| CTRI Number |
CTRI/2024/11/076829 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Insulin Pump In Type 2 Diabetes |
|
Scientific Title of Study
|
Real world Evidence Generation of data on use of Advanced Hybrid Closed Loop (AHCL) Technology in T2DM in India |
| Trial Acronym |
REGAIN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
Chairman |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology, Room No.:1,
No.4, Conran Smith Road,
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Chairman |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology, Room No.:1,
No.4, Conran Smith Road,
Gopalapuram
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Poongothai |
| Designation |
Senior Scientist and HOD Clinical Trials |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Clinical Trials, First Floor,
No.4, Conran Smith Road,
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
poongothaisubramani@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIA MEDTRONICS
Solitaire Corporate Park, Building No.12, 6th floor Andheri- Ghatkopar Link Road, Andheri (East), Mumbai, 400093 |
|
|
Primary Sponsor
|
| Name |
INDIA MEDTRONICS |
| Address |
Solitaire Corporate Park, Building No.12, 6th floor Andheri- Ghatkopar Link Road, Andheri (East), Mumbai, 400093 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Poongothai |
Dr. V. Mohan, Madras Diabetes Research Foundation |
No.4, Conran Smith Road,
Gopalapuram
Chennai
TAMIL NADU |
9840134505
poongothaisubramani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Advanced Hybrid Closed Loop |
Advanced Hybrid Closed Loop
6 months |
| Comparator Agent |
Multiple daily doses of Insulin |
Multiple daily doses of Insulin
6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants with T2DM
Participants who are using AHCL system
Multiple daily dose insulin
HbA1c values between ≥8.0% and ≤14%.
|
|
| ExclusionCriteria |
| Details |
A history of two or more hypoglycaemia-related seizures or comas within the last 6 months.
Patients who are pregnant or planning to become pregnant are also excluded.
Use of steroids or weight loss medication, abuse of alcohol or drugs.
Patients currently under a psychiatrist’s care or using antipsychotic or mood stabilizer medication or diagnosed to have dementia or bipolar disorder or schizophrenia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The data collected at or near the 3 months post-automation. Time in Range 70-180 mg/dl) of the patient at the prespecified date.
HbA1c change between 2 arms after 6 months. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HbA1c after 3 months and change from baseline to final visit
Total daily dose |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Advanced Hybrid Closed Loop (AHCL) system MiniMed 780G automatically
adjusts basal insulin delivery in
addition to automated bolus corrections, based on continuous glucose monitoring
(CGM) readings, to offer protection
against both hyperglycemia and hypoglycemia. AHCL has shown promising outcomes in improving glycemic outcomes in type 1 diabetesMiniMed 780G is currently intended for the management of
Type 1 diabetes mellitus (T1DM) in persons
requiring insulin, ages seven years and older. However, in India there
are more than 50 people with type 2
diabetes, who are currently using AHCL system to manage type 2 diabetes.
|