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

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ClinicalTrials.gov Identifier: NCT03542682
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Type1diabetes Device: Quick Bolus Device: Standard Bolus Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
Masking: Single (Participant)
Masking Description: single blinded
Primary Purpose: Basic Science
Official Title: The Effect of Insulin Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Active Comparator: Individuals given Standard Bolus
Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
Device: 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.

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




Primary Outcome Measures :
  1. time to reach 25% maximum insulin levels [ Time Frame: 5 minutes ]
    RAI absorption time to reach 25% maximum insulin levels


Secondary Outcome Measures :
  1. Earlier clearance of exogenous insulin. [ Time Frame: up to 5 hours ]
    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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542682


Contacts
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Contact: Lori Carria 203-737-3595 lori.carria@yale.edu
Contact: Eda Cengiz, MD 203-785-7163 eda.cengiz@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Lori Carria, MS    203-737-3595      
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Kathryn Gibbons, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03542682     History of Changes
Other Study ID Numbers: 2000022726
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs