Status:
COMPLETED
Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The main objective is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults wi...
Detailed Description
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term c...
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 results
- Known/suspected allergy against insulin
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
- Current pregnancy/breastfeeding
- Total daily insulin dose \> 1.4 IU/kg
- HbA1C \> 10% within the last 3 months
- Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00944619
Start Date
September 1 2009
End Date
December 1 2009
Last Update
May 12 2010
Active Locations (1)
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1
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ