Early-onset type 2 diabetes in pregnancy Pregnancy and Childbirth
Conditions
Interventions
Recruitment visit: When women have expressed their wish to participate, they will be invited for the recruitment visit, when the following activities will be performed by the research team:
• Checking
Sponsors
University of East Anglia
Eligibility
Sex/Gender
Female
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 12/03/2026: 1. Type 2 diabetes (T2D) 2. 16 years of age or over 3. Confirmed pregnancy 4. HbA1c of > = 43 mmol/mol (6.1%) in pregnancy (prior to randomisation) 5. Willingness to use the study devices throughout the trial 6. Able to provide informed consent 7. 4 days (aiming for =96 hours) of baseline CGM data before randomisation at no later than 16+0 weeks’ gestation. In cases where 72-96 hours of CGM data is available, inclusion may be approved by the NCTU team _____ Previous key inclusion criteria: 1. Type 2 diabetes (T2D) 2. 16 years of age or over 3. Confirmed pregnancy =43 mmol/mol (6.1%) in pregnancy (<=14 weeks’ gestation) 5. Willingness to use the study devices throughout the trial 6. Able to provide informed consent
Exclusion criteria
Exclusion criteria: Current key exclusion criteria of of 12/03/2026: 1. Non-type 2 diabetes 2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min) _____ Previous key exclusion criteria: 1. Non-type 2 diabetes 2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min) 3. Severe visual impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage time spent with maternal glucose levels within target range as recorded by CGM Time-In-Range (TIR 3.5-7.8mmol/l) from 20 until 38 weeks’ gestation or until delivery, if delivery is earlier than 38 weeks’ gestation 2. Neonatal unit admission or death (stillbirth/neonatal death) From randomisation to discharge after delivery (or 28 days post delivery if admission prolonged) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HbA1c & CGM mean glucose, GMI, frequency & duration of glycaemic excursions [%Time-Above-Range (=6.7 & =7.8mmol/L), %Time-Below-Range (=3.5 & =3.0mmol/l)], glycaemic variability (glucose SD, CV)] From 20 until 38 weeks’ gestation or until delivery, if delivery is earlier than 38 weeks’ gestation 2. Hypertensive disorders from randomisation to discharge after delivery (or 28 days post delivery if admission prolonged) 3. Gestational weight gain from baseline (early pregnancy) to last visit prior to delivery 4. Diabetes treatment (metformin & insulin use) From 20 until 38 weeks’ gestation or until delivery, if delivery is earlier than 38 weeks’ gestation 5. Hospital admissions & duration of stay from randomisation to discharge after delivery (or 28 days post delivery if admission prolonged) 6. Severe hypoglycaemia, hyperosmolar hyperglycaemic state, and diabetic ketoacidosis episodes from randomisation to discharge after delivery (or 28 days post delivery if admission prolonged) 7. Gestational age at birth 8. Birth weight for gestational age (SDS) (GROW customised birth weight, LGA birth weight >90th centile or SGA 24hrs (duration of stay, highest level care) at Discharge after delivery 11. Adverse events (pregnancy loss <24 weeks, congenital anomaly (any), stillbirth, neonatal death) at Delivery 12. Birth injury (spinal cord injury, clavicular, skull or bone fracture, shoulder dystocia, nerve palsy, subdural or intracerebral haemorrhage, hypoxic ischaemic encephalopathy) at Birth 13. Neonatal morbidity (treatment for neonatal hypoglycaemia, respiratory distress requiring treatment, neonatal jaundice requiring treatment) at Discharge after delivery 14. Feeding at hospital discharge (exclusive breast-feeding / partial breast-feeding / exclusive formula feeding) at Discharge after delivery 15. Diabetes distress, anxiety & depression and treatment satisfaction using short questionnaires at Baseline & 32 weeks’ gestation 16. Qualitative study to explore the acceptabilit | — |
Countries
England, United Kingdom
Contacts
Public ContactCorinne;Study Collett;Team
;
Outcome results
None listed