Status:
WITHDRAWN
Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Conditions:
Type 1 Diabetes Mellitus
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...
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 6 months.
- HbA1c ≤ 12%.
Exclusion
- Using a patch-pump (e.g. Omnipod)
- 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.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- 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 meals/snacks, not willing to change pump parameters, etc).
- Problems with venous access.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03335501
Start Date
April 1 2018
End Date
December 31 2018
Last Update
April 27 2018
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