| CTRI Number |
CTRI/2024/07/071323 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate whether personalized dietary and physical activity advice based on CGMS data would be effective in preventing the occurrence of gestational diabetes mellitus in high risk women. |
|
Scientific Title of Study
|
Evaluating the utility of continuous glucose monitoring system for behavioral modification in high risk women enrolled in early pregnancy for the prevention of gestational diabetes mellitus a pilot Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashdeep Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No-3074, Teaching Block, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9999598468 |
| Fax |
|
| Email |
yash_deep_gupta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakansha |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No-3074, Teaching Block, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9650746218 |
| Fax |
|
| Email |
aakansha.0701@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashdeep Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No-3074, Teaching Block, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9999598468 |
| Fax |
|
| Email |
yash_deep_gupta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
Dr Yashdeep Gupta |
| Address |
Room No-3074, Teaching Block, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi-110029, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Yashdeep Gupta |
All India Institute of Medical Sciences |
C-wing, New Rajkumari OPD, Department of Endocrinology and Metabolism, New Delhi-110029
South
DELHI |
9999598468
yash_deep_gupta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
High-risk women in early pregnancy with period of gestation less than 14 weeks |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous Glucose Monitoring System |
Women allocated to intervention arm will undergo 2 weeks of continuous glucose monitoring and will be asked to record (take photos) of all that they take in diet and record the timing and duration of dedicated physical activity. The impact of diet and physical activity on glycaemia will be understood through CGMS which records 96 glucose values per day and provides response to individual meal.
Standardized CGM metrics as per the 2019 International Consensus on CGM metrics will be noted.
After detailed interpretation of diet, physical activity, and CGMS data, individualized diet and physical activity advice will be given.
CGMS insertion and tailored dietary and physical activity advice will also be repeated between 24-28 weeks gestation. |
| Comparator Agent |
Usual care |
Women in the control arm will be given a diet chart prepared by a dietician and given physical activity advice as part of usual care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women 18 years or older in early pregnancy with period of gestation less than 14 weeks. The participant should have one or more risk factors for gestational diabetes mellitus. The patient should have a BMI more than equal to 25 kilogram per meter square or BMI more than or equal to 23 Kilogram per meter square with hypertension or history of PCOS or previous history of gestational diabetes mellitus or family history of diabetes in first degree relative or age more than 35 years. The patient should have a singleton pregnancy confirmed by ultrasonography and should be enrolled either in the Department of Endocrinology and Metabolism or Department of Obstetrics and Gynaecology AIIMS Delhi. The participant should also be willing to comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
Women with Type 1 diabetes mellitus secondary diabetes or overt and pre-existing diabetes or gestational diabetes defined as per WHO 2019 criteria. The participant should not have any systemic illness with major organ dysfunction and should not be on steroids. Women with eczema or with a skin condition which precludes using a continuous glucose monitoring device will also be excluded. Women who do not have a smartphone as diet pictures have to be shared on real time basis.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the incidence of gestational diabetes mellitus between the intervention and control groups |
At 28 weeks period of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in between the two groups in appropriate gestational weight gain both total and per week. |
At baseline, between 24 to 28 weeks period of gestation, between 34-38 weeks period of gestation and at delivery. |
Difference in composite pregnancy outcome which will be a composite of neonate born large for gestational age
gestational hypertension or pre-eclampsia, small for gestational age, Apgar score less than 7, hyperbilirubinemia, respiratory distress syndrome, clinically significant neonatal hypoglycemia, preterm birth, perinatal mortality, NICU admission for more than 24 hours
|
At delivery |
| Percentage of women who wore CGMS for the entire duration of two weeks |
At baseline and between 24 to 28 weeks period of gestation |
| Percentage of women who shared the data of their diet for at least 70% of their meals |
At baseline and between 24 to 28 weeks period of gestation |
| Percentage of women who scanned periodically and provided more than 70% of the CGMS data |
At baseline and between 24 to 28 weeks period of gestation |
| Percentage of women adherent to all six assessment visits. |
At delivery. |
| Participant satisfaction with full intervention process |
At delivery |
| Perceived benefit of tailored behavioral modification advice by the participant |
At delivery |
| Participant satisfaction with the use of CGMS |
At baseline and between 24-28 weeks |
| Likely recommendation for use in other pregnant women by the participant |
At delivery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 this study we wish to evaluate the utility of tailored behavioral modification based on information provided by a continuous glucose monitoring device compared to usual care in which participants will be given a diet chart and advised physical activity. We wish to see the difference between the incidence of gestational diabetes mellitus in between these two groups as well as observe the differences between various maternal and neonatal outcomes. |