Clinical trial NCT02488616: Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Closed-loop system
Artificial pancreas
Type 1 diabetes
Hypoglycemia
Insulin
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


Eligibility 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).

Primary outcomes:
measure: Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
timeFrame: 120 hours
Secondary outcomes:
measure: Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
timeFrame: 120 hours
measure: Percentage of time of glucose levels spent below 3.9 mmol/L
timeFrame: 120 hours
measure: Percentage of time of glucose levels spent below 3.3 mmol/L
timeFrame: 120 hours
measure: Percentage of time of glucose levels spent below 2.8 mmol/L
timeFrame: 120 hours
measure: Percentage of time of glucose levels spent above 10 mmol/L
timeFrame: 120 hours
measure: Percentage of time of glucose levels spent above 13.9 mmol/L
timeFrame: 120 hours
measure: Percentage of time of glucose levels spent above 16.7 mmol/L
timeFrame: 120 hours
measure: Percentage of time of overnight glucose levels spent below 3.9 mmol/L
timeFrame: 35 hours
measure: Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
timeFrame: 35 hours
measure: Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
timeFrame: 35 hours
measure: Percentage of time of overnight glucose levels spent below 3.3 mmol/L
timeFrame: 35 hours
measure: Percentage of time of overnight glucose levels spent below 2.8 mmol/L
timeFrame: 35 hours
measure: Percentage of time of overnight glucose levels spent above 10 mmol/L
timeFrame: 35 hours
measure: Percentage of time of overnight glucose levels spent above 13.9 mmol/L
timeFrame: 35 hours
measure: Percentage of time of overnight glucose levels spent above 16.7 mmol/L
timeFrame: 35 hours
measure: Area under the curve of glucose levels below 3.9 mmol/L
timeFrame: 120 hours
measure: Area under the curve of glucose levels below 3.3 mmol/L
timeFrame: 120 hours
measure: Area under the curve of glucose levels below 2.8 mmol/L
timeFrame: 120 hours
measure: Area under the curve of glucose levels above 10 mmol/L
timeFrame: 120 hours
measure: Area under the curve of glucose levels above 13.9 mmol/L
timeFrame: 120 hours
measure: Area under the curve of glucose levels above 16.7 mmol/L
timeFrame: 120 hours
measure: Area under the curve of overnight glucose levels below 3.9 mmol/L
timeFrame: 35 hours
measure: Area under the curve of overnight glucose levels below 3.3 mmol/L
timeFrame: 35 hours
measure: Area under the curve of overnight glucose levels below 2.8 mmol/L
timeFrame: 35 hours
measure: Area under the curve of overnight glucose levels above 10 mmol/L
timeFrame: 35 hours
measure: Area under the curve of overnight glucose levels above 13.9 mmol/L
timeFrame: 35 hours
measure: Area under the curve of overnight glucose levels above 16.7 mmol/L
timeFrame: 35 hours
measure: Mean glucose levels
timeFrame: 120 hours
measure: Standard deviation of glucose levels
timeFrame: 120 hours
measure: Standard deviation of insulin delivery
timeFrame: 120 hours
measure: Coefficient of variance of glucose levels
timeFrame: 120 hours
measure: Coefficient of variance of insulin delivery
timeFrame: 120 hours
measure: Between-day variability in glucose levels
timeFrame: 120 hours
measure: Between-day variability in insulin delivery
timeFrame: 120 hours
measure: Total insulin delivery
timeFrame: 120 hours
measure: Percentage of time of closed-loop operation
timeFrame: 120 hours
measure: Percentage of time of glucose sensor availability
timeFrame: 120 hours
measure: Time between failures
timeFrame: 120 hours
measure: Number of hypoglycemic events less than 3.1 mmol/L
timeFrame: 120 hours
measure: Number of nights with hypoglycemic events less than 3.1 mmol/L
timeFrame: 35 hours
measure: Number of days with hypoglycemic events less than 3.1 mmol/L
timeFrame: 120 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Rémi Rabasa-Lhoret, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: