survey from Delhi (DEDICOMâ€II): A crisis, an opportunity. Diabetic Medicine. 2021 Jan 27:e14530.

2. Nagpal J, Bhartia A. Quality of diabetes care in the middle-and high-income group populace: the Delhi Diabetes Community (DEDICOM) survey. Diabetes care. 2006 Nov 1;29(11):2341

3. Asha A, Pradeepa R, Mohan V. Evidence for benefits from diabetes education program. International journal of diabetes in developing countries. 2004;24:96-102.

4. Nicoll KG, Ramser KL, Campbell JD, Suda KJ, Lee MD, Wood GC, Sumter R, Hamann GL. Sustainability of improved glycemic control after diabetes self-management education. Diabetes Spectrum. 2014 Aug 1;27(3):207-11.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 350

Inclusion Criteria

Participated in DEDICOM-II study.

Exclusion Criteria

Cancer, renal, hepatic or intestinal disease requiring continuing treatment or hospital admission (>1 week in last 1 year).
Inability to communicate (due to mental illness or physical disability).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the HbA1c levels between the groups 3 months after the start of intervention.	36 months

Secondary Outcome Measures

Name	Time	Method
1.Comparison of HbA1c in the groups at â€˜trial end pointâ€™	2.Comparison of Lipid profile, blood pressure, drug compliance & preventive checks between the groups

Trial Locations

Locations (1): Sitaram Bhartia Institute of Science and Research
🇮🇳
South, DELHI, India
Sitaram Bhartia Institute of Science and Research
🇮🇳South, DELHI, India
Dr Jitender Nagpal
Principal investigator
01142111111
jitendernagpal@gmail.com