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

NCT03335501 | Withdrawn Phase 2

• 1 other identifier: CLASS-FiAsp
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Closed-loop control; Artificial pancreas; Postprandial glucose control; Insulin

Outcome Measures

Primary Outcomes (1)

• Change in plasma glucose levels 1 hour after the meal

  1 hour

Secondary Outcomes (45)

• Area under the curve of plasma glucose levels for the 1-hour period following the meal.

  1 hour

• Area under the curve of plasma glucose levels for the 2-hour period following the meal.

  2 hours

• Plasma glucose level 1 hour after the meal.

  1 hour

• Plasma glucose level 2 hours after the meal.

  2 hours

• Glycemic peak in the 3 hours following the meal.

  3 hours

Study Arms (2)

Rapid-acting Aspart

ACTIVE COMPARATOR

Rapid-acting Aspart will be used to regulate glucose levels

Device: Insulin pump; Device: Continuous glucose monitoring system; Other: 11-hour intervention with the single-hormone artificial pancreas

Faster insulin Aspart

ACTIVE COMPARATOR

Faster insulin Aspart will be used to regulate glucose levels

Device: Insulin pump; Device: Continuous glucose monitoring system; Other: 11-hour intervention with the single-hormone artificial pancreas

Interventions

Insulin pump DEVICE

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

Faster insulin Aspart; Rapid-acting Aspart

Continuous glucose monitoring system DEVICE

The Dexcom G4 Platinum will be used to measure glucose levels

Faster insulin Aspart; Rapid-acting Aspart

11-hour intervention with the single-hormone artificial pancreas 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; Rapid-acting Aspart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Insulin Infusion Systems; Continuous Glucose Monitoring; Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Remi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: April 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04