Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
Primary Purpose
Type 1 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Insulin pump
Continuous glucose monitoring system
11-hour intervention with the single-hormone artificial pancreas
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Closed-loop control, Artificial pancreas, Postprandial glucose control, 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 6 months.
- HbA1c ≤ 12%.
Exclusion Criteria:
- Using a patch-pump (e.g. Omnipod)
- 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.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- Known or suspected allergy to the trial products or meal contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
- Problems with venous access.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rapid-acting Aspart
Faster insulin Aspart
Arm Description
Rapid-acting Aspart will be used to regulate glucose levels
Faster insulin Aspart will be used to regulate glucose levels
Outcomes
Primary Outcome Measures
Change in plasma glucose levels 1 hour after the meal
Secondary Outcome Measures
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Plasma glucose level 1 hour after the meal.
Plasma glucose level 2 hours after the meal.
Glycemic peak in the 3 hours following the meal.
Change in plasma glucose levels 2 hours after the meal.
Peak time of glucose levels over the 4 hours following the meal.
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Percentage of time of plasma glucose levels above 10 mmol/L.
Percentage of time of sensor glucose levels above 10 mmol/L.
Percentage of time of plasma glucose levels above 13.9 mmol/L
Percentage of time of sensor glucose levels above 13.9 mmol/L
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Standard deviation of plasma glucose levels.
Standard deviation of sensor glucose levels.
Coefficient of variance of plasma glucose levels.
Coefficient of variance of sensor glucose levels.
Total insulin delivery.
Mean plasma glucose level.
Mean sensor glucose level.
Mean plasma insulin concentration.
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Full Information
NCT ID
NCT03335501
First Posted
November 3, 2017
Last Updated
April 25, 2018
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT03335501
Brief Title
Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
Official Title
An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The owner of the algorithm does not wish that this study be undertaken
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
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
No
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 pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Closed-loop control, Artificial pancreas, Postprandial glucose control, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid-acting Aspart
Arm Type
Active Comparator
Arm Description
Rapid-acting Aspart will be used to regulate glucose levels
Arm Title
Faster insulin Aspart
Arm Type
Active Comparator
Arm Description
Faster insulin Aspart will be used to regulate glucose levels
Intervention Type
Device
Intervention Name(s)
Insulin pump
Intervention Description
The participant's insulin pump will be used to infuse insulin
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring system
Intervention Description
The Dexcom G4 Platinum will be used to measure glucose levels
Intervention Type
Other
Intervention Name(s)
11-hour intervention with the single-hormone artificial pancreas
Intervention Description
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.
At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.
Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.
Primary Outcome Measure Information:
Title
Change in plasma glucose levels 1 hour after the meal
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Time Frame
1 hour
Title
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Time Frame
2 hours
Title
Plasma glucose level 1 hour after the meal.
Time Frame
1 hour
Title
Plasma glucose level 2 hours after the meal.
Time Frame
2 hours
Title
Glycemic peak in the 3 hours following the meal.
Time Frame
3 hours
Title
Change in plasma glucose levels 2 hours after the meal.
Time Frame
2 hours
Title
Peak time of glucose levels over the 4 hours following the meal.
Time Frame
4 hours
Title
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Time Frame
4 hours
Title
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Time Frame
11 hours
Title
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Time Frame
11 hours
Title
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Time Frame
11 hours
Title
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Time Frame
11 hours
Title
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Time Frame
11 hours
Title
Percentage of time of plasma glucose levels above 10 mmol/L.
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels above 10 mmol/L.
Time Frame
11 hours
Title
Percentage of time of plasma glucose levels above 13.9 mmol/L
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels above 13.9 mmol/L
Time Frame
11 hours
Title
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Time Frame
11 hours
Title
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Time Frame
11 hours
Title
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Time Frame
11 hours
Title
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Time Frame
11 hours
Title
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Time Frame
11 hours
Title
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Time Frame
11 hours
Title
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Time Frame
11 hours
Title
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Time Frame
11 hours
Title
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Time Frame
11 hours
Title
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Time Frame
11 hours
Title
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Time Frame
11 hours
Title
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Time Frame
11 hours
Title
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Time Frame
11 hours
Title
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Time Frame
11 hours
Title
Standard deviation of plasma glucose levels.
Time Frame
11 hours
Title
Standard deviation of sensor glucose levels.
Time Frame
11 hours
Title
Coefficient of variance of plasma glucose levels.
Time Frame
11 hours
Title
Coefficient of variance of sensor glucose levels.
Time Frame
11 hours
Title
Total insulin delivery.
Time Frame
11 hours
Title
Mean plasma glucose level.
Time Frame
11 hours
Title
Mean sensor glucose level.
Time Frame
11 hours
Title
Mean plasma insulin concentration.
Time Frame
11 hours
Title
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Time Frame
11 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 6 months.
HbA1c ≤ 12%.
Exclusion Criteria:
Using a patch-pump (e.g. Omnipod)
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.
Ongoing or planned pregnancy.
Breastfeeding.
Severe hypoglycemic episode within two weeks of screening.
Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
Known or suspected allergy to the trial products or meal contents.
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
Problems with venous access.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remi Rabasa-Lhoret
Organizational Affiliation
Institut de recherches cliniques de Montréal
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
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