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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. 

 
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