Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

• Status: Withdrawn
• Trial end date: 2018-11-01
• 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.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes.

The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.

• 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 ≥ 18 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 ≤ 10%.

5. Live in the area of Montreal.

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

4. Pregnancy (ongoing or current attempt to become pregnant).

5. Severe hypoglycemic episode within two weeks of screening.

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

7. Known or suspected allergy to the trial products

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

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