Back to resultsClosed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
12-day intervention with sensor-augmented pump therapy
12-day intervention with single-hormone closed-loop strategy
Insulin pump
Continuous glucose monitoring system
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Artificial pancreas, Closed-loop system, Hypoglycemia, Insulin
Eligibility Criteria
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)
Sites / Locations
- Institut de recherches cliniques de Montréal
- McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sensor-augmented pump therapy
Single-hormone closed-loop strategy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.
Secondary Outcome Measures
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Percentage of time of glucose levels spent below 3.9 mmol/L
Percentage of time of glucose levels spent below 3.3 mmol/L
Percentage of time of glucose levels spent below 2.8 mmol/L
Percentage of time of glucose levels spent above 10.0 mmol/L
Percentage of time of glucose levels spent above 13.9 mmol/L
Percentage of time of glucose levels spent above 16.7 mmol/L
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
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
The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent below 3.9 mmol/L
The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent below 3.3 mmol/L
The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent below 2.8 mmol/L
The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent above 10.0 mmol/L
The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent above 13.9 mmol/L
The overnight period is between 00:00 and 06:00
Percentage of time of overnight glucose levels spent above 16.7 mmol/L
The overnight period is between 00:00 and 06:00
Total number of hypoglycemic events below 3.1 mmol/L
Number of nights with hypoglycemic events below 3.1 mmol/L
Number of days with hypoglycemic events below 3.1 mmol/L
Mean glucose levels
Standard deviation of glucose levels
Time between failures due to glucose sensor unavailability
Coefficient of variation of glucose levels
Between-day variability in glucose levels
Total daily insulin dose
Standard deviation of insulin delivery
Coefficient of variation of insulin delivery
Between-day variability in insulin delivery
Total number of hours of glucose sensor availability
Percentage of time of glucose sensor availability
Time between failures due to pump connectivity
Percentage of time when patients switched back to insulin pump therapy
Number of hours when patients switched back to insulin pump therapy
Percentage of time when the closed-loop was automatically switched to insulin pump therapy
Number of hours when the closed-loop was automatically switched to insulin pump therapy
Number of days with at least one technical problem
Number of calls for technical issues related to the closed-loop system
Number of patients calling for technical issues related to the closed-loop system
Full Information
NCT ID
NCT02846831
First Posted
July 25, 2016
Last Updated
June 8, 2020
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT02846831
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
January 27, 2020 (Actual)
Study Completion Date
January 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Artificial pancreas, Closed-loop system, Hypoglycemia, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensor-augmented pump therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Single-hormone closed-loop strategy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
12-day intervention with sensor-augmented pump therapy
Intervention Description
A sensor will be inserted on the day before the start of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 12 days.
Participants will have been previously shown how to use the study insulin pump.
Intervention Type
Other
Intervention Name(s)
12-day intervention with single-hormone closed-loop strategy
Intervention Description
A sensor will be inserted on the day before the start of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given.
Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 12 days.
Intervention Type
Device
Intervention Name(s)
Insulin pump
Intervention Description
Tandem Diabetes Care
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring system
Intervention Description
Dexcom G5 Platinum
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
Primary Outcome Measure Information:
Title
Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.
Time Frame
288 hours
Secondary Outcome Measure Information:
Title
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time Frame
288 hours
Title
Percentage of time of glucose levels spent below 3.9 mmol/L
Time Frame
288 hours
Title
Percentage of time of glucose levels spent below 3.3 mmol/L
Time Frame
288 hours
Title
Percentage of time of glucose levels spent below 2.8 mmol/L
Time Frame
288 hours
Title
Percentage of time of glucose levels spent above 10.0 mmol/L
Time Frame
288 hours
Title
Percentage of time of glucose levels spent above 13.9 mmol/L
Time Frame
288 hours
Title
Percentage of time of glucose levels spent above 16.7 mmol/L
Time Frame
288 hours
Title
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Percentage of time of overnight glucose levels spent below 3.9 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Percentage of time of overnight glucose levels spent below 3.3 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Percentage of time of overnight glucose levels spent below 2.8 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Percentage of time of overnight glucose levels spent above 10.0 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Percentage of time of overnight glucose levels spent above 13.9 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Percentage of time of overnight glucose levels spent above 16.7 mmol/L
Description
The overnight period is between 00:00 and 06:00
Time Frame
72 hours
Title
Total number of hypoglycemic events below 3.1 mmol/L
Time Frame
288 hours
Title
Number of nights with hypoglycemic events below 3.1 mmol/L
Time Frame
72 hours
Title
Number of days with hypoglycemic events below 3.1 mmol/L
Time Frame
126 hours
Title
Mean glucose levels
Time Frame
288 hours
Title
Standard deviation of glucose levels
Time Frame
288 hours
Title
Time between failures due to glucose sensor unavailability
Time Frame
288 hours
Title
Coefficient of variation of glucose levels
Time Frame
288 hours
Title
Between-day variability in glucose levels
Time Frame
288 hours
Title
Total daily insulin dose
Time Frame
24 hours
Title
Standard deviation of insulin delivery
Time Frame
288 hours
Title
Coefficient of variation of insulin delivery
Time Frame
288 hours
Title
Between-day variability in insulin delivery
Time Frame
288 hours
Title
Total number of hours of glucose sensor availability
Time Frame
288 hours
Title
Percentage of time of glucose sensor availability
Time Frame
288 hours
Title
Time between failures due to pump connectivity
Time Frame
288 hours
Title
Percentage of time when patients switched back to insulin pump therapy
Time Frame
288 hours
Title
Number of hours when patients switched back to insulin pump therapy
Time Frame
288 hours
Title
Percentage of time when the closed-loop was automatically switched to insulin pump therapy
Time Frame
288 hours
Title
Number of hours when the closed-loop was automatically switched to insulin pump therapy
Time Frame
288 hours
Title
Number of days with at least one technical problem
Time Frame
288 hours
Title
Number of calls for technical issues related to the closed-loop system
Time Frame
288 hours
Title
Number of patients calling for technical issues related to the closed-loop system
Time Frame
288 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret
Organizational Affiliation
Institut de recherches cliniques de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33050728
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.
Results Reference
derived
Learn more about this trial
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes
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