| CTRI Number |
CTRI/2024/08/071851 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Digital Therapeutics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Impact of MyTatva Application in Managing Type II Diabetes in Real-World Settings |
|
Scientific Title of Study
|
A Real World evidence study to evaluate the Impact of MyTatva Application in the Management of Type II Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| T2400201 version no. 01 dated 01/05/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saboo Banshi Damodarlal |
| Designation |
Diabetologist & Endocrinologist |
| Affiliation |
Diabetes Care and Hormone Clinic |
| Address |
DiaCare Research, Department of Endocrine, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9824047676 |
| Fax |
|
| Email |
banshisaboo@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saboo Banshi Damodarlal |
| Designation |
Diabetologist & Endocrinologist |
| Affiliation |
Diabetes Care and Hormone Clinic |
| Address |
DiaCare Research, Department of Endocrine, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8208716680 |
| Fax |
|
| Email |
banshisaboo@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krunal Chaudhari |
| Designation |
Medical Monitor |
| Affiliation |
Digicare Health Solutions Private Limited |
| Address |
Digicare Health Solutions Private Limited
Division- Medical Affairs
8th Floor, Astron Tower, Iscon Cross Road, Satellite, AHMEDABAD, Gujarat, India - 380015
Digicare Health Solutions Private Limited
Division- Medical Affairs
8th Floor, Astron Tower, Iscon Cross Road, Satellite, AHMEDABAD, Gujarat, India - 380015
Ahmadabad
GUJARAT
380015
India |
| Phone |
8208716680 |
| Fax |
|
| Email |
krunal.chaudhari@tatvacare.in |
|
|
Source of Monetary or Material Support
|
| Digicare Health Solutions Private Limited
Division- Medical Affairs
8th Floor, Astron Tower, Iscon Cross Road, Satellite, AHMEDABAD, Gujarat, India - 380015 |
|
|
Primary Sponsor
|
| Name |
Digicare Health Solution Private Limited |
| Address |
4th Floor, Plot No. 115/5, TP Scheme No. 51, Road, off Ambli, Sanidhya, Bopal, Ahmedabad, Gujarat 380058 |
| Type of Sponsor |
Other [Digital Health Tech Company] |
|
|
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 Banshi Damodarlal Saboo |
Dia Care Research |
1-2 Gandhi Park Society, Ground Floor, Near Nehrunagar Cross Road, Ambavadi
Ahmadabad
GUJARAT |
9824047676
banshisaboo@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital |
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 |
MyTatva Mobile Application |
The MyTatva App is a digital platform for patients with Type II Diabetes that provides lifestyle intervention for a duration of 3 months, through a personalized approach that includes diet, exercise, and behavioral therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female aged at least 18 years with
confirmed diagnosis of Type II Diabetes
Mellitus.
2. Subject diagnosed with Type II Diabetes
Mellitus with HbA1c 7.5% to 9.5%.
3. Patients with access to a smartphone with
internet access/data plan.
4. Patients who understand and speak English
sufficiently to be able to use the MyTatva
Patient application.
5. Patient is willing to comply with all study
procedures and is available for the duration
of the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• The percentage of patients with improvement in Time in Range (TIR) from the baseline (first 2 weeks) to the end of 12 weeks (last 2 weeks)
• The percentage of patients with reduction in Time above Range (TAR) from the baseline (first 2 weeks) to the end of 12 weeks (last 2 weeks)
• The percentage of patients with improvement in Time below Range (TBR) from the baseline (first 2 weeks) to the end of 12 weeks (last 2 weeks)
• The percentage of patients with improvement in FBG (mg/dL) from baseline to the end of 12 weeks.
• The percentage of patients with improvement in PPBG (mg/dL) from baseline to the end of 12 weeks.
• The percentage of patients with reduction in HbA1c (%) from baseline to the end of 12 weeks.
|
From baseline to the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in the BMI (kg/m2) from baseline to the end of 12 weeks.
• Change in the waist circumference (cm) from baseline to the end of 12 weeks.
• Change in Serum LDL, Serum HDL, Serum VLDL, Serum Triglyceride and Total Cholesterol (mg/dL) from baseline to the end of 12 weeks.
• Change in BCA Parameters like Skeletal Muscle Mass(kg) and Body Fat Mass (kg) from baseline to the end of 12 weeks.
|
From baseline to the end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/08/2024 |
| Date of Study Completion (India) |
09/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Trial Synopsis: MyTatva Application in the Management of Type II Diabetes Mellitus Design: A prospective, open-labeled, single-arm, Real-world Evidence study to evaluate the impact of MyTatva application in Type II Diabetes Mellitus patient management. Duration: 12 weeks per patient. Sample Size: 20 patients Population: Patients diagnosed with Type II Diabetes Mellitus Regimen: Patients will receive MyTatva Diabetes Care Plan access via the patients’ smartphone using MyTatva app. The patients will receive personalized diet plans, exercise plans, and cognitive behaviour therapy (CBT). |