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

NCT04101396 | Completed DMC

• 1 other identifier: FF-2019-351
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

diet modification, 4 and 7 points monitoring

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (4)

• Requirement of treatment in participants

  From the date of randomisation up to 40 weeks gestation

• Requirement of treatment in participants

  From point of randomisation till 40 weeks gestation

• Participants' compliance

  From point of randomisation till 40 weeks gestation

• Participants' satisfaction

  From point of randomisation till 40 weeks gestation

Study Arms (2)

4 points blood glucose monitoring

OTHER

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

7 points blood glucose monitoring

OTHER

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

Interventions

diabetic diet DIETARY_SUPPLEMENT

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

4 points blood glucose monitoring; 7 points blood glucose monitoring

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (2)

Antenatal clinic, UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 39110209 DERIVED

MeSH Terms

Interventions

Diet, Diabetic

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Noor Dalila Berohan

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

• Norasyikin Abd Wahab

  National University of Malaysia

  STUDY DIRECTOR

• Shuhaila Ahmad

  National University of Malaysia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 24, 2019
• Study Start: October 25, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)