Back to resultsClosed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
60-minute exercise
Insulin pump
Dexcom G4 Platinum glucose sensor
Insulin
Single-hormone closed-loop strategy
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Closed-loop system, Artificial pancreas, Exercise, Hypoglycemia, Insulin, Type 1 diabetes
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.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- Problems with venous access.
Sites / Locations
- Institut de recherches cliniques de Montréal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Unannounced exercise
Announced exercise with pre-meal full bolus
Announced exercise with reduced insulin bolus
Arm Description
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
Outcomes
Primary Outcome Measures
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Secondary Outcome Measures
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Decremental area under the curve from the start of the exercise
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Percentage of time of plasma glucose levels spent above 10 mmol/L
Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Mean plasma glucose levels
Standard deviation of glucose levels
Coefficient of variation of glucose levels
Mean time (minutes) to the first hypoglycemic event
Full Information
NCT ID
NCT02855307
First Posted
August 1, 2016
Last Updated
February 8, 2019
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT02855307
Brief Title
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
Official Title
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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 artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Closed-loop system, Artificial pancreas, Exercise, Hypoglycemia, Insulin, Type 1 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unannounced exercise
Arm Type
Active Comparator
Arm Description
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
Arm Title
Announced exercise with pre-meal full bolus
Arm Type
Active Comparator
Arm Description
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
Arm Title
Announced exercise with reduced insulin bolus
Arm Type
Active Comparator
Arm Description
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
Intervention Type
Other
Intervention Name(s)
60-minute exercise
Intervention Description
Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.
Intervention Type
Device
Intervention Name(s)
Insulin pump
Intervention Description
Patient's insulin pump will be used to infuse insulin.
Intervention Type
Device
Intervention Name(s)
Dexcom G4 Platinum glucose sensor
Intervention Description
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Patient's usual fast-acting insulin analog will be used.
Intervention Type
Other
Intervention Name(s)
Single-hormone closed-loop strategy
Intervention Description
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
Primary Outcome Measure Information:
Title
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Time Frame
From 9:30 to 11:30 (120 minutes)
Secondary Outcome Measure Information:
Title
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Description
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
Time Frame
From 8:00 to 10:50 (170 minutes)
Title
Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Decremental area under the curve from the start of the exercise
Time Frame
From 9:30 to 11:00 (90 minutes)
Title
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Percentage of time of plasma glucose levels spent above 10 mmol/L
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Time Frame
From 9:30 to 10:30 (60 minutes)
Title
Mean plasma glucose levels
Time Frame
From 8:00 to 11:30 (210 minutes)
Title
Standard deviation of glucose levels
Time Frame
From 8:00 to 11:30 (210 minutes)
Title
Coefficient of variation of glucose levels
Time Frame
From 8:00 to 11:30 (210 minutes)
Title
Mean time (minutes) to the first hypoglycemic event
Time Frame
From 9:30 to 10:30 (60 minutes)
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.
Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
Use of medication with an effect on heart rate (e.g. beta-blockers).
Abnormal blood panel and/or anemia.
Ongoing or planned pregnancy.
Severe hypoglycemic episode within two weeks of screening.
Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
Problems with venous access.
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32740723
Citation
Tagougui S, Taleb N, Legault L, Suppere C, Messier V, Boukabous I, Shohoudi A, Ladouceur M, Rabasa-Lhoret R. A single-blind, randomised, crossover study to reduce hypoglycaemia risk during postprandial exercise with closed-loop insulin delivery in adults with type 1 diabetes: announced (with or without bolus reduction) vs unannounced exercise strategies. Diabetologia. 2020 Nov;63(11):2282-2291. doi: 10.1007/s00125-020-05244-y. Epub 2020 Aug 1.
Results Reference
derived
Learn more about this trial
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
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