Status:
COMPLETED
Closing the Loop 24/7 in Adolescents With Type 1 Diabetes
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong insulin therapy. Children and adolescents with T1D need regular insulin injections or the continuous insul...
Detailed Description
The main objective of this study is to determine the efficacy, safety and utility of automated closed-loop glucose control in the home setting over a short term period, including the daytime and durin...
Eligibility Criteria
Inclusion
- The subject is between 10 and 18 years of age (inclusive)
- The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- The subject/carer will have been an insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
- The subject/carer is willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements taken every day
- HbA1c between 7.0% and 11.0 % (53 to 97mmol/mol) based on analysis from central laboratory or equivalent
- The subject is literate in English
- The subject is willing to wear closed-loop system at home and at school / college / work
- The subject is willing to follow study specific instructions
Exclusion
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- Known or suspected allergy against insulin
- Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- Significantly reduced hypoglycaemia awareness as judged by the investigator
- Total daily insulin dose ≥ 2 IU/kg/day
- Total daily insulin dose \<10 IU/day
- Reduced hypoglycaemia awareness
- Pregnancy, planned pregnancy or breast feeding
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pacemaker
- Lack of reliable telephone facility for contact
Key Trial Info
Start Date :
August 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01873066
Start Date
August 28 2014
End Date
January 1 2016
Last Update
March 3 2017
Active Locations (1)
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1
University of Cambridge
Cambridge, United Kingdom, CB2 0QQ