| CTRI Number |
CTRI/2022/01/039251 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Analysis |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A retrospective data collection study of type-2 diabetic patients in India |
|
Scientific Title of Study
|
A retrospective data collection of Hb1Ac, fasting blood sugar, weight and medication history of type-2 diabetic patients at baseline and three-months |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Yadav |
| Designation |
Senior Project Manager |
| Affiliation |
Triomics Healthcare Private Limited |
| Address |
Regus Level 5, Tower C,
Green Boulevard, Block B,
Sector 62, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9310816793 |
| Fax |
|
| Email |
sunil@triomics.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Yadav |
| Designation |
Senior Project Manager |
| Affiliation |
Triomics Healthcare Private Limited |
| Address |
Regus Level 5, Tower C,
Green Boulevard, Block B,
Sector 62, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9310816793 |
| Fax |
|
| Email |
sunil@triomics.in |
|
Details of Contact Person
Public Query
|
| Name |
Sunil Yadav |
| Designation |
Senior Project Manager |
| Affiliation |
Triomics Healthcare Private Limited |
| Address |
Regus Level 5, Tower C,
Green Boulevard, Block B,
Sector 62, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9310816793 |
| Fax |
|
| Email |
sunil@triomics.in |
|
|
Source of Monetary or Material Support
|
| Ragus Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Ragus Healthcare Private Limited |
| Address |
No. 17 and 17C BDA, Sector 3, HSR Layout, Bangalore, 560102,
Karnataka, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rohit jain |
DIVINE Multispecialty Hospital and Cancer Centre |
Emergency department, Ground floor,Divine Multispecialty Hospital and cancer center, 102/2, Main Jagatpur Road, Near street No.14, Wazirabad, 110084
North
DELHI |
9212410444
rohitjain4783@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Sehgal Nursing Home |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients with Type 2 diabetes mellitus of 18 to 70 years of age (both inclusive)
2. Patients with HbA1c value between 6.5% and 9.0% (both inclusive)
3. The subject records to be captured must not be more than 12 months old
|
|
| ExclusionCriteria |
| Details |
1. Subject with Type-1 diabetes
2. HbA1c < 6.5%
3. Diabetic complications (Neuropathy, Nephropathy, retinopathy and amputation)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To collect retrospective data on the following parameters at two different time-points at an interval of 90 days (±10 days):
a) Fasting Blood Sugar (FBS)
b) HbA1c
c) Medications
d) Weight |
Baseline and Day 90 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/01/2022 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The prevalence of type 2 diabetes is expanding exponentially in the world especially in developing countries. India is the diabetes capital of the world with an alarming increase of the condition across all age groups. According to the latest International Diabetes Federation’s Diabetes Atlas 2021, in southeast asia alone: 1 in 11 adults (90 million) are living with diabetes. The number of adults with diabetes is expected to reach 113 million by 2030 and 151 million by 2045. 747,000 deaths were caused by diabetes in 2021. The ability of an individual living with diabetes to have human-to-human contact with their healthcare provider is not keeping pace with the number of people developing diabetes This study has been designed to develop a better understanding around the variability of Hb1Ac, fasting blood sugar, weight, and medication in type-2 diabetic patients and understand their correlations. |