| CTRI Number |
CTRI/2025/03/081818 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving diabetes management- using continuous blood glucose control and personalised diet recommendations |
|
Scientific Title of Study
|
ADAM: Advancing DiAbetes Management- Integration of Continuous Glucose Monitoring with Artificial Intelligence for Personalized Diet Interventions in Diabetes |
| Trial Acronym |
ADAM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali T M Ollapally |
| Designation |
Associate professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Dept of Anaesthesiology
St Johns Medical College Hospital
Bangalore
KARNATAKA
560034
India |
| Phone |
9886474530 |
| Fax |
|
| Email |
anjali.tm@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali T M Ollapally |
| Designation |
Associate professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Dept of Anaesthesiology
St Johns Medical College Hospital
KARNATAKA
560034
India |
| Phone |
9886474530 |
| Fax |
|
| Email |
anjali.tm@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Anjali T M Ollapally |
| Designation |
Associate professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Dept of Anaesthesiology
St Johns Medical College Hospital
KARNATAKA
560034
India |
| Phone |
9886474530 |
| Fax |
|
| Email |
anjali.tm@stjohns.in |
|
|
Source of Monetary or Material Support
|
| ICMR extramural small grant |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research, V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi - 110029, India, Ph: 91-11-26588895 |
| Type of Sponsor |
Government funding agency |
|
|
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 Anjali T M Ollapally |
St Johns medical college hospital |
no2 dept of medicine opd
Bangalore
KARNATAKA |
9886474530
anjali.tm@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns medical college institutional ethics committee |
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 |
digital diet optimisation and recommendation software |
In phase 2, diet recommendations of a human dietician and a virtual dietician are compared based on blood glucose levels |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus on treatment with the same oral hypoglycemic agents for 3 months |
|
| ExclusionCriteria |
| Details |
patients with kidney disease
patients with liver disease
patients with any acute illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase 1-an optimization model will be developed to formulate dietary management guidelines aimed at achieving balanced glucose levels.
Phase 2-The efficacy of the Virtual Dietician based intervention and Change in BMI, QoL and onset or change in neuropathy symptoms. |
Phase 1-an optimization model will be developed to formulate dietary management guidelines aimed at achieving balanced glucose levels.
Phase 2-The efficacy of the Virtual Dietician based intervention . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in BMI, quality of life and neuropathy symptoms |
3 months |
|
|
Target Sample Size
|
Total Sample Size="221"
Sample Size from India="221"
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)
|
01/04/2025 |
| 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="3"
Months="0"
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
|
In 2021, global diabetes prevalence was 6.1%, projected to
reach 10% by 2050 (1)Lifestyle management, including diet, is crucial in
diabetes management(2). While carbohydrate restriction shows promise for
glycemic control, practical implementation remains a challenge, especially in
India.
NOVELTY: This study
seeks to integrate cutting-edge technologies by combining continuous glucose
monitoring (CGM) with an AI-powered Virtual Dietician (VD) to offer real-time
personalized feedback and dietary advice, aiming to bridge the gap between
clinical evidence and practical implementation in Type 2 DM management
Objectives:
1.
Assessing the blood glucose response to a
carbohydrate-restricted diet among Indian diabetes patients on oral
hypoglycemic agents (OHA) to refine the diet tool
2.
Evaluating the effectiveness of the AI Virtual
Dietician in providing personalized dietary advice to achieve higher time in
range (TIR) compared to usual care.
Methods :The study comprises two phases:
Phase 1 involves a longitudinal study on Type
2 DM patients aged 18-65. CGM devices will monitor blood glucose for 14 days,
while dietary recall will be conducted using the Virtual Dietician app. Results
will inform modifications to the VD’s diet optimization tool to enhance glucose
control and prevent hypoglycemia while meeting personalized micronutrient
requirements.
Phase 2 consists of an (RCT) comparing Usual
Care to Enhanced Care groups, both using CGM. The Enhanced Care group will
additionally receive the AI-based Virtual Dietician app for personalized
dietary recommendations based on phase 1 optimizations.
Outcomes:
1
Differences in average blood glucose and TIR between groups, changes in HbA1c,
BMI, Quality of Life (QoL), and neuropathy symptoms.
|