A clinical trial to study time in percentage of gestational diabetes patient glucose levels which remains within the proposed target range using a continuous glucose monitoring device with insulin or metformin.
Not Applicable
- Conditions
- Health Condition 1: O244- Gestational diabetes mellitus
- Registration Number
- CTRI/2023/09/057976
- Lead Sponsor
- Dr Abhishek Pandey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Gestation age 12-30 weeks
Singleton pregnancy
Confirmed GDM (75g oral glucose tolerance test: fasting plasma glucose = 92 mg/dl, 1-hr glucose 180 mg/dl, and/or 2-h glucose =153 mg/dl) IADPSG criteria (The International Association of the Diabetes and Pregnancy Study Groups)
Exclusion Criteria
Pre-gestational Type 1 or Type 2 diabetes
Newly diagnosed overt diabetes in pregnancy [HbA1c = (6.5%), fasting glucose = 126 mg/dl, random glucose = 200 mg/dl]
Endocrine conditions leading to Hyperglycemia
Known chronic infections
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The hypothesis being tested is- <br/ ><br>A gestational Diabetes Mellitus woman receiving metformin is not inferior to a gestational diabetes mellitus woman receiving insulin among in maintaining the Time in Range levels (TIR) <br/ ><br>Primary Objective: <br/ ><br>1. To compare Continuous Glucose Monitoring derived Time in Range in women with gestational diabetes mellitus treated with metformin or insulin <br/ ><br> <br/ ><br>Timepoint: 14 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary Objective: <br/ ><br>1. To compare CGM-derived glycemic variability indices apart from Time in Range in women with gestational diabetes mellitus treated with metformin or insulin <br/ ><br>Timepoint: 14 days