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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.

Time in Range with Insulin versus Metformin in Gestational Diabetes Mellitus using Continuous Glucose Monitoring: A Randomized Control Study at Tertiary Care Centre in Southern India - TIRIMGDM Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057976
Enrollment
44
Registered
2023-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Intervention1: Metformin: Metformin will be started at a dose of 500 mg once or twice daily with food and increased, typically over a period of 1 to 2 weeks, to meet glycemic targets up to maximum da

Sponsors

Dr Abhishek Pandey
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The hypothesis being tested is- 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) Primary Objective: 1. To compare Continuous Glucose Monitoring derived Time in Range in women with gestational diabetes mellitus treated with metformin or insulin Timepoint: 14 days—

Secondary

MeasureTime frame
Secondary Objective: 1. To compare CGM-derived glycemic variability indices apart from Time in Range in women with gestational diabetes mellitus treated with metformin or insulin Timepoint: 14 days—

Countries

India

Contacts

Public ContactDr Abhishek Pandey

Sapthagiri Institute of Medical Sciences and Research Centre

shvprsd.c@gmail.com9900021320

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026