Continuous glucose monitoring amongst pregnant women with early-onset type 2 diabetes

Not Applicable

• Conditions: Early-onset type 2 diabetes in pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN12804317
• Lead Sponsor: niversity of East Anglia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-23
• Last Update Posted: 13 November 2023
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 422

Inclusion Criteria

1. Type 2 diabetes (T2D)
2. 16 years of age or over
3. Confirmed pregnancy < = 14 weeks’ gestation
4. HbA1c of > = 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

1. Non-type 2 diabetes
2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min)
3. Severe visual impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Neonatal unit admission or death (stillbirth/neonatal death) From randomisation to discharge after delivery (or 28 days post delivery if admission prolonged)