Blood Glucose Monitoring System Clinical Study

NCT ID: NCT01327209

Last Updated: 2011-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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Verify the following with blood glucose monitoring system:

* precision and accuracy versus YSI reference
* user evaluation
* labeling comprehension

Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diabetes

No interventions assigned to this group

Eligibility Criteria

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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

* Subject does not agree to test for infectious diseases per clinical protocol

Exclusion Criteria

* Inability to provide Informed Consent
* Subject's physical condition/limitation prevents the person from using a BGMS on their own
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuity Medical, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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International Diabetes Center

Principal Investigators

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Richard Bergenstal, MD

Role: PRINCIPAL_INVESTIGATOR

Park Nicollett Institue - International Diabetes Center

Locations

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University of San Diego

San Diego, California, United States

Site Status

University of Miami - School of Medicine

Miami, Florida, United States

Site Status

Park Nicollett Institute - International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

Cetero Research DGD

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TP-0000145

Identifier Type: -

Identifier Source: org_study_id

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