Function of Implanted Glucose Sensor 2 | NCT02345967

Studies
Function of Implanted Glucose Sensor 2

NCT02345967

Sponsor

GlySens Incorporated

Status

Completed

Last Update Posted

Jun 13, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Model 100 Sensor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

May 30, 2018Actual

Completion Date

May 30, 2018Actual

First Submitted Date

Jan 20, 2015

First Submission Date that Met QC Criteria

Jan 23, 2015

First Posted Date

Jan 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2018

Last Update Posted Date

Jun 13, 2018Actual

Name	Class
Profil Institute for Clinical Research, Inc.	OTHER
AMCR Institute	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Device: Model 100 Sensor	Device: Model 100 Sensor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Model 100 Sensor	Device	One Model 100 Sensor to be implanted per subject.	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Adverse Events	Incidence of adverse events related to the Intervention	From enrollment to 2-weeks post-explant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linda Morrow, MD	Profil Institute for Clinical Research, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Profil Institute for Clinical Research		Chula Vista	California	91911	United States
AMCR Institute

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided