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

June 9, 2025 updated by: National University of Malaysia

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Estimated)

2954

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • W.Persekutuan
      • Kuala Lumpur, W.Persekutuan, Malaysia, 56000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All women with gestational diabetes on treatment attending the antenatal clinic in our centre

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 hour
Blood glucose monitoring comprises of 1 hour post meal
Other: Home blood glucose monitoring
Self monitoring of capillary blood glucose
2 hours
Blood glucose monitoring comprises of 2 hours post meal
Other: Home blood glucose monitoring
Self monitoring of capillary blood glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: from point of randomization to birth of the neonate
route
from point of randomization to birth of the neonate
Gestational age
Time Frame: from point of randomization to birth of the neonate
in weeks
from point of randomization to birth of the neonate
Fetal weight
Time Frame: from point of randomization to birth of the neonate
in gram
from point of randomization to birth of the neonate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal complications
Time Frame: from point of randomization to birth of the neonate
postpartum haemorrhage, perineal tear
from point of randomization to birth of the neonate
perinatal complications
Time Frame: from point of randomization to birth of the neonate
intrauterine death, macrosomia, admission to neonatal intensive care unit
from point of randomization to birth of the neonate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Rahana Abd Rahman, National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2021

Primary Completion (Estimated)

December 29, 2025

Study Completion (Estimated)

December 29, 2025

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2022-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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