The Multi-Sensor Distance Accuracy Study

Exclusion Criteria

• •1. Pregnancy or Lactation: for women of childbearing potential there is a requirement for a negative urine pregnancy test.
• •2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less the 3.3 g/dL; or serum bilirubin of over 2.
• •3. Hematocrit of less than or equal to 34%.
• •4. Congestive heart failure, NYHA class III or IV.
• •5. Visual impairment preventing reading of glucose meter values.
• •6. Active coronary artery disease as manifested by unstable angina, or a myocardial infarction or therapeutic coronary percutaneous procedure (e.g., PTCA, stent placement) or CABG within the past 4 months.
• •7. Active foot ulceration.
• •8. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• •9. Cerebrovascular accident within the past 6 months.
• •10. Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
• •11. Active malignancy, except basal cell or squamous cell skin cancers.
• •12. Major surgical operation within 30 days prior to screening.
• •13. Seizure disorder (epilepsy).
• •14. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
• •15. Currently administration of oral or parenteral corticosteroids.
• •16. Use of an investigational drug within 30 days prior to screening.
• •17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.