Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOQS | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to.
This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges | Up to 4 hours post challenge | |
| Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge | Up to 4 hours post challenge | |
| Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity | Up to 4 hours post challenge |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Renton | Washington | 98057 |
Not provided
| Label | URL |
|---|---|
| A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM) | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
|
| United States |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |