Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID05326204

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

Led by National University of Malaysia · Updated on 2025-06-12

2954

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness of monitoring blood sugar levels at 1 hour versus 2 hours after meals in pregnant women diagnosed with Gestational Diabetes Mellitus who require treatment. The study focuses on understanding which monitoring time better supports managing blood sugar during pregnancy to improve outcomes for both mother and baby. Participants are pregnant women attending an antenatal clinic and are treated with metformin, insulin, or a combination. Participants will be randomly assigned to monitor their blood sugar either 1 hour or 2 hours after meals using self-monitoring of capillary blood glucose. Their blood sugar is tracked at seven staggered points to provide a detailed profile. This monitoring continues until delivery, with participants followed regularly in the research clinic. Throughout the study, women will have regular visits to assess their health and that of their baby. Researchers will collect data on mode of delivery, gestational age at birth, and fetal weight. They will also monitor maternal and perinatal complications from randomization to delivery. The total participation lasts from enrollment until the birth of the baby, allowing detailed observation of pregnancy outcomes related to the glucose monitoring method.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational diabetes diagnosed based on National Institute for Health and Care Excellence guideline
  • Requiring treatment with metformin alone or combined with insulin
  • Female participants aged 18 to 45 years
  • Pregnant women attending antenatal clinic
Not Eligible

You will not qualify if you...

  • Type 1 and type 2 diabetes
  • History of serious pregnancy complications (bad obstetrics history)
  • Underlying medical disorders such as Systemic Lupus Erythematosus
  • Presence of fetal anomaly
  • Delivery planned elsewhere

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From randomization until delivery (approximately several weeks to months depending on gestational age)

Participants perform self-monitoring of blood glucose at home either 1 or 2 hours post meal as assigned, with staggered 7 point blood sugar profiles, and are followed in the research clinic until delivery.

Regular follow-up visits in the research clinic until delivery

Trial Site Locations

Total: 1 location

1

UKM Medical Center

Kuala Lumpur, W.Persekutuan, Malaysia, 56000

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Research Team

R

Rahana Abd Rahman

A

Aida Hani Kalok

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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