Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based method for measuring glucose concentration relative to invasive blood reference measurements. The initial phase of the study will be focused on procurement of the data needed to develop a robust, accurate calibration. The second phase will be focused on performance evaluation of the system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 27, 2012
February 1, 2012
8 months
August 9, 2011
February 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calibrate near-infrared spectroscopy-based glucose meter
The collection of capillary blood glucose and noninvasive data will allow the calibration of the noninvasive systems and subsequently evaluate performance via a validation study. The paired NIR spectrum and blood reference data acquired during calibration will be processed using multivariate regression techniques to create a calibration model. Results will be compared using a Clark error grid.
1 year
Secondary Outcomes (1)
Compare Noninvasive to invasive techniques
1 year
Study Arms (4)
Type 2 Diabetes
Those previously diagnosed with type 2 diabetes
Type 1 Diabetes
Those previously diagnosed with type 1 diabetes
Gestational Diabetes
Those that are currently diagnosed with gestational diabetes
Healthy Human Volunteers
Those that have not been diagnosed with any type of diabetes
Eligibility Criteria
The Human Subject population consists of female subjects between the ages of 20 and 50. Subjects must have been diagnosed with either Type I, Type II, or Gestational diabetes and may utilize healthy individuals for the validation phase. Up to 100 subjects may be recruited to participate in this study. Subjects will be recruited from the community and will be selected to ensure a representative sample of the projected intended use population. Efforts will also be made to ensure a broad and even distribution of ages (between 20 and 50 years old) and ethnicities.
You may qualify if:
- Female at least 20 years of age but not older than 50 years of age
- Female with Type I or Gestational diabetes based on ADA criteria
- Female with Type II diabetes and A1c of greater than 7.0 as measured on a Bayer A1C Now meter
- May include female healthy volunteers.
You may not qualify if:
- Subject requires hemo-dialysis
- Severe heart disease as evidenced by peripheral edema
- Liver disease as evidenced by jaundice
- Active alcohol or drug abuse
- Body Mass Index (BMI) \> 35 kg/m2
- Hand size too large to fit in the optical measurement instrumentation
- Middle finger width of less than 5 mm
- Skin damage at optical sampling site on hand
- Currently taking prednisone or other systemic steroids
- Tattoo at the optical sampling site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lovelace Scientific Resources
Albuquerque, New Mexico, 87106, United States
Biospecimen
capillary glucose measurements
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Forman, MD
Lovelace Scientific Resources
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 12, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 27, 2012
Record last verified: 2012-02