ISRCTN83316328
Completed
Not Applicable
Evaluation of the feasibility, utility, safety and efficacy of day and night closed-loop insulin delivery at home in women with type 1 diabetes during pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 diabetes in pregnancy
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29535135
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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