Closed-loop in pregnancy day and night home feasibility study (CLIP 24/7)

Completed

• Conditions: Type 1 diabetes in pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN83316328
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29535135

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-08
• Study Completion: 2016-12-31
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified