Lay-user Trial of the iGlucose Blood Glucose Monitoring S... | NCT02709707

Studies
Lay-user Trial of the iGlucose Blood Glucose Monitoring System

NCT02709707

Sponsor

Nina Peled

Status

Completed

Last Update Posted

Jun 21, 2016Estimated

Enrollment

153Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Blood glucose monitor

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 2016

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

Mar 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Mar 8, 2016

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 16, 2016Estimated

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 19, 2016

Last Update Posted Date

Jun 21, 2016Estimated

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

Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users

Detailed Description

A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.

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

153Actual

Label	Type	Description	Intervention Names
Patients with diabetes			Device: Blood glucose monitor

Name	Type	Description	Arm Group Labels	Other Names
Blood glucose monitor	Device		Patients with diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of blood glucose measurements as performed by lay users		10 minutes to produce self blood result and to perform lab comparative method

Secondary Outcomes

Measure	Description	Time Frame
Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System		2 -3 hours of going through a self-training session and producing an assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be 12 years of age and older
Have pre-existing diagnosis of diabetes
Be able to read and understand English
Agree to participate in the study
Be able and willing to provide informed consent

Exclusion Criteria:

Do not meet Inclusion Criteria
With Hemophilia or any other bleeding disorder
With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
With physical condition/limitation preventing the use of SMBG on their own

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with a diagnosis of diabetes, either type 1 or type 2, of various duration with blood glucose levels covering the entire measurement range. .

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 Research		Walnut Creek	California	94598	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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