New Haven, Connecticut 06520

  • Type1diabetes

Purpose:

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


Study summary:

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".


Criteria:

Inclusion Criteria: 1. Age 18 - 30 (inclusive) 2. Clinical diagnosis of T1D of at least one year's duration 3. On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months 4. HbA1c <10% 5. Minimum weight requirement of at least 37.9 kg 6. Ability to comprehend written and spoken English 7. Total daily requirement of insulin between 0.6 and1.2 U/kg/day 8. Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism Exclusion Criteria: 1. Medication besides insulin known to alter blood glucose or insulin action 2. Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception. 3. Inability to comprehend written and spoken English 4. 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 5. Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L


NCT ID:

NCT03542682


Primary Contact:

Principal Investigator
Eda Cengiz, MD
Yale University

Lori Carria
Phone: 203-737-3595
Email: lori.carria@yale.edu


Backup Contact:

Email: eda.cengiz@yale.edu
Eda Cengiz, MD
Phone: 203-785-7163


Location Contact:

New Haven, Connecticut 06520
United States

Lori Carria, MS
Phone: 203-737-3595

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

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