Clinical trial NCT02846831: Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 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 12 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Artificial pancreas
Closed-loop system
Hypoglycemia
Insulin
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 36
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 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.


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 ≤ 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)

Primary outcomes:
measure: Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.
timeFrame: 288 hours
Secondary outcomes:
measure: Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
timeFrame: 288 hours
measure: Percentage of time of glucose levels spent below 3.9 mmol/L
timeFrame: 288 hours
measure: Percentage of time of glucose levels spent below 3.3 mmol/L
timeFrame: 288 hours
measure: Percentage of time of glucose levels spent below 2.8 mmol/L
timeFrame: 288 hours
measure: Percentage of time of glucose levels spent above 10.0 mmol/L
timeFrame: 288 hours
measure: Percentage of time of glucose levels spent above 13.9 mmol/L
timeFrame: 288 hours
measure: Percentage of time of glucose levels spent above 16.7 mmol/L
timeFrame: 288 hours
measure: Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
timeFrame: 72 hours
measure: Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
timeFrame: 72 hours
measure: Percentage of time of overnight glucose levels spent below 3.9 mmol/L
timeFrame: 72 hours
measure: Percentage of time of overnight glucose levels spent below 3.3 mmol/L
timeFrame: 72 hours
measure: Percentage of time of overnight glucose levels spent below 2.8 mmol/L
timeFrame: 72 hours
measure: Percentage of time of overnight glucose levels spent above 10.0 mmol/L
timeFrame: 72 hours
measure: Percentage of time of overnight glucose levels spent above 13.9 mmol/L
timeFrame: 72 hours
measure: Percentage of time of overnight glucose levels spent above 16.7 mmol/L
timeFrame: 72 hours
measure: Total number of hypoglycemic events below 3.1 mmol/L
timeFrame: 288 hours
measure: Number of nights with hypoglycemic events below 3.1 mmol/L
timeFrame: 72 hours
measure: Number of days with hypoglycemic events below 3.1 mmol/L
timeFrame: 126 hours
measure: Mean glucose levels
timeFrame: 288 hours
measure: Standard deviation of glucose levels
timeFrame: 288 hours
measure: Time between failures due to glucose sensor unavailability
timeFrame: 288 hours
measure: Coefficient of variation of glucose levels
timeFrame: 288 hours
measure: Between-day variability in glucose levels
timeFrame: 288 hours
measure: Total daily insulin dose
timeFrame: 24 hours
measure: Standard deviation of insulin delivery
timeFrame: 288 hours
measure: Coefficient of variation of insulin delivery
timeFrame: 288 hours
measure: Between-day variability in insulin delivery
timeFrame: 288 hours
measure: Total number of hours of glucose sensor availability
timeFrame: 288 hours
measure: Percentage of time of glucose sensor availability
timeFrame: 288 hours
measure: Time between failures due to pump connectivity
timeFrame: 288 hours
measure: Percentage of time when patients switched back to insulin pump therapy
timeFrame: 288 hours
measure: Number of hours when patients switched back to insulin pump therapy
timeFrame: 288 hours
measure: Percentage of time when the closed-loop was automatically switched to insulin pump therapy
timeFrame: 288 hours
measure: Number of hours when the closed-loop was automatically switched to insulin pump therapy
timeFrame: 288 hours
measure: Number of days with at least one technical problem
timeFrame: 288 hours
measure: Number of calls for technical issues related to the closed-loop system
timeFrame: 288 hours
measure: Number of patients calling for technical issues related to the closed-loop system
timeFrame: 288 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Rémi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haidar A, Legault L, Raffray M, Gouchie-Provencher N, Jacobs PG, El-Fathi A, Rutkowski J, Messier V, Rabasa-Lhoret R. Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial. Diabetes Technol Ther. 2021 Mar;23(3):168-174. doi: 10.1089/dia.2020.0365. Epub 2020 Dec 31.