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Function of Implanted Glucose Sensor 2 (FIGS-2)

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
Sponsor:
Collaborators:
Profil Institute for Clinical Research, Inc.
AMCR Institute
Information provided by (Responsible Party):
GlySens Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Model 100 Sensor Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Group
Device: Model 100 Sensor
 Device: Model 100 Sensor
One Model 100 Sensor to be implanted per subject.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: From enrollment to 2-weeks post-explant ]
    Incidence of adverse events related to the Intervention


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
AMCR Institute
Escondido, California, United States, 92025
Sponsors and Collaborators
GlySens Incorporated
Profil Institute for Clinical Research, Inc.
AMCR Institute
Investigators
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Principal Investigator: Linda Morrow, MD Profil Institute for Clinical Research, Inc.
More Information
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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
Keywords provided by GlySens Incorporated:
diabetes mellitus requiring insulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases