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

Not Applicable

Completed

• Conditions: Type1diabetes
• Interventions: Device: Quick Bolus; Device: Standard Bolus

• Registration Number: NCT03542682
• Lead Sponsor: Yale University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-30
• Study Start: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Primary Completion: 2022-09-23
• Study Completion: 2022-09-23
• Disposition First Submitted: 2023-07-03
• Results First Submitted: 2023-12-21
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Results First Posted: 2024-02-13
• Disposition First Posted: 2024-02-13
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Individuals given Quick bolus first, then standard bolus	Quick Bolus	Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
Individuals given Standard Bolus first, then quick bolus	Standard Bolus	Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
Individuals given Quick bolus first, then standard bolus	Standard Bolus	Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
Individuals given Standard Bolus first, then quick bolus	Quick Bolus	Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.

Primary Outcome Measures

Name	Time	Method
Time to Maximum Glucose Infusion Rate	300 minutes	time to maximum glucose infusion rate (GIR) in minutes

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve for the Glucose Infusion Rate	300 minutes	area under the curve for the glucose infusion rate
Earlier Clearance of Exogenous Insulin.	up to 5 hours	Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability.
Maximum Glucose Infusion Rate	300 minutes	maximum glucose infusion rate (GIRmax)

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States