NCT02333864

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

December 17, 2014

Last Update Submit

May 26, 2015

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.

    Lay-user accuracy

    Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)

  • Accuracy Verification of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.

    HCP accuracy

    Blood glucose measured at time of single visit for each subject, endpoint evaluated at completion of study (approximately four months after initiation.)

Study Arms (1)

PWD testing POGO® BGMS

All enrolled persons with diabetes

Device: POGO® BGMS

Interventions

POGO® BGMSDEVICE

SMBG

PWD testing POGO® BGMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who are 18 years of age or older and have been diagnosed with diabetes

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diablo Clinical Reasearch

Walnut Creek, California, 94598, United States

Location

Park Nicollett Institute - International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

January 7, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(2)