Diabetes Mellitus
Conditions
Keywords
diabetes mellitus requiring insulin
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.
Interventions
DEVICEModel 100 Sensor
One Model 100 Sensor to be implanted per subject.
Sponsors
Profil Institute for Clinical Research, Inc.
AMCR Institute
GlySens Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | From enrollment to 2-weeks post-explant | Incidence of adverse events related to the Intervention |
Countries
United States
Outcome results
None listed