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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542682
• Other study ID #: 2000022726
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: September 23, 2022

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Outcomes were updated at time of results entry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Device:
• Quick Bolus
Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp.
• Standard Bolus
Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Maximum Glucose Infusion Rate	time to maximum glucose infusion rate (GIR) in minutes	300 minutes
Secondary	Earlier Clearance of Exogenous Insulin.	Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability.	up to 5 hours
Secondary	Maximum Glucose Infusion Rate	maximum glucose infusion rate (GIRmax)	300 minutes
Secondary	Area Under the Curve for the Glucose Infusion Rate	area under the curve for the glucose infusion rate	300 minutes