Status:
COMPLETED
Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
McGill University
Montreal Children's Hospital of the MUHC
Conditions:
Type-1 Diabetes
Eligibility:
All Genders
18-65 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...
Eligibility Criteria
Inclusion
- Males and females ≥ 18 and ≤ 65 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); C peptide level and antibody determinations are not needed.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion
- Clinically significant nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator.
- Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- • Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin
- Known or suspected allergy to the trial products or meal 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.
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- Unreliable carbohydrate counting
- Problems with venous access
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
End Date :
November 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01519102
Start Date
January 1 2012
End Date
November 1 2012
Last Update
December 10 2012
Active Locations (1)
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1
Institut de Recherches Cliniques de Montréal (IRCM)
Montreal, Quebec, Canada, H2W 1R7