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

NCT ID: NCT04101396

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gestational Diabetes Mellitus in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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4 points blood glucose monitoring

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

Group Type OTHER

diabetic diet

Intervention Type DIETARY_SUPPLEMENT

Patients with gestational diabetes will be seen by the dietitian to be taught diet modification

7 points blood glucose monitoring

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

Group Type OTHER

diabetic diet

Intervention Type DIETARY_SUPPLEMENT

Patients with gestational diabetes will be seen by the dietitian to be taught diet modification

Interventions

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diabetic diet

Patients with gestational diabetes will be seen by the dietitian to be taught diet modification

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Rahana Abd Rahman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noor Dalila Berohan

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Norasyikin Abd Wahab

Role: STUDY_DIRECTOR

National University of Malaysia

Shuhaila Ahmad

Role: STUDY_CHAIR

National University of Malaysia

Locations

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Antenatal clinic, UKM Medical Centre

Cheras, Kuala Lumpur, Malaysia

Site Status

National University of Malaysia

Cheras, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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Berohan ND, Alias H, Ishak S, Mohammed Nawi A, Azman N, Sohaimi D, Kamisan Atan I, Abd Wahab N, Kalok AH, Mohamad AS, Abd Rahman R. 4 vs 7 points self-monitoring blood glucose in gestational diabetes mellitus on diet modification: randomised clinical trial in a single tertiary centre in Malaysia. Arch Gynecol Obstet. 2024 Oct;310(4):1959-1965. doi: 10.1007/s00404-024-07661-5. Epub 2024 Aug 7.

Reference Type DERIVED
PMID: 39110209 (View on PubMed)

Other Identifiers

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FF-2019-351

Identifier Type: -

Identifier Source: org_study_id

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