Function of Implanted Glucose Sensor 2
Not Applicable
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Model 100 Sensor
- Registration Number
- NCT02345967
- Lead Sponsor
- GlySens Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Group Model 100 Sensor Device: Model 100 Sensor
- Primary Outcome Measures
Name Time Method Number of Adverse Events From enrollment to 2-weeks post-explant Incidence of adverse events related to the Intervention
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Profil Institute for Clinical Research
🇺🇸Chula Vista, California, United States
AMCR Institute
🇺🇸Escondido, California, United States