A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | November 8, 2017 |
| End Date: | February 9, 2018 |
An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
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.
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.
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
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