Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes

• Status: Completed
• Trial end date: 2020-01-27
• 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 objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings.

The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than 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 ≤ 12%.

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. Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings

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

6. Breastfeeding

7. No nearby party for assistance if needed

8. Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period

9. Severe hypoglycemic episode within two weeks of screening or during the run-in period

10. Severe hyperglycemic episode requiring hospitalization in the last 3 months

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. Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)