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

Primary Purpose

Type1diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Quick Bolus

Standard Bolus

About this trial

This is an interventional basic science trial for Type1diabetes

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Individuals given Standard Bolus

Individuals given Quick bolus

Arm Description

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

Outcomes

Primary Outcome Measures

time to reach 25% maximum insulin levels

RAI absorption time to reach 25% maximum insulin levels

Secondary Outcome Measures

Earlier clearance of exogenous insulin.

Examine if an alteration in speed of insulin delivery translates into a time to peak glucose infusion rate (amount of glucose given via dextrose infusion) to maintain euglycemia (80-120 mg/dl). The investigators will obtain a blood glucose every 5 minutes and adjust the dextrose infusion to maintain a blood glucose at around 90 - 100 mg/dL (normal blood glucose). So the goal will not be to lower blood glucose, but to deliver an amount of insulin at a normal blood glucose and then provide intravenous glucose at variable rates and determine how much glucose was needed to keep blood sugar steady.

Full Information

NCT ID

NCT03542682

First Posted

April 30, 2018

Last Updated

August 4, 2023

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT03542682

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

May 30, 2018 (Actual)

Primary Completion Date

September 23, 2022 (Actual)

Study Completion Date

September 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.

Masking

Participant

Masking Description

single blinded

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individuals given Standard Bolus

Arm Type

Active Comparator

Arm Description

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

Arm Title

Individuals given Quick bolus

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Quick Bolus

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Standard Bolus

Intervention Description

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.

Primary Outcome Measure Information:

Title

time to reach 25% maximum insulin levels

Description

RAI absorption time to reach 25% maximum insulin levels

Time Frame

5 minutes

Secondary Outcome Measure Information:

Title

Earlier clearance of exogenous insulin.

Description

Time Frame

up to 5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eda Cengiz, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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