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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypo-Hyper Minimizer (HHM) System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypo-Hyper Minimizer (HHM) System | Device | Adjustment of Insulin dosing during meal time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. | After subject is discharged from CRC, 1 week after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Safety Events and any additional information that can be used for product development | After subject is discharged from CRC, 1 week after enrolment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Anhalt, DO | Animas Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsum Diabetes Reserach Inst. | Santa Barbara | California | 93105 | United States | ||
| UVA Diabetes Technology Center |
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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 |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Charlottesville |
| Virginia |
| 22903 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |