Overview

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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 dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates glucose levels through the infusion of two hormones: insulin and glucagon. The objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults. The investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Treatments:
Glucagon
Glucagon-Like Peptide 1
Hormones
Insulin
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

1. Males and females ≥ 12 years of old.

2. Clinical diagnosis of type 1 diabetes for at least one year.

3. The subject will have been on insulin pump therapy for at least 3 months.

4. HbA1c ≤ 11%.

Exclusion Criteria:

1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the
investigator.

2. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac
surgery.

3. History of pheochromocytoma or insulinoma (glucagon could induce a hormonal response
of these tumors)

4. Beta-blockers at high dose based on investigator's evaluation of dosage interference
with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very
high doses)

5. Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability
to raise glucose)

6. Chronic acetaminophen treatment (can interfere with glucose sensor measurements)

7. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the
risk of bleeding)

8. Anticholinergic drug (risk of interaction)

9. Pregnancy.

10. Severe hypoglycemic episode within two weeks of screening.

11. Current use of glucocorticoid medication (except low stable dose and inhaled
steroids).

12. Known or suspected allergy to the trial products

13. Other serious medical illness likely to interfere with study participation or with the
ability to complete the trial by the judgment of the investigator.

14. Anticipating a significant change in exercise regimen between admissions (i.e.
starting or stopping an organized sport).

15. Treatments that could interfere with glucagon