Status:
COMPLETED
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
Lead Sponsor:
Animas Corporation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
21-65 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- Summary of Key inclusion/exclusion 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01401751
Start Date
July 1 2011
End Date
December 1 2011
Last Update
February 3 2025
Active Locations (1)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105