| CTRI Number |
CTRI/2021/04/032817 [Registered on: 15/04/2021] Trial Registered Prospectively |
| Last Modified On: |
10/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Diabetes Registry |
|
Scientific Title of Study
|
Hospital based Multi-Centric Diabetes Registry |
| Trial Acronym |
HMDR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Pramila Kalra |
| Designation |
Professor and Head |
| Affiliation |
M S Ramaiah Medical College and Hospitals |
| Address |
Department of Endocrinology
M S Ramaiah Medical College and Hospital
MSRIT Post
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9243257161 |
| Fax |
|
| Email |
kalrapramila@gmail.com |
|
Details of Contact Person Scientific Query
Modification(s)
|
| Name |
Dr Pramila Kalra |
| Designation |
Professor and Head |
| Affiliation |
M S Ramaiah Medical College and Hospitals |
| Address |
Department of Endocrinology
M S Ramaiah Medical College and Hospitals
MSRIT Post
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9243257161 |
| Fax |
|
| Email |
kalrapramila@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Reetu Singh |
| Designation |
Project Manager |
| Affiliation |
M S Ramaiah Clinical Research Centre |
| Address |
M S Ramaiah Clinical Research Centre
1st Floor
M S Ramaiah Advanced Learning Centre
M S Ramaiah Nagar
MSRIT Post
Manager Quality Control
M S Ramaiah Advanced Learning Centre
M S Ramaiah Nagar
MSRIT Post Bangalore KARNATAKA 560054 India |
| Phone |
9886880711 |
| Fax |
|
| Email |
reetu@msrcrc.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical College and Hospitals |
|
|
Primary Sponsor
|
| Name |
BIRAC |
| Address |
Biotechnology Industry Research Assistance Council
Government of India Enterprise
1st Floor
MTNL Building
9 CGO Complex
Lodhi Road
New Delhi 110003 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujoy Ghosh |
Institute Of Post Graduate Education And Research SSKM Hospital |
Department of Endocrinology
Ronald Ross Building
4th floor room
no 9B 244 AJC
Bose Road
Kolkata700020 Kolkata WEST BENGAL |
9674625823
drsujoyghosh2000@gmail.com |
| Dr Pramila Kalra |
M S Ramaiah Medical College and Hospitals |
Department of Endocrinology
M S Ramaiah Nagar
MSRIT Post Bangalore
560054 Bangalore KARNATAKA |
9243257161
kalrapramila@gmail.com |
| Dr Sreejith N Kumar |
Noorul Islam Institute of Medical Science and Research Foundation |
Department of Diabetology
Aralummoodu
Trivandrum
695123 Thiruvananthapuram KERALA |
9847204360
drsnkumar@gmail.com |
| Dr Prasanta Kumar Bhattacharya |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
Department of General Medicine
Mawdiangiand
Shillong
793018 East Khasi Hills MEGHALAYA |
9435030138
pkbdr78@gmail.com |
| Dr Ravi Kiran |
SIMS SRM Institutes for Medical Science |
Department of Endocrinology
No 1 Jawaharlal Nehru Salai
Vadapalani
Chennai
600026 Chennai TAMIL NADU |
9790869797
vmravikiran@yahoo.co.in |
| Dr Gurinder Mohan |
Sri Guru Ram Das University Of Health Sciences, Amritsar, Punjab. |
Department of General Medicine
Mehta Road
Vallah village
Amritsar
143501 Amritsar PUNJAB |
9815341556
drgurinder1968@gmail.com |
| Dr K R Raveendra |
Victoria Hospital Bangalore Medical College and Research |
Department of General Medicine
BMCRI Fort
560002
KR Road
Bangalore Bangalore KARNATAKA |
9448134587
drkrraveendra@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee M S Ramaiah Medical College and Hospitals |
Approved |
| Ethics Committee M S Ramaiah Medical College and Hospitals |
Approved |
| Ethics Committee of BMCRI |
Approved |
| IEC NIMS |
Approved |
| Institutional Ethics Committee North Eastern Indira Gandhi Regional Institute Of Health And Medical Sciences |
Approved |
| Institutional Ethics committee Sri Guru Ram Das inst. of Med. Sci and Research |
Approved |
| Institutional Ethics Committee, SRM Institutes for Medical Science |
Approved |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male female and transgender patients aged greater than or equal to 1 year. Patient visiting the out patient department of the hospital who is a known case of Type 1 or Type 2 Diabetes Mellitus as per their medical records. Patient or parent willing to provide written Assent and or Informed Consent. |
|
| ExclusionCriteria |
| Details |
Patients with Gestational Diabetes Mellitus.
Patients with Drug induced Diabetes Mellitus.
Patients with Secondary Diabetes Mellitus.
Patients not having Indian citizenship.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The findings from diabetes registry will provide important insights into the various aspects of Diabetes Mellitus and its management in Indian Population |
After 3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Data base generated by this registry will be able to clarify various aspects of Type 1 & Type 2 Diabetes Mellitus.
Providing a real-world view of clinical practices of Diabetes Mellitus.
The data will be used to make healthcare policy for Type 1 and Type 2 Diabetes Mellitus patients.
The results can be used to advocate for greater allocation of resources to Diabetes Mellitus care.
Data base generated by this Registry data can be used for future Clinical Trials.
|
After 3 years |
|
|
Target Sample Size
|
Total Sample Size="3000" Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is a hospital based, prospective, longitudinal , observational study which will be conducted without any intervention. Data for this registry will be collected at 7 sites identified by BIRAC across India. The data of patients visiting the Out Patient Departments (OPD) of the hospital of all the collaborating sites who are known case of Diabetes Mellitus will be assessed for eligibility, consecutively invited to enroll for the study after obtaining their informed consent or assent form (if applicable)/ Re consent form already enrolled participants. Thereafter are being followed up after a minimum period of 3 months from the date of enrollment. No additional mandatory follow-up visits, nor interventions will happen. The aim of the study is to develop a Diabetes Mellitus Registry to facilitate recruitment for clinical trials pertaining to Diabetes Mellitus by matching potential subjects interested in participating in clinical research. The primary objective of this registry is to collect data on the demographics, anthropometry, and management of patients with Diabetes Mellitus that can be used to improve the knowledge of epidemiology clinical presentation, management, and complications of Diabetes Mellitus in India. |