Status:
UNKNOWN
Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
Lead Sponsor:
InLight Solutions
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
FEMALE
20-50 years
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...
Detailed Description
Currently, individuals with diabetes must use an invasive finger stick methodology for the determination of their blood glucose levels. Although current technology glucose meters use a smaller amount ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01415544
Start Date
June 1 2011
End Date
February 1 2012
Last Update
February 27 2012
Active Locations (1)
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1
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87106