Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia
- Conditions
- Type 1 Diabetes
- Interventions
- Device: Predictive Low Glucose Minimizer
- Registration Number
- NCT01919385
- Lead Sponsor
- Animas Corporation
- Brief Summary
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- Pregnancy
- History of Diabetic Ketoacidosis (DKA) in the past six months
- History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description type 1 diabetes Predictive Low Glucose Minimizer Predictive Low Glucose Minimizer (PLGM) System
- Primary Outcome Measures
Name Time Method Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting 1 week after subject is enrolled in the study Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold.
Ability of the system to issue timely and accurate warnings.
- Secondary Outcome Measures
Name Time Method Capturing the number of Adverse Events as a measure of assessing subject safety 1 week after subject is enrolled in the study Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.
Trial Locations
- Locations (1)
Samsum Diabetes Reserach Inst.
🇺🇸Santa Barbara, California, United States