NCT01745900

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

December 4, 2012

Last Update Submit

December 6, 2012

Conditions

Insulin Dependent DiabetesNon Insulin Dependent DiabetesGestational Diabetes

Keywords

DiabetesGestational DiabetesFemale

Outcome Measures

Primary Outcomes (1)

  • Continuing validation of near infrared spectroscopy-based glucose meter algorithm

    3 months

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accelovance Inc.

San Diego, California, 92108, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes, GestationalDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Amber Brassfield, RN

    Accelovance

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber Brassfield, RN

CONTACT

619-291-2845

Amber Brassfield, RN

CONTACT

619-366-1129

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 10, 2012

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

US(1)