The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    15
  • sponsor
    Yale University
Updated on 25 March 2022
Accepts healthy volunteers

Summary

Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.

Description

The investigators hypothesize that RAI absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate during the clamp study will be significantly faster when insulin bolus is delivered using the "Quick Bolus" feature as compared to the "Standard Bolus".

Details
Condition Type1diabetes
Treatment Quick Bolus, Standard Bolus
Clinical Study IdentifierNCT03542682
SponsorYale University
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 - 30 (inclusive)
Clinical diagnosis of T1D of at least one year's duration
On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months
HbA1c <10%
Minimum weight requirement of at least 37.9 kg
Ability to comprehend written and spoken English
Total daily requirement of insulin between 0.6 and1.2 U/kg/day
Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism

Exclusion Criteria

Medication besides insulin known to alter blood glucose or insulin action
Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception
Inability to comprehend written and spoken English
Any other condition, which in the judgment of the investigators, would interfere with the subject's ability to provide informed consent or the investigator's ability to perform the study
Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L
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