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

Completed · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID: NCT02003898
Run by: Medtronic MiniMed, Inc.
People needed: 372
Starts: 2013-11-26
Expected to finish: 2018-02-20
Last updated by the study team: 2019-03-05

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Medical Investigations, Inc. — Little Rock, Arkansas, United States
AMCR Institute — Escondido, California, United States
Valley Research — Fresno, California, United States
Center of Excellence in Diabetes & Endocrinology — Sacramento, California, United States
So Cal Diabetes — Torrance, California, United States
Barbara Davis Center (1) — Aurora, Colorado, United States
Barbara Davis Center (2) — Aurora, Colorado, United States
East Coast Institute for Research — Jacksonville, Florida, United States
Endocrine Associates of Florida, P.A. — Lake Mary, Florida, United States
TLC Diabetes Healthcare Consultants & Education Inc. — Naples, Florida, United States
Pediatric Endocrine Associates — Tampa, Florida, United States
Atlanta Diabetes Associates — Atlanta, Georgia, United States
East Alabama Endocrinology PC — Columbus, Georgia, United States
Endocrine Research Solutions — Roswell, Georgia, United States
The University of Chicago — Chicago, Illinois, United States
Isaiah Pittman IV, MD — Terre Haute, Indiana, United States
Good Samaritan Hospital Physician Services — Vincennes, Indiana, United States
Iowa Diabetes and Endocrinology Center — Des Moines, Iowa, United States
Imperial Health — Lake Charles, Louisiana, United States
Eastern Shore Diabetes and Endocrinology Center — Salisbury, Maryland, United States
University of Michigan Diabetes Research Center — Ann Arbor, Michigan, United States
Grunberger Diabetes Institute — Bloomfield Hills, Michigan, United States
Spectrum Health System — Grand Rapids, Michigan, United States
International Diabetes Center — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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