POGO® Automatic Blood Glucose Monitoring System Clinical... | NCT02333864

Studies
POGO® Automatic Blood Glucose Monitoring System Clinical Study

NCT02333864

Sponsor

Intuity Medical, Inc

Status

Completed

Last Update Posted

May 28, 2015Estimated

Enrollment

287Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

POGO® BGMS

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

May 2015

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 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Dec 17, 2014

First Submission Date that Met QC Criteria

Jan 5, 2015

First Posted Date

Jan 7, 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

May 26, 2015

Last Update Posted Date

May 28, 2015Estimated

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

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PWD testing POGO® BGMS		All enrolled persons with diabetes	Device: POGO® BGMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
POGO® BGMS	Device	SMBG	PWD testing POGO® BGMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diablo Clinical Reasearch		Walnut Creek	California	94598	United States
Park Nicollett Institute - International Diabetes Center

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