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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60203274

Enrollment

106

Registered

2018-01-23

Start date

2018-02-02

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes Pregnancy and Childbirth Diabetes mellitus arising in pregnancy

Interventions

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-mon

Eligibility

Sex/Gender

Female

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026