Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

Status unconfirmed

Conditions studied: Type 1 Diabetes, Type 2 Diabetes, Gestational Diabetes

In brief

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.

Key facts

Study ID

NCT01415544

Run by

InLight Solutions

People needed

100

Starts

2011-06-01

Expected to finish

2012-02-01

Last updated by the study team

2012-02-27

Who can join

Age: 20 and older, up to 50. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Lovelace Scientific Resources — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.