Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data

Exclusion Criteria

• •1. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks.
• •2. Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study
• •3. Subject is being treated for hyperthyroidism at time of screening
• •4. Subject has an abnormality (\>1.8mg/dL) in creatinine at time of screening visit
• •5. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. If TSH is out of range, Free T3 and Free T4 will be tested. Subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range.
• •6. Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
• •7. Subject is currently abusing illicit drugs
• •8. Subject is currently abusing prescription drugs
• •9. Subject is currently abusing alcohol
• •10. Subject has sickle cell disease or hemoglobinopathy
• •11. Subject has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation
• •12. Subject diagnosed with current eating disorder such as anorexia or bulimia
• •13. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
• •14. Subject is on dialysis