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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IORB | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AID System Containing Insulin Lispro | Experimental | The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AID System | Device | AID system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Number of AEs | In-Patient Period (5 Days) |
| Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL | CGM measured percentage of time <70 milligrams per deciliter (mg/dL) | In-Patient Period (5 Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32940537 | Derived | Christiansen M, Bartee A, Lalonde A, Jones RE, Katz M, Wolpert H, Brazg R. Performance of an Automated Insulin Delivery System: Results of Early Phase Feasibility Studies. Diabetes Technol Ther. 2021 Mar;23(3):187-194. doi: 10.1089/dia.2020.0318. Epub 2020 Oct 5. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Lispro | Drug | Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia. |
|
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |