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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Withdrawn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
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females ≥ 18 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. The subject will have been on insulin pump therapy for at least 6 months.
  4. HbA1c ≤ 12%.

Exclusion Criteria:

  1. Using a patch-pump (e.g. Omnipod)
  2. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  3. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  4. Ongoing or planned pregnancy.
  5. Breastfeeding.
  6. Severe hypoglycemic episode within two weeks of screening.
  7. Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
  8. Known or suspected allergy to the trial products or meal contents.
  9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  10. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
  11. 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

    First Posted
    November 3, 2017
    Last Updated
    April 25, 2018
    Sponsor
    Institut de Recherches Cliniques de Montreal
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    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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