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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IORC | Other Identifier | Eli Lilly and Company |
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The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AID System Containing Insulin Lispro | Experimental | The automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AID System | Device | AID system |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Number of AEs | In-Patient Period (2 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 (2 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 |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33535013 | Derived | Pinsker JE, Bartee A, Katz M, Lalonde A, Jones R, Dassau E, Wolpert H. Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines. Diabetes Technol Ther. 2021 Jul;23(7):512-516. doi: 10.1089/dia.2020.0619. Epub 2021 Feb 18. |
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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. |
|
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| 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 |