Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 Diabetes Mellitus, Artificial Pancreas
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.
Interventions
DEVICEHypoglycemia-Hyperglycemia Minimizer System
Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm
Sponsors
Animas Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Summary of Key inclusion/
Exclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | End of Study - in approximately 5 months from first subject enrolled | Measuring the following: * the number and type of adverse events, including Adverse device effects, Serious Adverse Events, Unanticipated Adverse Device Effects, device malfunctions * Resulting glucose data from 24 hour clinical research center visit |
Countries
United States
Outcome results
None listed