| CTRI Number |
CTRI/2024/05/068043 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of personalised coaching program with standard of care in Type 2 diabetes management |
|
Scientific Title of Study
|
A prospective open-label, multi-centre study to evaluate the effectiveness of personalized coaching program when compared to the standard of care in the management of type 2 diabetes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mudit Sabarwal |
| Designation |
Director & Consultant: Diabetology (Endocrinology) |
| Affiliation |
Dharma Diabetes & Metabolic Clinic |
| Address |
Dharma Diabetes & Metabolic Clinic
B-6 Greater Kailash Enclave-2,
Greater Kailash
New Delhi
DELHI
110048
India |
| Phone |
9811255505 |
| Fax |
|
| Email |
drmuditsabharwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punit Srivastava |
| Designation |
Chief Scientific Officer |
| Affiliation |
Mediception Science Pvt Ltd |
| Address |
Mediception Science Pvt Ltd
Unit # 711 & 817, Vipul Business Park
Sector-48, Gurgaon
Haryana.
Gurgaon
HARYANA
122018
India |
| Phone |
8586928449 |
| Fax |
|
| Email |
punit@mediception.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punit Srivastava |
| Designation |
Chief Scientific Officer |
| Affiliation |
Mediception Science Pvt Ltd |
| Address |
Mediception Science Pvt Ltd
Unit # 711 & 817, Vipul Business Park
Sector-48, Gurgaon
Haryana.
Gurgaon
HARYANA
122018
India |
| Phone |
8586928449 |
| Fax |
|
| Email |
punit@mediception.com |
|
|
Source of Monetary or Material Support
|
| Ragus Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Ragus Healthcare Private Limited |
| Address |
Plot- No. 17 & 17C BDA, Sector 3, HSR Layout, Bangalore - 560102 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aravinda Jagadeesha |
Aravinda Diabetic Centre |
Department of Endocrinology, No 14 & 15 3rd Block 4th Stage Basaveshwara Nagar 560079
Bangalore
KARNATAKA |
9916922303
arvi03@yahoo.com |
| Dr Mudit Sabharwal |
Dharma Diabetes & Metabolic Clinic |
Department of Endocrinology, B-6 Greater Kailash Enclave-2
Greater Kailash New Delhi 110048
New Delhi
DELHI |
9811255505
drmudit.sabharwal@gmail.com |
| Dr Banshi Saboo |
Dia Care |
Department of Endocrinology, 1 & 2 Gandhi Park 120 Feet Ring Road
Landmark Near Nehrunagar Circle
Ambawadi 380006
Ahmadabad
GUJARAT |
9824047676
banshisaboo@hotmail.com |
| Dr Manoj Chawla |
Lina Diabetes Care Centre |
Department of Endocrinology, No.704, Cosmos Plaza, Opp Indian Oil Nagar, J P Road Near D N Nagar Metro station Andheri West 400053
Mumbai
MAHARASHTRA |
9820002333
linadiabetes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| Good Society for Ethical Research |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Vision Independent Ethics Committe |
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 |
| Comparator Agent |
Standard of Care (Antidiabetic therapy advised as per physician discretion) |
Standard of Care (Control group who will be only on Antidiabetic therapy advised as per physician discretion);Duration of therapy: 3 Months. Visit1: Screening Visit 2: Baseline (Day 1) Visit 3: End of Study (EOS) (Day 90) |
| Intervention |
Standard of Care (Antidiabetic therapy advised as per physician discretion) + Sugar Fit Diabetes Reversal Management Program (SDRMP) |
Dose, route of administration, and frequency will be decided as per physician discretion +
SDRMP, along with CGM, is integrated into the regular medication for T2DM patients), includes Dietary and life-style modifications
Duration of therapy: 3 Months.
Visit1: Screening
Visit 2: Baseline (Day 1)
Visit 3: End of Study (EOS) (Day 90) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with age group of above 18 years both men and women
2 Patients with history of diabetes with HbA1c greater than 7 with T2DM condition
3 Patients willing to sign an informed consent document
4 Patients who have not participated in any clinical study in the past 30 days
|
|
| ExclusionCriteria |
| Details |
1.Patients diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis
2.Pregnant and lactating subjects
3.Patients with severe co-morbidities or disease conditions (Cardiac or Renal or Cancer)
4.End-stage renal disease or severe renal impairment (creatinine clearance more 30 ml per min)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
â—Improvement in HbA1c levels
â—Improvement in FBS
â—Improvement in weight, waist, and hip circumference
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
â—Reduction in insulin resistance (HOMA IR C-peptide)
â—Reduction in visceral fat adiposity (BCA)
â—Improvement in Fatty liver index (LFT and USG abdomen if available)
â—Measurement of sarcopenia using BCA and MUAC
â—Inflammation Status (Blood CRP)
â—Effect on Blood pressure
â—Improvement in QRISK3 Score
â—Improvement in DDS Score
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
18/06/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
| Diabetes mellitus poses a significant global healthcare challenge, with persistently high and increasing prevalence in India and worldwide. Maintaining effective glycemic control is crucial for preventing complications and improving the quality of life for individuals with diabetes. The American Diabetes Association suggests that achieving the reversal of Type 2 Diabetes Mellitus (T2DM) involves a structured and systematic approach that centers on the management of nutrition, fitness, and lifestyle. This study seeks to explore variations in diabetes management and outcomes, considering patient engagement in Sugar. Fit Diabetes Reversal and Management Program (SDRMP). SDRMP is a personalized intervention study that uses technology-enabled medical management, dedicated coach-led diabetes, and nutrition experts. The effectiveness of SDRMP will be analyzed by comparing it with a control group that involved individuals with T2DM managed by conventional pharmacotherapy but not participating in the SDRMP. | |