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

Phase 2

Withdrawn

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Insulin pump; Device: Continuous glucose monitoring system; Other: 11-hour intervention with the single-hormone artificial pancreas

• Registration Number: NCT03335501
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Status Verified: 2018-04
• Study Start: 2018-04-01
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-27
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rapid-acting Aspart	Insulin pump	Rapid-acting Aspart will be used to regulate glucose levels
Rapid-acting Aspart	Continuous glucose monitoring system	Rapid-acting Aspart will be used to regulate glucose levels
Faster insulin Aspart	Continuous glucose monitoring system	Faster insulin Aspart will be used to regulate glucose levels
Faster insulin Aspart	11-hour intervention with the single-hormone artificial pancreas	Faster insulin Aspart will be used to regulate glucose levels
Rapid-acting Aspart	11-hour intervention with the single-hormone artificial pancreas	Rapid-acting Aspart will be used to regulate glucose levels
Faster insulin Aspart	Insulin pump	Faster insulin Aspart will be used to regulate glucose levels

Primary Outcome Measures

Name	Time	Method
Change in plasma glucose levels 1 hour after the meal	1 hour

Secondary Outcome Measures

Name	Time	Method
Standard deviation of plasma glucose levels.	11 hours
Change in plasma glucose levels 2 hours after the meal.	2 hours
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.	4 hours
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.	11 hours
Percentage of time of sensor glucose levels below 2.8 mmol/L.	11 hours
Percentage of time of sensor glucose levels above 10 mmol/L.	11 hours
Area under the curve of plasma glucose levels for the 2-hour period following the meal.	2 hours
Glycemic peak in the 3 hours following the meal.	3 hours
Peak time of glucose levels over the 4 hours following the meal.	4 hours
Area under the curve of plasma glucose levels for the 1-hour period following the meal.	1 hour
Percentage of time of sensor glucose levels below 3.9 mmol/L.	11 hours
Percentage of time of plasma glucose levels below 3.3 mmol/L.	11 hours
Percentage of time of plasma glucose levels above 10 mmol/L.	11 hours
Percentage of time of sensor glucose levels above 16.7 mmol/L.	11 hours
Area under the curve of plasma glucose levels below 3.9 mmol/L.	11 hours
Area under the curve of sensor glucose levels above 10.0 mmol/L.	11 hours
Area under the curve of plasma glucose levels above 13.9 mmol/L.	11 hours
Area under the curve of sensor glucose levels above 13.9 mmol/L.	11 hours
Coefficient of variance of sensor glucose levels.	11 hours
Mean plasma glucose level.	11 hours
Mean plasma insulin concentration.	11 hours
Plasma glucose level 1 hour after the meal.	1 hour
Plasma glucose level 2 hours after the meal.	2 hours
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.	11 hours
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.	11 hours
Percentage of time of sensor glucose levels below 3.3 mmol/L.	11 hours
Percentage of time of plasma glucose levels above 13.9 mmol/L	11 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L.	11 hours
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.	11 hours
Percentage of time of sensor glucose levels above 13.9 mmol/L	11 hours
Area under the curve of sensor glucose levels below 3.9 mmol/L.	11 hours
Area under the curve of plasma glucose levels below 2.8 mmol/L.	11 hours
Area under the curve of plasma glucose levels above 16.7 mmol/L.	11 hours
Mean sensor glucose level.	11 hours
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).	11 hours
Percentage of time of plasma glucose levels below 3.9 mmol/L.	11 hours
Percentage of time of plasma glucose levels below 2.8 mmol/L.	11 hours
Percentage of time of plasma glucose levels above 16.7 mmol/L.	11 hours
Area under the curve of sensor glucose levels below 3.3 mmol/L.	11 hours
Area under the curve of sensor glucose levels above 16.7 mmol/L.	11 hours
Standard deviation of sensor glucose levels.	11 hours
Total insulin delivery.	11 hours
Area under the curve of plasma glucose levels below 3.3 mmol/L.	11 hours
Area under the curve of sensor glucose levels below 2.8 mmol/L.	11 hours
Coefficient of variance of plasma glucose levels.	11 hours