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

NCT03542682 | Completed Results FDA Device

• 1 other identifier: 2000022726
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• Time to Maximum Glucose Infusion Rate

  time to maximum glucose infusion rate (GIR) in minutes

  300 minutes

Secondary Outcomes (3)

• Earlier Clearance of Exogenous Insulin.

  up to 5 hours

• Maximum Glucose Infusion Rate

  300 minutes

• Area Under the Curve for the Glucose Infusion Rate

  300 minutes

Study Arms (2)

Individuals given Standard Bolus first, then quick bolus

ACTIVE COMPARATOR

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

Device: Quick Bolus; Device: Standard Bolus

Individuals given Quick bolus first, then standard bolus

ACTIVE COMPARATOR

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

Device: Quick Bolus; Device: Standard Bolus

Interventions

Quick Bolus DEVICE

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.

Individuals given Quick bolus first, then standard bolus; Individuals given Standard Bolus first, then quick bolus

Standard Bolus DEVICE

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.

Individuals given Quick bolus first, then standard bolus; Individuals given Standard Bolus first, then quick bolus

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Results Point of Contact

• Title: Laura Marie Nally, MD
• Organization: Yale School of Medicine

laura.nally@yale.edu

(877) 925-3637

Study Officials

• Eda Cengiz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 31, 2018
• Study Start: May 30, 2018
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)