| CTRI Number |
CTRI/2017/03/008278 [Registered on: 31/03/2017] Trial Registered Prospectively |
| Last Modified On: |
31/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the effectiveness digital diabetes program and coaching in achieving better control of blood sugar |
|
Scientific Title of Study
|
To study the efficacy of a doctor led digital diabetes program aided by a data driven coaching intervention process in achieving better glycemic control in uncontrolled type II diabetics |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Singh |
| Designation |
Head Program Development |
| Affiliation |
Curo Healthcare Technologies Private Limited |
| Address |
Curo Healthcare Technologies Private Linited, 805, Tower B, Millenium Plaza,
Sushant Lok Phase I, Sector 29, Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
7046014774 |
| Fax |
|
| Email |
seema@lifeincontrol.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Singh |
| Designation |
Head Program Development |
| Affiliation |
Curo Healthcare Technologies Private Limited |
| Address |
Curo Healthcare Technologies Private Limited, 805, Tower B, Millenium Plaza,
Sushant Lok Phase I, Sector 29, Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
7046014774 |
| Fax |
|
| Email |
seema@lifeincontrol.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Singh |
| Designation |
Head Program Development |
| Affiliation |
Curo Healthcare Technologies Private Limited |
| Address |
Curo Healthcare Technologies Private Limited, 805, Tower B, Millenium Plaza,
Sushant Lok Phase I, Sector 29, Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
7046014774 |
| Fax |
|
| Email |
seema@lifeincontrol.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Karnataka |
| PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Curo Healthcare Technologies Private Limited |
| Address |
805, Tower b, Millenium Plaza, Sushant lok Phase I, Sector 29, Gurgaon, Haryana |
| Type of Sponsor |
Other [Digital Health Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthik Rao N |
Kasturba Medical College Hospital |
Room 206, Department of Medicine Office Area,
Sharada Madhava Pai OPD Block, KMCH – Manipal
Udupi
KARNATAKA |
9886124423
karthikrao85@gmail.com |
| Dr Sanjay Bhadada |
Nehru Hospital |
Department of Endocrinology, Nehru Hospital, 4th Floor, F - Block, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
0172-2756582
bhadadask@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Submittted/Under Review |
| Kasturba Hospital, Manipal Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes Type 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diet advice |
Diabetic diet |
| Intervention |
Diet advice,Mobile app, Diabetes coaching |
Diabetic diet, "Lifeincontrol" mobile app for self management, data driven diabetes coaching |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with uncontrolled type II diabetes (HbA1c > 8.5%) with age: 18-55 years
2.Patient should have an android/ IOS smartphone and internet connectivity available for tracking his vital parameters
3.Willing to track their own progress through the app
|
|
| ExclusionCriteria |
| Details |
1.People reluctant to track their progress
2.People not comfortable with using mobile phone app for tracking their disease
3.People not willing to be a part of the study
4.People with known infections or other factors that might hamper glycemic control.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - FBS/ PPBS/ HbA1c |
3months, 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Body weight and BMI
-Insulin and OHA requirement per day
-New complications if any
-Compliance to medication, visit and investigation schedule advised
-Patient drop- out rate
|
3 months, 6 months |
|
|
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)
|
24/04/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this
fast evolving world of digital technologies, chronic disease care is also
poised for a revolution. In the field of diabetes care also several studies
have shown that mobile phone interventions led to statistically significant
improvement in glycemic control and self- management of the disease. The current study has been designed to study the efficacy of a digital paltform in achieving better glycemic control. TYpe 2 diabetics in age group 18-55 years with HbA1c >8.5% will be divided into two groups. One group will receive diet advice and mefication during OPD visit and followed up at 3 & 6 months. Second group will receive diet advice, medication, proprietary mobile app "Lifeincontrol" for self menagement and data driven diabetes coaching and followed up at 3 & 6 months. The outcomes between two groups will be compared.
|