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Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals given Standard Bolus first, then quick bolus | Active Comparator | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. |
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| Individuals given Quick bolus first, then standard bolus | Active Comparator | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Glucose Infusion Rate | time to maximum glucose infusion rate (GIR) in minutes | 300 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Earlier Clearance of Exogenous Insulin. | Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability. | up to 5 hours |
| Maximum Glucose Infusion Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eda Cengiz, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States |
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11 participants consented to participate but 2 were lost to follow up prior to randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Individuals Given Standard Bolus First, Then Quick Bolus | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. 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. 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. |
| FG001 | Individuals Given Quick Bolus First, Then Standard Bolus | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline demographics were collected from the 8 who completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Individuals Given Standard Bolus First, Then Quick Bolus | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Maximum Glucose Infusion Rate | time to maximum glucose infusion rate (GIR) in minutes | Complete case analysis | Posted | Least Squares Mean | 95% Confidence Interval | minutes | 300 minutes |
|
Up to 5 hours post intervention for each intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individuals Given Standard Bolus | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common Cold | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Marie Nally, MD | Yale School of Medicine | (877) 925-3637 | laura.nally@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2021 | Dec 20, 2023 | Prot_SAP_000.pdf |
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This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
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single blinded
| 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. |
|
maximum glucose infusion rate (GIRmax)
| 300 minutes |
| Area Under the Curve for the Glucose Infusion Rate | area under the curve for the glucose infusion rate | 300 minutes |
| BG001 | Individuals Given Quick Bolus First, Then Standard Bolus | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline mean percent Hemoglobin A1c | Mean | Standard Deviation | percent Hemoglobin A1c |
|
|
|
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| Secondary | Earlier Clearance of Exogenous Insulin. | Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability. | Outcome was not part of the study protocol and therefore was not collected. | Posted | up to 5 hours |
|
|
| Secondary | Maximum Glucose Infusion Rate | maximum glucose infusion rate (GIRmax) | Complete case analysis. | Posted | Least Squares Mean | 95% Confidence Interval | mg/kg/min | 300 minutes |
|
|
|
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| Secondary | Area Under the Curve for the Glucose Infusion Rate | area under the curve for the glucose infusion rate | Posted | Least Squares Mean | 95% Confidence Interval | mg/kg | 300 minutes |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Individuals Given Quick Bolus | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. 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. | 0 | 9 | 0 | 9 | 1 | 9 |
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