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
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Animas Corporation
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) 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 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results. Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 21-65 years
- •Type 1 diabetes mellitus for at least one year
- •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
- •History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months
- •Other Inclusion/Exclusion criteria apply.
- •Please contact clinical study site for complete details.
Outcomes
Primary Outcomes
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Time Frame: End of Study - in approximately 5 months from first subject enrolled
Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.
Secondary Outcomes
- Safety Evaluation(End of Study - in approximately 5 months from first subject enrolled)