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

NCT05326204 | Recruiting

• 1 other identifier: FF-2022-002
• Study Type: observational
• Target: 2,954
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes; Treatment Adherence

Keywords

Gestational diabetes; treatment; glucose monitoring

Outcome Measures

Primary Outcomes (3)

• Mode of delivery

  route

  from point of randomization to birth of the neonate

• Gestational age

  in weeks

  from point of randomization to birth of the neonate

• Fetal weight

  in gram

  from point of randomization to birth of the neonate

Secondary Outcomes (2)

• Maternal complications

  from point of randomization to birth of the neonate

• perinatal complications

  from point of randomization to birth of the neonate

Study Arms (2)

1 hour

Blood glucose monitoring comprises of 1 hour post meal

Other: Home blood glucose monitoring

2 hours

Blood glucose monitoring comprises of 2 hours post meal

Other: Home blood glucose monitoring

Interventions

Home blood glucose monitoring OTHER

Self monitoring of capillary blood glucose

1 hour; 2 hours

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

UKM Medical Center

Kuala Lumpur, W.Persekutuan, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Treatment Adherence and Compliance

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Rahana Abd Rahman

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahana Abd Rahman

CONTACT

+60122719985; drrahana@ppukm.ukm.edu.my

Aida Hani Kalok

CONTACT

+60122024091; aidahani.mohdkalok@ppukm.ukm.edu.my

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: December 30, 2021
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)