| CTRI Number |
CTRI/2018/08/015530 [Registered on: 30/08/2018] Trial Registered Prospectively |
| Last Modified On: |
27/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Data-driven Coaching Intervention in Achieving Glycemic Control in Uncontrolled Type II Diabetics |
|
Scientific Title of Study
|
Study to Evaluate 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 |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paramesh Shamanna |
| Designation |
Director |
| Affiliation |
Karnataka Medical Council |
| Address |
no. 426, 4thcross, 2nd block, Kalyan nagar, Bengaluru, Karnataka 560043
Bangalore
KARNATAKA
560043
India |
| Phone |
9845010610 |
| Fax |
|
| Email |
drparamesh2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Partha Sarathi Pati |
| Designation |
Cheif product officer |
| Affiliation |
CURO Health Services |
| Address |
805, Millenium Plaza Towers, Shushant Lok 1, Gurugram, haryana
Bangalore
KARNATAKA
122002
India |
| Phone |
9958398699 |
| Fax |
|
| Email |
Partha@lifeincontrol.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar |
| Designation |
Professor of Biostatistics |
| Affiliation |
Bapuji Dental College and hospital, Davangere-577004 |
| Address |
MCC B block, MCC, Davangere, Karnataka 577004
Bangalore
KARNATAKA
577004
India |
| Phone |
8050558443 |
| Fax |
|
| Email |
arun.biostat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Curo Healthcare
805, Millenium Plaza Towers, Sushant Lok 1, Gurugram, Haryana 122002 |
|
|
Primary Sponsor
|
| Name |
Curo Healthcare |
| Address |
805, Millenium Plaza Towers, Sushant Lok1, Gurugram, Haryana 122002 |
| Type of Sponsor |
Other [Curo Healthcare Technologies Private limited] |
|
|
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 Arun Kumar |
Bangalore Diabetic centre |
Clinical Research Unit
No.426, 4th Cross, 2nd Block, Kalyan Nagar, Bengaluru, Karnataka 560043
Bangalore
KARNATAKA |
8050558443
arun.biostat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medisys Clinisearch Ethical review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Type 2 diabetes mellitus |
40 Subjects on Keto diet
40 Subjects on Normal T2DM diet |
| Comparator Agent |
Type 2 diabetes mellitus |
40 Subjects on Keto diet 40 Subjects on Normal T2DM diet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type II Diabetes Mellitus subjects of either sex aged 18 to 65years.
HbA1c value greater than 7.0%.
Subjects able to provide written informed consent.
Subjects using android mobile.
Agree to follow Keto/T2DM diet and use Keto calculator app.
If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the study.
|
|
| ExclusionCriteria |
| Details |
Subjects with deteriorating health status at the time of enrolment; rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhoea, gastro-intestinal disease, irritable bowel syndrome).
Recent blood donation (within 3 months from the date of screening).
Immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection).
Pregnant or breast feeding women.
Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
Any contraindication to blood sampling.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the glycaemic levels (HbA1c, FBG, PPBG) in uncontrolled type II diabetes patients being managed by conventional treatment compared to those being managed nutritional ketosis using a connected digital health platform |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare weight loss, Body mass index changes, Insulin and medication requirement, compliance to prescribed medication, visit and lab test schedule between the above two groups at the end of a three-month period |
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2018 |
| 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
|
Planning to publish result of this trial in a indexed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Type II Diabetes is a lifestyle related
disease that is fast becoming an epidemic in India with 69.1 million affected
people in 20151.
With a cost of 94.9 USD per person1
this disease is poised to become a big economic burden for the not only
individuals but also society at large. Achieving better glycaemic control and
avoiding complications remains one of the most relevant goals of any diabetes
management program. 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 glycaemic control and self- management
program. Despite advances in treatment of diabetes
like novel drugs and insulin analogues for the treatment of diabetes, the
complications that arise due to diabetes have not reduced. Diet is one of the
most crucial elements in the management of diabetes. Nutritional ketosis as a
dietary intervention has shown promise to help with diabetes control. But
following through with a keto diet requires constant support from a
multidisciplinary team of clinical nutritionists and medical doctors for it to
be adequately safe. Connected digital technology has been shown to improve care
coordination and provide a continuum of care while making real-time data
available for decision making. Through this study, we evaluate if a structured
nutritional ketosis program delivered through a digital health platform is
effective in reducing HbA1c.
|