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OpenTrials
Completed

NCT Number: NCT02345967

Function of Implanted Glucose Sensor 2

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Profil Institute for Clinical Research, Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Model 100 Sensor

Device

One Model 100 Sensor to be implanted per subject.

Primary outcomes

  1. Number of Adverse Events

    Time frame: From enrollment to 2-weeks post-explant

    Incidence of adverse events related to the Intervention

Sponsors and collaborators

Lead sponsor

GlySens Incorporated

Industry

Collaborators

  • AMCR Institute
  • Profil Institute for Clinical Research, Inc.

Registry information

Acronym: FIGS-2

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2015
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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