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

Yale University

Status: Completed

Conditions: Type1diabetes

Treatments: Device: Quick Bolus; Device: Standard Bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT03542682

2000022726

Details and patient eligibility

About

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

Full 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".

Outcomes were updated at time of results entry.

Enrollment: 11 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Individuals given Standard Bolus first, then quick bolus

Active Comparator group

Description:

Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.

Treatment:

Device: Standard Bolus

Device: Quick Bolus

Individuals given Quick bolus first, then standard bolus

Active Comparator group

Description:

Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.

Treatment:

Device: Standard Bolus

Device: Quick Bolus