Blood Glucose Monitoring System Clinical Study | NCT01327209

Studies
Blood Glucose Monitoring System Clinical Study

NCT01327209

Sponsor

Intuity Medical, Inc

Status

Completed

Last Update Posted

Jun 9, 2011Estimated

Enrollment

202Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Not provided

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 2011

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

Dec 2010

Primary Completion Date

Not provided

Completion Date

Apr 2011Actual

First Submitted Date

Mar 30, 2011

First Submission Date that Met QC Criteria

Mar 31, 2011

First Posted Date

Apr 1, 2011Estimated

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 8, 2011

Last Update Posted Date

Jun 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Verify the following with blood glucose monitoring system:

precision and accuracy versus YSI reference
user evaluation
labeling comprehension

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Label	Type	Description	Intervention Names
Patients with diabetes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be diagnosed with Diabetes
Be between 12 and 70 years of age
Be able to read, write, and understand English
Be able and willing to give Informed Consent
Have used an SMBG meter system for at least one year
Be currently testing blood glucose levels at least once per day

Exclusion Criteria:

Inability to provide Informed Consent
Subject does not meet Inclusion Criteria
Subject does not agree to test for infectious diseases per clinical protocol
Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol
Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk
Subject's physical condition/limitation prevents the person from using a BGMS on their own

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

People who have been diagnosed with diabetes and are testing their blood glucose level at least once per day.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Bergenstal, MD	Park Nicollett Institue - International Diabetes Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of San Diego		San Diego	California	92161	United States
University of Miami - School of Medicine

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