Type 1 Diabetes Mellitus
Conditions
Brief summary
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 designed. The study will last about 3 months with up to 6 days of inpatient time.
Interventions
DEVICEAID System
AID system
DRUGInsulin Lispro
Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months * Have a body mass index of 18.5 to 37 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) | In-Patient Period (6 Days) | Number of AEs |
| Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL | In-Patient Period (6 Days) | CGM measured percentage of time \<70 milligrams per deciliter (mg/dL) |
Countries
United States
Outcome results
None listed