POGO® Automatic Blood Glucose Monitoring System Clinical Study

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if the POGO® system delivers accurate blood glucose readings in the hands of the lay user and assess the POGO® system accuracy when used by trained health care professionals.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blood Glucose Monitoring System Clinical Study

NCT01327209

Diabetes

COMPLETED

Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

NCT02041286

Diabetes

COMPLETED NA

Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System

NCT02041377

Diabetes

COMPLETED NA

Study of an Investigational Glucose Meter System

NCT01466075

Diabetes

COMPLETED NA

Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device

NCT01508065

Diabetes Mellitus Type 1

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects will review labeling materials and self-test using the POGO® system. An HCP-assisted test also will be performed; both tests will be compared to a fingerstick capillary sample run on a YSI reference glucose analyzer. Subjects will complete questionnaires on labeling comprehension and POGO® usability.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PWD testing POGO® BGMS

All enrolled persons with diabetes

POGO® BGMS

Intervention Type DEVICE

SMBG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

POGO® BGMS

SMBG

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be diagnosed with diabetes
* Be 18 years of age or older
* Be able to read, write, and understand English fluently
* Be able and willing to give written informed consent and have provided signed, written consent

Exclusion Criteria

* Any condition which in the opinion of the Investigator may place the subject or site personnel at excessive risk
* A physical condition or limitation that prevents the subject from reading the labeling and using a BGMS on their own
* Previous experience with the POGO® BGMS
* Formal experience with clinical (medical) laboratory equipment or formal training in a relevant medical field

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No