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

4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial

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

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Dietary supplement: diabetic diet

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nor Azlin Mohamed Ismail; Phone Number: +60193122255; Email: azlinm@ppukm.ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • National University of Malaysia
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Antenatal clinic, UKM Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Dietary supplement: diabetic diet; Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
Other: 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	Dietary supplement: diabetic diet; Patients with gestational diabetes will be seen by the dietitian to be taught diet modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy outcome of participants	Mean gestational age at delivery in weeks	From date of randomisation up to 40 weeks gestation
Pregnancy outcome of participants	Rate of spontaneous or induced labour in percentage	From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
Pregnancy outcome of participants	Rate of vaginal, instrumental or caesarean delivery in percentage	From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
Pregnancy outcome of participants	Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage	From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
Pregnancy outcome of participants	Mean neonatal birth weight in kilogram	At the point of birth of the neonate
Pregnancy outcome of participants	Rate of neonates born with Apgar score at five minutes of less than 7 in percentage	At the point of birth of the neonate
Pregnancy outcome of participants	Rate of neonatal intensive care unit admission in percentage	At the point of birth of the neonate
Pregnancy outcome of participants	Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage	From date of randomisation up to 7 days after birth of the neonate
Demographic data of participants	Mean age of participants in years	On the date of randomisation
Demographic data of participants	Rate of each different races such as Malay, Chinese and Indian in percentage	On the date of randomisation
Demographic data of participants	Rate of parity such as nulliparous or multiparous in percentage	On the date of randomisation
Demographic data of participants	Mean prepregnancy body mass index in kg/m^2	On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record
Demographic data of participants	Mean total weight gain in kilogram	On the date of randomisation till 40 weeks gestation
Demographic data of participants	Rate of positive family history of diabetes mellitus in percentage	On the date of randomisation up to 40 weeks gestation
Demographic data of participants	Rate of previous pregnancy affected by gestational diabetes mellitus in percentage	On the date of randomisation up to 40 weeks gestation
Demographic data of participants	Rate of previous pregnancy complicated by fetal macrosomia in percentage	On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants	Mean gestational age gestational diabetes mellitus is diagnosed in weeks	On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants	Mean fasting glucose level from the modified glucose tolerance test in mmol/l	On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants	Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l	On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants	Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,	At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants	Mean level of glycosylated haemoglobin in percentage	At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants	Mean level of serum fructosamine in percentage	At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants	Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l	At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants	Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l	At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants	Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l	At the point of randomisation till 40 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Requirement of treatment in participants	Mean gestational age that the participants are detected to require added treatment in weeks	From the date of randomisation up to 40 weeks gestation
Requirement of treatment in participants	Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent	From point of randomisation till 40 weeks gestation
Participants' compliance	Rate of frequency of four weekly self blood glucose monitoring in percentage	From point of randomisation till 40 weeks gestation
Participants' satisfaction	Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage	From point of randomisation till 40 weeks gestation

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: Noor Dalila Berohan, National University of Malaysia; Study Director: Norasyikin Abd Wahab, National University of Malaysia; Study Chair: Shuhaila Ahmad, National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 21, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: diet modification, 4 and 7 points monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: FF-2019-351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will only be shared upon request. The data that can be shared will be the blood glucose levels and pregnancy outcomes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No