4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Dietary Supplement: diabetic diet

• Registration Number: NCT04101396
• Lead Sponsor: National University of Malaysia

Brief Summary

This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.

Detailed Description

All women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the pregnancy outcomes will be evaluated.

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-21
• Study First Posted: 2019-09-24
• Study Start: 2019-10-25
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Aged 18-45 years old
• Pregnant women with gestational diabetes mellitus on diet modification
• Confirmed gestational diabetes mellitus using National Institute for Health and Care Excellence guideline by 75g oral glucose tolerance test after 14 weeks
• Gestational age at recruitment 20-34 week

Exclusion Criteria

• bad obstetrics history.
• Women with underlying medical disorders such as hypertension, autoimmune diseases on steroids
• fetal anomaly.
• Women planning to deliver in other centres
• Women who refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7 points blood glucose monitoring	diabetic diet	7 points of self monitoring blood glucose which comprises of fasting,1 hour post breakfast, 1 hour pre and post lunch, 1 hour pre and post dinner, pre bed at 10 pm
4 points blood glucose monitoring	diabetic diet	4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner

Primary Outcome Measures

Name	Time	Method
Clinical characteristics of participants	At the point of randomisation till 40 weeks gestation	Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l
Pregnancy outcome of participants	From date of randomisation up to 7 days after birth of the neonate	Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage
Demographic data of participants	On the date of randomisation up to 40 weeks gestation	Rate of previous pregnancy complicated by fetal macrosomia in percentage

Secondary Outcome Measures

Name	Time	Method
Participants' satisfaction	From point of randomisation till 40 weeks gestation	Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage
Requirement of treatment in participants	From point of randomisation till 40 weeks gestation	Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent
Participants' compliance	From point of randomisation till 40 weeks gestation	Rate of frequency of four weekly self blood glucose monitoring in percentage

Trial Locations

Locations (2)

Antenatal clinic, UKM Medical Centre; 🇲🇾 Cheras, Kuala Lumpur, Malaysia

National University of Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia