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Recruiting NCT05326204

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

Observational Gestational Diabetes Treatment Adherence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home blood glucose monitoring.
Who it may be relevant to
Registry conditions: Gestational Diabetes, Treatment Adherence. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Mode of delivery [Time frame: from point of randomization to birth of the neonate]
  • Gestational age [Time frame: from point of randomization to birth of the neonate]
  • Fetal weight [Time frame: from point of randomization to birth of the neonate]
Secondary outcome measures (2)
  • Maternal complications [Time frame: from point of randomization to birth of the neonate]
  • perinatal complications [Time frame: from point of randomization to birth of the neonate]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Malaysia · 1 center
  • UKM Medical Center — Kuala Lumpur

Identifiers

NCT: NCT05326204 · FF-2022-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗