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Completed

NCT Number: NCT03542682

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

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

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time to Maximum Glucose Infusion Rate

    Time frame: 300 minutes

    time to maximum glucose infusion rate (GIR) in minutes

Secondary outcomes

  1. Earlier Clearance of Exogenous Insulin.

    Time frame: up to 5 hours

    Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability.

  2. Maximum Glucose Infusion Rate

    Time frame: 300 minutes

    maximum glucose infusion rate (GIRmax)

  3. Area Under the Curve for the Glucose Infusion Rate

    Time frame: 300 minutes

    area under the curve for the glucose infusion rate

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 31, 2018
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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