Status:
COMPLETED
Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ 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 and females ≥ 18 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 ≤ 12%.
- Hypoglycemia awareness or unawareness assessed by a questionnaire.
- Documented NH during the run-in period.
Exclusion
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose).
- Known or suspected allergy to the trial products or snack contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
- Failure to comply with team's recommendations (e.g. not willing to eat snacks, not willing to change pump parameters, etc).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02282254
Start Date
October 1 2014
End Date
July 1 2016
Last Update
November 10 2016
Active Locations (1)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7