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Post Approval Study of the TS (Threshold Suspend) Feature with a Sensor-Augmented Pump System

Description

This Post Approval Study is a longitudinal, multi-center trial. Up to 1,200 subjects will be enrolled in investigational centers across the United States. Subjects will attend 6 study visits over a period of one year. The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration, as measured by change in A1C.

Phase

N/A

Inclusion and Exclusion Criteria

  • Subject is age 16 or older at time of screening
  • Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.
  • Subject is currently on pump therapy.
  • Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.
  • Subject is willing to complete all study related activities
  • Subject is willing to upload data every 21 days from the study pump
  • Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend's computer system with Internet access.
  • Subject is able (by insurance or financial means) to cover the initial investment and ongoing cost of the 530G insulin pump and consumables, CGM, Bayer CONTOUR Next Link RF enabled meter and supplies for the length of the study- 1 year.

  • 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.
  • 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
  • Subject is being treated for hyperthyroidism at time of screening
  • Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
  • 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.
  • 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
  • Subject is currently abusing illicit drugs
  • Subject is currently abusing prescription drugs
  • Subject is currently abusing alcohol
  • Subject has sickle cell disease or hemoglobinopathy
  • 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
  • Subject diagnosed with current eating disorder such as anorexia or bulimia
  • Subject has been diagnosed with chronic kidney disease that results in chronic anemia
  • Subject is on dialysis

Sites

  • California

    • So Cal Diabetes, Torrance, California, 90505
    • AMCR Institute, Escondido, California, 92026
  • Oregon

    • Oregon Health & Science University, Portland, Oregon, 97239
  • Colorado

    • Barbara Davis Center, Aurora, Colorado, 80045
    • Barbara Davis Center, Aurora, Colorado, 80045
  • Washington

    • Tri-Cities Diabetes and Endocrinology Center, Richland, Washington, 99352
  • Oklahoma

    • Pediatric Endocrinology, Genetics & Metabolism, Oklahoma City, Oklahoma, 73112
  • Texas

    • Diabetes and Glandular Disease Clinic, San Antonio, Texas, 78229
    • Consano Clinical Research, LLC, San Antonio, Texas, 78258
    • Northeast Clinical Research of San Antonio, LLC, Schertz, Texas, 78154
    • Endocrine Associates, Houston, Texas, 77004
  • Nebraska

    • Complete Endocrinology, Lincoln, Nebraska, 68506
  • Arkansas

    • Medical Investigations, Inc., Little Rock, Arkansas, 72205
  • Louisiana

    • Imperial Health, Lake Charles, Louisiana, 70601
  • Minnesota

    • International Diabetes Center, Minneapolis, Minnesota, 55416
  • Tennessee

    • AM Diabetes and Endocrinology Center, Bartlett, Tennessee, 38133
    • University Diabetes and Endocrine Consultants, Chattanooga, Tennessee, 37411
  • Indiana

    • Good Samaritan Hospital Physician Services, Vincennes, Indiana, 47591
    • Isaiah Pittman IV, MD, Terre Haute, Indiana, 47802
  • Georgia

    • East Alabama Endocrinology PC, Columbus, Georgia, 31907
    • Atlanta Diabetes Associates, Atlanta, Georgia, 30318
    • Pediatric Endocrine Associates, P.C., Atlanta, Georgia, 30342
    • Endocrine Research Solutions, Roswell, Georgia, 30076
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