Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia and Hyperglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Animas Corporation
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research setting.
Detailed Description
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 21-65 years
- •type 1 diabetes mellitus for at least one year
- •Currently using an insulin infusion pump for at least the past 6 months
Exclusion Criteria
- •Pregnancy
- •History of Diabetic Ketoacidosis (DKA) in the past six months
- •Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months
Outcomes
Primary Outcomes
Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Time Frame: After subject is discharged from CRC, 1 week after enrolment
Secondary Outcomes
- Number of Safety Events and any additional information that can be used for product development(After subject is discharged from CRC, 1 week after enrolment)