A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03367390 |
Recruitment Status :
Completed
First Posted : December 8, 2017
Last Update Posted : March 15, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type1 Diabetes Mellitus | Device: AID System Drug: Insulin Lispro | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus |
Actual Study Start Date : | November 8, 2017 |
Actual Primary Completion Date : | February 9, 2018 |
Actual Study Completion Date : | February 9, 2018 |

Arm | Intervention/treatment |
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Experimental: AID System Containing Insulin Lispro
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.
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Device: AID System
AID system
Other Name: LY8888AU Drug: Insulin Lispro Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other Name: LY275585 |
- Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges [ Time Frame: Up to 4 hours post challenge ]
- Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge [ Time Frame: Up to 4 hours post challenge ]
- Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity [ Time Frame: Up to 4 hours post challenge ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants with T1DM for at least 2 years and who have used an insulin delivery system for at least 1 year
- Have a body mass index of 18.5 to 35 kilogram per meter squared
- Have a hemoglobin A1c level ≥6.0% and ≤9.0%
Exclusion Criteria:
- Have known allergies or history of hypersensitivity to insulin lispro
- Have had an episode of severe hypoglycemia within the past 6 months
- Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367390
United States, Washington | |
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, United States, 98057 |
Study Director: | 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 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03367390 |
Other Study ID Numbers: |
16679 F3Z-MC-IOQS ( Other Identifier: Eli Lilly and Company ) |
First Posted: | December 8, 2017 Key Record Dates |
Last Update Posted: | March 15, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |