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

Phase 2

Withdrawn

Conditions: Type 1 Diabetes

Interventions: Other: 5-day intervention with single-hormone closed-loop strategy
Other: 5-day intervention with sensor-augmented pump therapy
Device: Insulin pump
Device: Continuous glucose monitoring system
Drug: Insulin

Registration Number: NCT02488616

Lead Sponsor: Institut de Recherches Cliniques de Montreal

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: WITHDRAWN

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Males and females ≥ 18 years of old.
Clinical diagnosis of type 1 diabetes for at least one year.
The subject will have been on insulin pump therapy for at least 3 months.
HbA1c ≤ 10%.
Live in the area of Montreal.

Exclusion Criteria

Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
Pregnancy (ongoing or current attempt to become pregnant).
Severe hypoglycemic episode within two weeks of screening.
Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
Known or suspected allergy to the trial products
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sensor-augmented pump therapy	Continuous glucose monitoring system	Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
Single-hormone closed-loop strategy	5-day intervention with single-hormone closed-loop strategy	Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
Sensor-augmented pump therapy	5-day intervention with sensor-augmented pump therapy	Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
Sensor-augmented pump therapy	Insulin pump	Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
Single-hormone closed-loop strategy	Insulin pump	Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
Single-hormone closed-loop strategy	Continuous glucose monitoring system	Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
Sensor-augmented pump therapy	Insulin	Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
Single-hormone closed-loop strategy	Insulin	Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.

Primary Outcome Measures

Name	Time	Method
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L	120 hours

Secondary Outcome Measures

Name	Time	Method
Area under the curve of glucose levels below 3.9 mmol/L	120 hours
Area under the curve of glucose levels below 3.3 mmol/L	120 hours
Area under the curve of glucose levels below 2.8 mmol/L	120 hours
Percentage of time of overnight glucose levels spent below 3.3 mmol/L	35 hours
Percentage of time of overnight glucose levels spent below 2.8 mmol/L	35 hours
Percentage of time of overnight glucose levels spent above 10 mmol/L	35 hours
Percentage of time of overnight glucose levels spent above 13.9 mmol/L	35 hours
Percentage of time of overnight glucose levels spent above 16.7 mmol/L	35 hours
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L	120 hours
Percentage of time of glucose levels spent below 3.9 mmol/L	120 hours
Percentage of time of glucose levels spent below 3.3 mmol/L	120 hours
Percentage of time of glucose levels spent below 2.8 mmol/L	120 hours
Percentage of time of glucose levels spent above 10 mmol/L	120 hours
Percentage of time of glucose levels spent above 16.7 mmol/L	120 hours
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L	35 hours
Percentage of time of glucose levels spent above 13.9 mmol/L	120 hours
Percentage of time of overnight glucose levels spent below 3.9 mmol/L	35 hours
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L	35 hours
Area under the curve of glucose levels above 10 mmol/L	120 hours
Area under the curve of glucose levels above 13.9 mmol/L	120 hours
Area under the curve of glucose levels above 16.7 mmol/L	120 hours
Area under the curve of overnight glucose levels below 3.9 mmol/L	35 hours
Area under the curve of overnight glucose levels below 3.3 mmol/L	35 hours
Area under the curve of overnight glucose levels below 2.8 mmol/L	35 hours
Area under the curve of overnight glucose levels above 10 mmol/L	35 hours
Area under the curve of overnight glucose levels above 13.9 mmol/L	35 hours
Area under the curve of overnight glucose levels above 16.7 mmol/L	35 hours
Mean glucose levels	120 hours
Standard deviation of glucose levels	120 hours
Standard deviation of insulin delivery	120 hours
Coefficient of variance of glucose levels	120 hours
Coefficient of variance of insulin delivery	120 hours
Between-day variability in glucose levels	120 hours
Between-day variability in insulin delivery	120 hours
Total insulin delivery	120 hours
Percentage of time of closed-loop operation	120 hours
Percentage of time of glucose sensor availability	120 hours
Time between failures	120 hours	Total hours of closed-loop operation over number of failures
Number of hypoglycemic events less than 3.1 mmol/L	120 hours
Number of nights with hypoglycemic events less than 3.1 mmol/L	35 hours
Number of days with hypoglycemic events less than 3.1 mmol/L	120 hours

Trial Locations

Locations (1): Institut de recherches cliniques de Montréal
🇨🇦
Montreal, Quebec, Canada