Self-monitoring of blood sugar level in mild gestational diabetes: weekly compared to every 2 weeks

Weekly compared to two weekly self-monitoring of blood glucose in mild gestational diabetes: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13404790

Enrollment

100

Registered

2022-03-25

Start date

2022-04-12

Completion date

Unknown

Last updated

2023-06-05

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

Conditions

Mild gestational diabetes Pregnancy and Childbirth Diabetes mellitus arising in pregnancy

Interventions

Participants will be randomized in a 1:1 ratio to weekly or two weekly self-monitoring of blood glucose (SMBG): 1. One day per week of four-point (fasting/prebreakfast and 2 hours afte

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. 75-g oral glucose tolerance test in pregnancy with fasting = 5.1 mmol/l and/or 2-hour = 8.5 mmol/l 2. Gestational age 24-32 weeks at recruitment 3. Aged =18 years old 3. Singleton viable pregnancy 4. Normal four-point blood sugar profile from self-monitoring of blood glucose in the preceding 2 weeks (fasting/pre-prandial = 5.3, post-prandial 1 hour = 7.8 or post-prandial 2 hours = 6.7 mmol/l)

Exclusion criteria

Exclusion criteria: 1. Anti-glycemic drug treatment 2. Prepregnancy hyperglycaemia (type 1 or 2 diabetes, impaired glucose tolerance or fasting glycaemia) 3. 75-g oral glucose tolerance test in pregnancy fasting plasma glucose = 7.0 and/or the 2-hour level = 11.1 mmol/l 4. Anaemia (haemoglobin level of <8 g/dl) 5. Medical condition likely to result in delivery before 36 weeks gestation

Design outcomes

Primary

Measure	Time frame
Blood sugar control measured using glycated haemoglobin (HbA1c) level at enrolment to 36 weeks gestation	—

Secondary

Measure	Time frame
1. Maternal outcomes assessed by reviewing patient’s notes after delivery: 1.1. Gestational age at delivery 1.2. Maternal weight at delivery 1.3. Maternal weight gain 1.4. Need for antiglycemic agent (e.g., metformin, insulin) 1.5. Induction of labor 1.6. Mode of delivery 1.7. Epidural analgesia for labor 1.8. Indication for cesarean delivery 1.9. Delivery blood loss 1.10. Shoulder dystocia 1.11. Third- or fourth-degree tear 1.12. Placenta weight 2. Neonatal outcomes assessed by reviewing patient’s and baby’s notes after delivery: 2.1. Birth weight (low birth weight 3.5 kg) 2.2. Umbilical cord arterial pH and base excess at birth 2.3. Apgar score at 1 and 5 minutes 2.4. Neonatal hypoglycemia 2.5. Neonatal birth injury (e.g., Erbs palsy, bone fracture, cephalhematoma etc) 2.6. Special care nursery/neonatal intensive care unit admission and indication	—

Measure

Time frame

1. Maternal outcomes assessed by reviewing patient’s notes after delivery: 1.1. Gestational age at delivery 1.2. Maternal weight at delivery 1.3. Maternal weight gain 1.4. Need for antiglycemic agent (e.g., metformin, insulin) 1.5. Induction of labor 1.6. Mode of delivery 1.7. Epidural analgesia for labor 1.8. Indication for cesarean delivery 1.9. Delivery blood loss 1.10. Shoulder dystocia 1.11. Third- or fourth-degree tear 1.12. Placenta weight 2. Neonatal outcomes assessed by reviewing patient’s and baby’s notes after delivery: 2.1. Birth weight (low birth weight 3.5 kg) 2.2. Umbilical cord arterial pH and base excess at birth 2.3. Apgar score at 1 and 5 minutes 2.4. Neonatal hypoglycemia 2.5. Neonatal birth injury (e.g., Erbs palsy, bone fracture, cephalhematoma etc) 2.6. Special care nursery/neonatal intensive care unit admission and indication

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026