Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Insulin Pump
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.
Interventions
DEVICEPredictive Low Glucose Minimizer
This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators 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.
Sponsors
Animas Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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 * History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed