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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:16 - Any
Updated:3/7/2019
Start Date:November 26, 2013
End Date:February 20, 2018

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Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data

The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic
MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.

Multi-center trial is initiated to observe the Threshold Suspend (TS) feature with a
sensor-augmented insulin pump (Medtronic MiniMed® 530G insulin pump) in patients 16 and older
with insulin requiring diabetes over a period of one year.

Inclusion Criteria:

1. Subject is age 16 or older at time of screening

2. Subject has been diagnosed with diabetes mellitus for at least one year prior to
screening.

3. Subject is currently on pump therapy.

4. Subject is transitioning to the 530G insulin pump system with the TS feature turned
ON.

5. Subject is willing to complete all study related activities

6. Subject is willing to upload data every 21 days from the study pump

7. 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.

8. 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.

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
We found this trial at
43
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Andrew Ahmann, MD
Phone: 503-494-4392
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Louis L. Philipson, MD
Phone: 773-702-9180
University of Chicago One of the world's premier academic and research institutions, the University of...
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Principal Investigator: John Evans, MD
Phone: 904-384-2240
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Jacksonville, FL
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Mark Clements, MD
Phone: 816-950-8940
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
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Ann Arbor, Michigan 48105
Principal Investigator: Rodica Pop-Busui, MD
Phone: 734-936-8065
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Atlanta, Georgia 30309
Principal Investigator: Bruce Bode, MD
Phone: 404-355-4393
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1775 Aurora Court
Aurora, Colorado 80045
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1775 Aurora Court
Aurora, Colorado 80045
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Bartlett, Tennessee 38133
Principal Investigator: Kashif Latif, MD
Phone: 901-581-1587
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Bennington, Vermont 05201
Principal Investigator: David Gorson, MD
Phone: 802-442-3022
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Principal Investigator: Jeanne Perelez-Ortiz, MD
Phone: 406-435-5667
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Bloomfield Hills, Michigan 48302
Principal Investigator: George Grunberger, MD
Phone: 248-335-7740
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Columbus, Georgia 31907
Principal Investigator: Bantwa Baliga, MD
Phone: 727-612-6511
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Des Moines, Iowa 50314
Principal Investigator: Anuj Bhargava, MD
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Escondido, California 92026
Principal Investigator: Timothy Bailey, MD
Phone: 760-466-1523
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Fresno, California 93720
Principal Investigator: Paul Norwood, MD
Phone: 559-261-0992
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Grand Rapids, Michigan 49503
Principal Investigator: Gregory Deines, DO
Phone: 616-486-2054
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Greenville, North Carolina 27834
Principal Investigator: Mark Warren, MD
Phone: 252-916-4356
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Kalispell, Montana 59901
Principal Investigator: Jose de Souza, MD
Phone: 406-751-4171
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Lake Charles, Louisiana 70601
Principal Investigator: Timothy Gilbert, MD
Phone: 337-312-8405
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Lake Mary, Florida 32746
Principal Investigator: Victor Roberts, MD
Phone: 407-936-3860
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Lincoln, Nebraska 68506
Principal Investigator: Shannon Wakeley, MD
Phone: 402-405-0500
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Little Rock, Arkansas 72205
Principal Investigator: James Thrasher, MD
Phone: 501-666-3666
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Siham Accacha, MD
Phone: 516-663-2112
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Minneapolis, Minnesota 55416
Principal Investigator: Richard Bergenstal, MD
Phone: 952-993-3640
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Naples, Florida 34109
Principal Investigator: Vita Anksh, MD
Phone: 239-254-1316
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Ocean Springs, Mississippi 39564
Principal Investigator: Kathleen Arnold, ACNP-BC, BC-ADM
Phone: (228) 875-3606
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Richland, Washington 99352
Principal Investigator: Bruce Wilson, MD
Phone: 509-943-4500
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Rochester, Minnesota 55905
Principal Investigator: Yogish Kudva, MD
Phone: 507-255-5916
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Rochester, New York 14621
Principal Investigator: Seth Charatz, MD
Phone: 585-922-8060
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Roswell, Georgia 30076
Principal Investigator: John Reed, MD
Phone: 678-904-5259
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Sacramento, California 98521
Principal Investigator: Gnanagurudusan Prakasam, MD
Phone: 916-426-1902
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Salisbury, Maryland 21804
Principal Investigator: Jack Snitzer, MD
Phone: 410-543-7019
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San Antonio, Texas 78258
Principal Investigator: Michelle Welch, MD
Phone: 210-545-4900
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Schertz, Texas 78154
Principal Investigator: Laura Akright, MD
Phone: 210-771-5110
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Syracuse, New York 13210
Principal Investigator: Ruth Weinstock, MD
Phone: 315-464-9006
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Tampa, Florida 33607
Principal Investigator: Terry DeClue, MD
Phone: 813-870-4432
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Teaneck, New Jersey 07666
Principal Investigator: Michael Magnotti, MD
Phone: 201-836-5655
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Terre Haute, Indiana 47802
Principal Investigator: Isaiah Pittman, MD
Phone: 812-235-8496
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Torrance, California 90505
Principal Investigator: Kevin Kaiserman, MD
Phone: 310-962-1808
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Vincennes, Indiana 47591
Principal Investigator: Jane Bridges, MD
Phone: 812-885-8013
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Williamsville, New York 14221
Principal Investigator: Nitesh Kyhadiya, MD
Phone: 716-626-7988
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