Status:
COMPLETED
Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
Children and adolescents with type 1 diabetes need regular insulin injections or continuous insulin delivery with an insulin pump in order to keep blood sugar levels normal. The investigators know tha...
Eligibility Criteria
Inclusion
- Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care.
- The subject is between 6 and 18 years of age (inclusive).
- The subject has type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative.
- The subject will have been on insulin pump for at least 3 months
Exclusion
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
- Taking medication likely to interfere with interpretation of the results
- Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator).
- Known or suspected allergy against insulin.
- Patients with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00989898
Start Date
February 1 2009
End Date
December 1 2011
Last Update
June 25 2012
Active Locations (1)
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1
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB20QQ