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

Gestational Diabetes Clinical Trial

Official title:

1 Versus 2 Hours Post Meal Self Monitoring Blood Glucose in Gestational Diabetes Mellitus on Treatment-A Prospective Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326204
• Other study ID #: FF-2022-002
• Status: Recruiting
• Start date: December 30, 2021
• Est. completion date: December 29, 2025

Study information

• Verified date: January 2024
• Source: National University of Malaysia
• Contact: Rahana Abd Rahman
• Phone: +60122719985
• Email: drrahana[@]ppukm.ukm.edu.my
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2954
• Est. completion date: December 29, 2025
• Est. primary completion date: December 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Treatment Adherence

Intervention

Other:
• Home blood glucose monitoring
Self monitoring of capillary blood glucose

Locations

Country	Name	City	State
Malaysia	UKM Medical Center	Kuala Lumpur	W.Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mode of delivery	route	from point of randomization to birth of the neonate
Primary	Gestational age	in weeks	from point of randomization to birth of the neonate
Primary	Fetal weight	in gram	from point of randomization to birth of the neonate
Secondary	Maternal complications	postpartum haemorrhage, perineal tear	from point of randomization to birth of the neonate
Secondary	perinatal complications	intrauterine death, macrosomia, admission to neonatal intensive care unit	from point of randomization to birth of the neonate