Hospital based Multi-centric Diabetes Registry

Abstract

Non-communicable chronic diseases, particularly Diabetes mellitus, a silent epidemic of this era, are rapidly on the rise in India. It is critical to devise strategies to ensure effective diagnosis, prevention, and treatment of the increasing disease burden. Given the lack of large-scale information on Type 1 and Type 2 Diabetes mellitus, the pan-India diabetes registry is hugely pertinent to the Indian situation. The registry would be able to continuously provide data on real-world practices and standard of care for Diabetes mellitus in India. To ensure the correct blend in site selection, the centers have been chosen from different geographical regions across India with a combination of government and private sectors. All the sites will harmonize in terms of protocol, training, SOPs, and data management. This hospital-based observational cross-sectional registry will be carried out without any intervention. Patients who are known cases of Type 1 and Type 2 Diabetes mellitus visiting the outpatient departments (OPD) of all the seven Hospitals will be evaluated for eligibility and willingness to participate in future clinical trials after acquiring their informed consent or assent form (for minors). A common IT platform for entering and preserving registry data will be developed, which will enable us to establish a central database that could be utilized for future clinical trials. This will minimize the time and expense of setting up a Diabetes mellitus repository.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was funded by NBM-BIRAC/DBT

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Karnataka, M S Ramaiah Medical College and Hospitals, Bangalore 560054

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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