Clinical trial NCT03335501: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Closed-loop control
Artificial pancreas
Postprandial glucose control
Insulin
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in plasma glucose levels 1 hour after the meal
timeFrame: 1 hour
Secondary outcomes:
measure: Area under the curve of plasma glucose levels for the 1-hour period following the meal.
timeFrame: 1 hour
measure: Area under the curve of plasma glucose levels for the 2-hour period following the meal.
timeFrame: 2 hours
measure: Plasma glucose level 1 hour after the meal.
timeFrame: 1 hour
measure: Plasma glucose level 2 hours after the meal.
timeFrame: 2 hours
measure: Glycemic peak in the 3 hours following the meal.
timeFrame: 3 hours
measure: Change in plasma glucose levels 2 hours after the meal.
timeFrame: 2 hours
measure: Peak time of glucose levels over the 4 hours following the meal.
timeFrame: 4 hours
measure: Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
timeFrame: 4 hours
measure: Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of plasma glucose levels below 3.9 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels below 3.9 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of plasma glucose levels below 3.3 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels below 3.3 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of plasma glucose levels below 2.8 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels below 2.8 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of plasma glucose levels above 10 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels above 10 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of plasma glucose levels above 13.9 mmol/L
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels above 13.9 mmol/L
timeFrame: 11 hours
measure: Percentage of time of plasma glucose levels above 16.7 mmol/L.
timeFrame: 11 hours
measure: Percentage of time of sensor glucose levels above 16.7 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of plasma glucose levels below 3.9 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of sensor glucose levels below 3.9 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of plasma glucose levels below 3.3 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of sensor glucose levels below 3.3 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of plasma glucose levels below 2.8 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of sensor glucose levels below 2.8 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of plasma glucose levels above 10.0 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of sensor glucose levels above 10.0 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of plasma glucose levels above 13.9 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of sensor glucose levels above 13.9 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of plasma glucose levels above 16.7 mmol/L.
timeFrame: 11 hours
measure: Area under the curve of sensor glucose levels above 16.7 mmol/L.
timeFrame: 11 hours
measure: Standard deviation of plasma glucose levels.
timeFrame: 11 hours
measure: Standard deviation of sensor glucose levels.
timeFrame: 11 hours
measure: Coefficient of variance of plasma glucose levels.
timeFrame: 11 hours
measure: Coefficient of variance of sensor glucose levels.
timeFrame: 11 hours
measure: Total insulin delivery.
timeFrame: 11 hours
measure: Mean plasma glucose level.
timeFrame: 11 hours
measure: Mean sensor glucose level.
timeFrame: 11 hours
measure: Mean plasma insulin concentration.
timeFrame: 11 hours
measure: Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
timeFrame: 11 hours
Other outcomes:
Locations:
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Remi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: