NCT02345967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

3.4 years

First QC Date

January 20, 2015

Last Update Submit

June 11, 2018

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus requiring insulin

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    Incidence of adverse events related to the Intervention

    From enrollment to 2-weeks post-explant

Study Arms (1)

Study Group

EXPERIMENTAL

Device: Model 100 Sensor

Device: Model 100 Sensor

Interventions

Model 100 SensorDEVICE

One Model 100 Sensor to be implanted per subject.

Study Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

AMCR Institute

Escondido, California, 92025, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Linda Morrow, MD

    Profil Institute for Clinical Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

June 13, 2018

Record last verified: 2018-06

Locations

US(2)