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

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

Detailed Description
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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.

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

Conditions
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Type1diabetes

Intervention / Treatment
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* Device: Quick Bolus
* Device: Standard Bolus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individuals given Standard Bolus<br>Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. | Device: Quick Bolus<br>* 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.<br>Device: Standard Bolus<br>* 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.<br>|
| Active Comparator: Individuals given Quick bolus<br>Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. | Device: Quick Bolus<br>* 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.<br>Device: Standard Bolus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to reach 25% maximum insulin levels | RAI absorption time to reach 25% maximum insulin levels | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 5 hours |