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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | non-randomized, uncontrolled, feasibility study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglycemia-Hyperglycemia Minimizer System | Device | Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. | 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. | End of Study - in approximately 5 months from first subject enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | Measuring the following:
| End of Study - in approximately 5 months from first subject enrolled |
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Summary of Key inclusion/exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Other Inclusion/Exclusion criteria apply.
Please contact clinical study site for complete details.
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| Name | Affiliation | Role |
|---|---|---|
| Howard Zisser, MD | Sansum Diabetes Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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