Evaluation and Comparison of Noninvasive Blood Glucose Co... | NCT01745900

Studies
Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

NCT01745900

Sponsor

VeraLight, Inc.

Status

Unknown status

Last Update Posted

Dec 10, 2012Estimated

Enrollment

125Estimated

Phase

Not provided

Conditions

Insulin Dependent Diabetes
Non Insulin Dependent Diabetes
Gestational Diabetes

Interventions

Not provided

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Dec 4, 2012

First Submission Date that Met QC Criteria

Dec 6, 2012

First Posted Date

Dec 10, 2012Estimated

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

Dec 6, 2012

Last Update Posted Date

Dec 10, 2012Estimated

Name	Class
InLight Solutions	INDUSTRY

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

Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.

Detailed Description

The objectives of this study are

collect subject data on a near-infrared spectroscopy-based glucose meter
evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.

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

125Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Continuing validation of near infrared spectroscopy-based glucose meter algorithm		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.

Exclusion Criteria:

Severe heart disease as evidenced by peripheral edema (self reported)
Currently taking Lasix (self reported)
Liver disease as evidenced by jaundice (self reported)
Receiving dialysis or having known renal compromise (self reported)
Skin damage at optical sampling site
Scars, tattoos, rashes or other disruption/discoloration on the right index finger
Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported)
Current chemotherapy, or chemotherapy within the past 12 months (self reported)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Females 18-50 years of age selected from the community 30% with no history of Diabetes 70% with diagnosis of Type I, Type II or Gestational Diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amber Brassfield, RN	Contact	619-291-2845
Amber Brassfield, RN	Contact	619-366-1129

Overall Officials

Name	Affiliation	Role
Amber Brassfield, RN	Accelovance	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Accelovance Inc.	Recruiting	San Diego	California	92108	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2
D016640	Diabetes, Gestational
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