Function of Implanted Glucose Sensor 2
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 6/15/2018 |
| Start Date: | January 2015 |
| End Date: | May 30, 2018 |
The purpose of this study is to verify safety and assess tolerance of a long-term, implanted
glucose monitoring sensor. The study will also provide data to characterize the response
properties and calibration of the implanted sensor and determine if such properties vary with
implant duration.
glucose monitoring sensor. The study will also provide data to characterize the response
properties and calibration of the implanted sensor and determine if such properties vary with
implant duration.
Inclusion Criteria:
- Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become
pregnant
- Diabetes diagnosis of type 1, or type 2 using insulin
- Under the routine care of a physician for diabetes treatment
- Able to understand and follow directions
- History of compliance with diabetes care regimen
- Able to comply with study requirements regarding planned clinical visits and exams
- In good physical condition without major medical concerns or blood chemistry
abnormalities
Exclusion Criteria:
- Mental disorders that might affect compliance to protocols
- Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin
or (2) insulin use restricted to a single daily injection of long-acting insulin or
(3) control by diet/exercise regimen alone
- History of intolerance or sensitivity to any of the device materials
- History of any adverse reaction or allergy to any of the drugs/agents utilized in the
study procedures
- History of recurrent skin infections
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