Function of Implanted Glucose Sensor 2 (FIGS-2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02345967 |
Recruitment Status :
Completed
First Posted : January 26, 2015
Last Update Posted : June 13, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus | Device: Model 100 Sensor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Function of Implanted Glucose Sensor 2 |
Study Start Date : | January 2015 |
Actual Primary Completion Date : | May 30, 2018 |
Actual Study Completion Date : | May 30, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Study Group
Device: Model 100 Sensor
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Device: Model 100 Sensor
One Model 100 Sensor to be implanted per subject. |
- Number of Adverse Events [ Time Frame: From enrollment to 2-weeks post-explant ]Incidence of adverse events related to the Intervention

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Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345967
United States, California | |
Profil Institute for Clinical Research | |
Chula Vista, California, United States, 91911 | |
AMCR Institute | |
Escondido, California, United States, 92025 |
Principal Investigator: | Linda Morrow, MD | Profil Institute for Clinical Research, Inc. |
Responsible Party: | GlySens Incorporated |
ClinicalTrials.gov Identifier: | NCT02345967 |
Other Study ID Numbers: |
PR13-004 |
First Posted: | January 26, 2015 Key Record Dates |
Last Update Posted: | June 13, 2018 |
Last Verified: | June 2018 |
diabetes mellitus requiring insulin |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |