Type 1 diabetes in pregnancy Pregnancy and Childbirth
Conditions
Sponsors
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care 2. The participant is between 18 and 45 years of age (inclusive) 3. A viable singleton pregnancy confirmed by ultrasound, at gestational age = 8 and = 24 weeks 4. The participant is on intensive insulin therapy (=3 injections or CSII) and compliant with diabetes self-management i.e. doing =4 SMBG tests per day 5. The participant is able and willing to use the study devices and complete the CGM and study pump run-in assessments 6. The participant is able to speak and understand English
Exclusion criteria
Exclusion criteria: 1. Non-type 1 diabetes mellitus 2. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results such as coeliac disease or untreated hypothyroidism. 3. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors. 4. Known or suspected allergy against insulin. 5. Women with nephropathy, neuropathy, gastroparesis or proliferative retinopathy as judged by the investigator that is likely to interfere with the normal conduct of the study and interpretation of study results. 6. Very good or very poor glycaemic control i.e. first antenatal HbA1c = 47mmol/mol (<6.5%) and current (within 2 weeks of recruitment) HbA1c =10% (86mmol/mol) 7. Total daily insulin dose ? 1.5 IU/kg at booking 8. Severe visual or hearing impairment 9. Unable to speak and understand English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time spent in the target glucose range from 3.5-7.8 mmol/L, as recorded by continuous glucose monitoring (CGM) during the 28 day intervention periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time with glucose levels in the hypoglycaemic range, based on continuous glucose monitoring (glucose levels 7.8 mmol/L) 3. Metabolic control assessed by change in HbA1c after the use of closed-loop system for 28 days, compared with that during continuous glucose monitoring without the closed-loop system for 28 days. HbA1c will be measured before and after each intervention arm 4. CGM data collected during intervention arms will be compared to baseline CGM readings 5. Trends in CGM data collected within intervention arms will also be evaluated on weekly basis (i.e. week 1 versus week 2 versus week 3 versus week 4) 6. CGM data collected after the intervention arms i.e. during pregnancy and up to 6 weeks post-partum will also be compared to baseline and intervention arm readings using CGM summary statistics and functional data analyses | — |
Countries
England, United Kingdom
Contacts
Public ContactZoe Stewart
Outcome results
None listed