Status:
COMPLETED
Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
Montreal Children's Hospital of the MUHC
Mount Sinai Hospital, New York
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12+ 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 aged ≥ 12 years of old.
- Body mass index \< 35
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 4 months.
- HbA1c \< 12%.
- At least two visits with an endocrinology team in the past 1 year.
Exclusion
- Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
- Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
- Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
- 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 treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
- Failure to comply with team's recommendations.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01905020
Start Date
July 1 2013
End Date
September 1 2014
Last Update
October 21 2014
Active Locations (3)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada
2
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
3
Montreal Children Hospital
Montreal, Quebec, Canada