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
Sponsored by
About this trial
This is an interventional basic science trial for Type1diabetes
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
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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.
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
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
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
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.
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
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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