Status:
COMPLETED
Closing the Loop in Adults With Type 1 Diabetes in the Home Setting
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Diabetes UK
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The main study objective is to compare real-time continuous subcutaneous glucose monitoring (CGM) combined with overnight automated closed-loop glucose control, and real-time CGM alone in the home set...
Detailed Description
Achievement of tight glycaemic control in type 1 diabetes mellitus (T1D) using intensive insulin regimens, which has been shown to be important for the prevention of long term diabetes-related complic...
Eligibility Criteria
Inclusion
- Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative.
- On insulin pump therapy for at least 3 months
Exclusion
- Non-type 1 diabetes mellitus
- Any physical/psychological disease likely to interfere with the study
- Taking medication likely to interfere with interpretation of the results
- Known/suspected allergy against insulin
- Patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Ongoing severe recurrent hypoglycaemia as judged by the investigator.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01440140
Start Date
December 1 2012
End Date
January 1 2014
Last Update
January 29 2014
Active Locations (3)
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1
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
2
King's College London
London, United Kingdom, SE5 9RJ
3
Northern General Hospital
Sheffield, United Kingdom, S5 7AU