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

I

Institut de Recherches Cliniques de Montreal

Status and phase

Withdrawn
Phase 2

Conditions

Type 1 Diabetes Mellitus

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03335501
CLASS-FiAsp

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

0 participants in 2 patient groups

Rapid-acting Aspart
Active Comparator group
Description:
Rapid-acting Aspart will be used to regulate glucose levels
Treatment:
Device: Insulin pump
Device: Continuous glucose monitoring system
Other: 11-hour intervention with the single-hormone artificial pancreas
Faster insulin Aspart
Active Comparator group
Description:
Faster insulin Aspart will be used to regulate glucose levels
Treatment:
Device: Insulin pump
Device: Continuous glucose monitoring system
Other: 11-hour intervention with the single-hormone artificial pancreas

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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