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

National University of Malaysia

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Dietary Supplement: diabetic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04101396

FF-2019-351

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

4 points blood glucose monitoring

Other group

Description:

4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner

Treatment:

Dietary Supplement: diabetic diet

7 points blood glucose monitoring

Other group

Description:

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

Treatment:

Dietary Supplement: diabetic diet