Reproducibility of HbA1c Measurement on the Aina HbA1c Mo... | NCT03232437

Studies
Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

NCT03232437

Sponsor

Jana Care

Status

Completed

Last Update Posted

Jul 28, 2017Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Aina HbA1c Monitoring System

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

ID	Type	Description	Link
A1C-OCRC-001	Other Identifier	JanaCare
A1C-AM-001	Other Identifier	JanaCare

Status Module

Record Verification Date

Jul 2017

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

Jun 14, 2017Actual

Primary Completion Date

Jun 21, 2017Actual

Completion Date

Jun 21, 2017Actual

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 26, 2017

First Posted Date

Jul 28, 2017Actual

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

Jul 26, 2017

Last Update Posted Date

Jul 28, 2017Actual

Name	Class
The Forsyth Institute	OTHER
Orange County Research Center	OTHER
ActivMed Practices & Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites:

Forsyth Institute in Cambridge, MA
Orange County Research Center in Tustin, CA
ActivMed Practices & Research in Methuen, MA

Detailed Description

Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.

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

Retention

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aina HbA1c Monitoring System	Device	Monitoring test for quantitative determination of HbA1c

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Precision (as measured by %CV) of HbA1c measurements	HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.	Each sample was measured in triplicate, twice per day, over the course of five days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Agree to the terms of this consent form
Sign this consent form
Be 18 years or older
Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15%
Provide blood samples from your arm and finger
Come in in the morning of the study visit

Exclusion Criteria:

Not have a recent history of anemia or hemoglobin concentration above 20%
Not be pregnant
Not have previously given a blood sample to the Study Sponsor for a study

Accepts Healthy Volunteers

Yes

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

Healthy and Diabetic patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hatice Hasturk, PhD	Forsyth Institute	Principal Investigator
Joel Neutel, MD	Orange County Research Center	Principal Investigator
Michael McCartney, MD	ActivMed Practices & Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orange County Research Center		Tustin	California	92780	United States
The Forsyth Institute

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