Status:
COMPLETED
Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
Montreal Children's Hospital of the MUHC
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
Brief Summary
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosage...
Detailed Description
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosage...
Eligibility Criteria
Inclusion
- Males or females between the 8 and 17 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months.
- HbA1c ≤ 11.0%.
Exclusion
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.
- Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
- Known or suspected allergy to the trial products.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02189694
Start Date
June 1 2014
End Date
August 1 2014
Last Update
September 3 2014
Active Locations (1)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7