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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03335501
• Other study ID #: CLASS-FiAsp
• Status: Withdrawn
• Phase: Phase 2
• First received: November 3, 2017
• Last updated: April 25, 2018
• Start date: April 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2018
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Insulin pump
The participant's insulin pump will be used to infuse insulin
• Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels

Other:
• 11-hour intervention with the single-hormone artificial pancreas
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Outcome

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