The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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".
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- time to reach 25% maximum insulin levels [5 minutes]
RAI absorption time to reach 25% maximum insulin levels
Secondary Outcome Measures
- Earlier clearance of exogenous insulin. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 - 30 (inclusive)
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Clinical diagnosis of T1D of at least one year's duration
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On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months
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HbA1c <10%
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Minimum weight requirement of at least 37.9 kg
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Ability to comprehend written and spoken English
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Total daily requirement of insulin between 0.6 and1.2 U/kg/day
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Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism
Exclusion Criteria:
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Medication besides insulin known to alter blood glucose or insulin action
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Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception.
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Inability to comprehend written and spoken English
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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
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Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University | New Haven | Connecticut | United States | 06520 |
Sponsors and Collaborators
- Yale University
Investigators
- Principal Investigator: Eda Cengiz, MD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000022726