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

NCT ID: NCT03335501

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-12-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rapid-acting Aspart

Rapid-acting Aspart will be used to regulate glucose levels

Group Type: ACTIVE_COMPARATOR

Insulin pump

Intervention Type: DEVICE

The participant's insulin pump will be used to infuse insulin

Continuous glucose monitoring system

Intervention Type: DEVICE

The Dexcom G4 Platinum will be used to measure glucose levels

11-hour intervention with the single-hormone artificial pancreas

Intervention Type: OTHER

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.

Faster insulin Aspart

Faster insulin Aspart will be used to regulate glucose levels

Group Type: ACTIVE_COMPARATOR

Insulin pump

Intervention Type: DEVICE

The participant's insulin pump will be used to infuse insulin

Continuous glucose monitoring system

Intervention Type: DEVICE

The Dexcom G4 Platinum will be used to measure glucose levels

11-hour intervention with the single-hormone artificial pancreas

Intervention Type: OTHER

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.

Interventions

Insulin pump

The participant's insulin pump will be used to infuse insulin

Intervention Type: DEVICE

Continuous glucose monitoring system

The Dexcom G4 Platinum will be used to measure glucose levels

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Remi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Other Identifiers

CLASS-FiAsp

Identifier Type: -

Identifier Source: org_study_id