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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02488616
• Date of registration: 26/06/2015
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Cliniques de Montreal
• Public title: Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes
• Scientific title: An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 5 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes
• Date of first enrolment: March 2018
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02488616
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Rémi Rabasa-Lhoret, MD, PhD
• Affiliation: Institut de recherches cliniques de Montréal

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Device: Insulin pump

Other: 5-day intervention with single-hormone closed-loop strategy

Other: 5-day intervention with sensor-augmented pump therapy

Device: Continuous glucose monitoring system

Drug: Insulin

Primary Outcome(s)

Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L [Time Frame: 120 hours]

Secondary Outcome(s)

Area under the curve of glucose levels above 13.9 mmol/L [Time Frame: 120 hours]

Area under the curve of overnight glucose levels above 10 mmol/L [Time Frame: 35 hours]

Area under the curve of overnight glucose levels above 16.7 mmol/L [Time Frame: 35 hours]

Percentage of time of glucose levels spent below 3.3 mmol/L [Time Frame: 120 hours]

Percentage of time of overnight glucose levels spent above 10 mmol/L [Time Frame: 35 hours]

Percentage of time of overnight glucose levels spent above 16.7 mmol/L [Time Frame: 35 hours]

Percentage of time of overnight glucose levels spent below 3.3 mmol/L [Time Frame: 35 hours]

Standard deviation of insulin delivery [Time Frame: 120 hours]

Coefficient of variance of insulin delivery [Time Frame: 120 hours]

Number of days with hypoglycemic events less than 3.1 mmol/L [Time Frame: 120 hours]

Area under the curve of overnight glucose levels below 3.3 mmol/L [Time Frame: 35 hours]

Area under the curve of overnight glucose levels below 3.9 mmol/L [Time Frame: 35 hours]

Percentage of time of overnight glucose levels spent above 13.9 mmol/L [Time Frame: 35 hours]

Percentage of time of overnight glucose levels spent below 3.9 mmol/L [Time Frame: 35 hours]

Time between failures [Time Frame: 120 hours]

Area under the curve of glucose levels below 3.3 mmol/L [Time Frame: 120 hours]

Number of hypoglycemic events less than 3.1 mmol/L [Time Frame: 120 hours]

Percentage of time of glucose levels spent above 16.7 mmol/L [Time Frame: 120 hours]

Total insulin delivery [Time Frame: 120 hours]

Area under the curve of glucose levels above 16.7 mmol/L [Time Frame: 120 hours]

Area under the curve of overnight glucose levels above 13.9 mmol/L [Time Frame: 35 hours]

Area under the curve of overnight glucose levels below 2.8 mmol/L [Time Frame: 35 hours]

Between-day variability in insulin delivery [Time Frame: 120 hours]

Percentage of time of closed-loop operation [Time Frame: 120 hours]

Percentage of time of overnight glucose levels spent below 2.8 mmol/L [Time Frame: 35 hours]

Percentage of time of glucose levels spent below 3.9 mmol/L [Time Frame: 120 hours]

Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L [Time Frame: 35 hours]

Area under the curve of glucose levels below 2.8 mmol/L [Time Frame: 120 hours]

Coefficient of variance of glucose levels [Time Frame: 120 hours]

Mean glucose levels [Time Frame: 120 hours]

Percentage of time of glucose levels spent above 10 mmol/L [Time Frame: 120 hours]

Percentage of time of glucose levels spent above 13.9 mmol/L [Time Frame: 120 hours]

Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L [Time Frame: 120 hours]

Area under the curve of glucose levels above 10 mmol/L [Time Frame: 120 hours]

Area under the curve of glucose levels below 3.9 mmol/L [Time Frame: 120 hours]

Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L [Time Frame: 35 hours]

Between-day variability in glucose levels [Time Frame: 120 hours]

Number of nights with hypoglycemic events less than 3.1 mmol/L [Time Frame: 35 hours]

Percentage of time of glucose levels spent below 2.8 mmol/L [Time Frame: 120 hours]

Standard deviation of glucose levels [Time Frame: 120 hours]

Percentage of time of glucose sensor availability [Time Frame: 120 hours]

Secondary ID(s)

CLASS-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors