1 Versus 2 Hours Post Meal Glucose Monitoring in Gestational Diabetes on Treatment

Recruiting

• Conditions: Gestational Diabetes; Treatment Adherence

• Registration Number: NCT05326204
• Lead Sponsor: National University of Malaysia

Brief Summary

A study to compare between 1 and 2 hours post meal blood glucose monitoring in patients with Gestational Diabetes Mellitus requiring treatment.

Detailed Description

This study involves all pregnant women who attended our antenatal clinic with Gestational Diabetes Mellitus requiring treatment. They will be randomised to either 1 or 2 hours post meal self blood glucose monitoring. The blood sugar profile is a staggered 7 points. They are followed up in the research clinic until delivery.

Study Timeline

• Study Start: 2021-12-30
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-12-29
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2954

Inclusion Criteria

• Gestational diabetes diagnosed based on National Institute for Health and Care Excellence guideline
• requiring treatment either with metformin alone or combined with insulin

Exclusion Criteria

• type 1 and 2 diabetes
• bad obstetrics history
• underlying medical disorders such as Systemic Lupus Erythematosus
• fetal anomaly
• delivery elsewhere

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal weight	from point of randomization to birth of the neonate	in gram
Gestational age	from point of randomization to birth of the neonate	in weeks
Mode of delivery	from point of randomization to birth of the neonate	route

Secondary Outcome Measures

Name	Time	Method
perinatal complications	from point of randomization to birth of the neonate	intrauterine death, macrosomia, admission to neonatal intensive care unit
Maternal complications	from point of randomization to birth of the neonate	postpartum haemorrhage, perineal tear

Trial Locations

Locations (1)

UKM Medical Center; 🇲🇾 Kuala Lumpur, W.Persekutuan, Malaysia