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

Phase 2

Completed

Conditions: Type 1 Diabetes

Interventions: Other: 12-day intervention with sensor-augmented pump therapy
Other: 12-day intervention with single-hormone closed-loop strategy
Device: Insulin pump
Device: Continuous glucose monitoring system
Drug: Insulin

Registration Number: NCT02846831

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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 ≤ 12%.

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)
Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
Pregnancy (ongoing or current attempt to become pregnant)
Breastfeeding
No nearby party for assistance if needed
Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period
Severe hypoglycemic episode within two weeks of screening or during the run-in period
Severe hyperglycemic episode requiring hospitalization in the last 3 months
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
Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
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.
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.
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	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.
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.
Sensor-augmented pump therapy	12-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.
Single-hormone closed-loop strategy	12-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.

Primary Outcome Measures

Name	Time	Method
Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.	288 hours

Secondary Outcome Measures

Name	Time	Method
Percentage of time of overnight glucose levels spent above 10.0 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent above 13.9 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent above 16.7 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Total number of hypoglycemic events below 3.1 mmol/L	288 hours
Number of nights with hypoglycemic events below 3.1 mmol/L	72 hours
Mean glucose levels	288 hours
Standard deviation of glucose levels	288 hours
Time between failures due to glucose sensor unavailability	288 hours
Coefficient of variation of glucose levels	288 hours
Between-day variability in glucose levels	288 hours
Total daily insulin dose	24 hours
Standard deviation of insulin delivery	288 hours
Coefficient of variation of insulin delivery	288 hours
Between-day variability in insulin delivery	288 hours
Total number of hours of glucose sensor availability	288 hours
Number of hours when patients switched back to insulin pump therapy	288 hours
Percentage of time when the closed-loop was automatically switched to insulin pump therapy	288 hours
Number of hours when the closed-loop was automatically switched to insulin pump therapy	288 hours
Number of days with at least one technical problem	288 hours
Number of calls for technical issues related to the closed-loop system	288 hours
Number of patients calling for technical issues related to the closed-loop system	288 hours
Percentage of time of glucose sensor availability	288 hours
Time between failures due to pump connectivity	288 hours
Percentage of time of overnight glucose levels spent below 2.8 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L	288 hours
Percentage of time of glucose levels spent below 3.9 mmol/L	288 hours
Percentage of time of glucose levels spent below 3.3 mmol/L	288 hours
Percentage of time of glucose levels spent below 2.8 mmol/L	288 hours
Percentage of time of glucose levels spent above 10.0 mmol/L	288 hours
Percentage of time of glucose levels spent above 13.9 mmol/L	288 hours
Percentage of time of glucose levels spent above 16.7 mmol/L	288 hours
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent below 3.9 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent below 3.3 mmol/L	72 hours	The overnight period is between 00:00 and 06:00
Number of days with hypoglycemic events below 3.1 mmol/L	126 hours
Percentage of time when patients switched back to insulin pump therapy	288 hours

Trial Locations

Locations (2): Institut de recherches cliniques de Montréal
🇨🇦
Montreal, Quebec, Canada
McGill University Health Centre
🇨🇦
Montreal, Quebec, Canada
Institut de recherches cliniques de Montréal
🇨🇦Montreal, Quebec, Canada