Self-monitoring of blood glucose of three days compared to one day per week in mild gestational diabetes

• Register: ISRCTN
• Last refreshed on: 13 March 2023
• Main ID: ISRCTN60203274
• Date of registration: 23/01/2018
• Prospective Registration: Yes
• Primary sponsor: University Malaya Medical Centre
• Public title: Self-monitoring of blood glucose of three days compared to one day per week in mild gestational diabetes
• Scientific title: Self-monitoring of blood glucose of three days compared to one day per week in mild gestational diabetes: a randomised trial
• Date of first enrolment: 02/02/2018
• Target sample size: 106
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN60203274
• Study type: Interventional
• Study design: Open-label randomised trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Malaysia

Contacts

• Name: Ahmad Firdzaus Mohd Noor

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 to 45
2. Singleton pregnancy
3. Gestational age at recruitment 20-30 weeks
4. Confirmed GDM: Fasting plasma glucose = 5.1 mmol/L and/or the 2-hour = 7.8 mmol/L by 75g OGTT = 16 weeks of pregnancy
5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial = 5.3, post prandial 1 hour of = 7.8 or post prandial 2 hours of = 6.7 mmol/L
6. Not on any hypoglycaemic drug treatment

Exclusion criteria:
1. History of prepregnant hyperglycaemia (type 2 diabetes, impaired glucose tolerance or fasting glycaemia)
2. Fasting plasma glucose = 7.0 and/or the 2-hour level = 11.1 mmol/L by 75g OGTT
3. Haemoglobin level of < 8
4. Medical condition likely to result in delivery before 36 weeks gestation
5. Planning to deliver in different hospital from UMMC


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Gestational diabetes
Pregnancy and Childbirth
Diabetes mellitus arising in pregnancy

Intervention(s)

Randomisation sequence will be generated in random blocks of 4 or 8 using a random number generator by a co-investigator who is not involved in recruitment. Participants will be randomised to self-monitoring of blood glucose using a personal blood glucose monitor 4 time points per day (i.e. when still fasted before breakfast, 2 hours after breakfast, lunch and dinner) for either:
1. 3 days per week (on 2 week days and 1 weekend day each week)
2. 1 day per week (on a week day or a weekend day on alternate weeks)

Patients will be under intervention and follow up from recruitment and until delivery.

Primary Outcome(s)

HbA1c level, measured using blood sample taken and sent to haematology labarotory in UMMC at recruitment and at 36 weeks

Secondary Outcome(s)

1. Drug treatment (e.g. metformin, insulin) during follow up
2. Pregnancy induced hypertension (BP = 140 sys or 90 diastolic on 2 occasions prior to labour > 6 hours apart) during follow up
3. Gestational age at delivery
4. Induction of labor with indication
5. Epidural analgesia in labour
6. Mode of delivery:
6.1. Spontaneous vertex delivery
6.2. Instrumental delivery
6.3. Caesarean section with indication
7. Delivery estimated blood loss (major primary postpartum hemorrhage > 1000 ml)
8. Third/fourth degree tear
9. Placenta weight
10. Birth weight
11. Umbilical cord arterial pH at birth
12. Apgar score at 1st and 5th minutes
13. Special care nursery/neonatal intensive care unit admission during birth admission, indications of admission

3 to 13: the outcomes will be measured after delivery

Secondary ID(s)

2017104-5626

Source(s) of Monetary Support

Department of Obstetrics and Gynaecology Support for Research Funding

Ethics review

Status:
Approval date:
Contact:

Medical Research Ethics Committee, University Malaya Medical Centre, 29/11/2017, ref: MREC ID NO: 2017104-5626

Results

• Results available: Yes
• Date Completed: 31/12/2018