Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data
NCT ID: NCT02003898
Last Updated: 2019-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
372 participants
INTERVENTIONAL
2013-11-26
2018-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Medtronic MiniMed 530G Insulin Pump
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump
Interventions
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Medtronic MiniMed 530G Insulin Pump
Eligibility Criteria
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Inclusion Criteria
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
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
16 Years
ALL
No
Sponsors
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Medtronic Diabetes
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Lee, MD
Role: STUDY_DIRECTOR
Medtronic Diabetes
Locations
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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
The Diabetes Center
Ocean Springs, Mississippi, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Billings Clinic
Billings, Montana, United States
Glacier View Research Institute-Endocrinology
Kalispell, Montana, United States
Complete Endocrinology
Lincoln, Nebraska, United States
Diabetes, Endocrinology, Metabolism Specialties
Teaneck, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Rochester General Hospital
Rochester, New York, United States
Joslin Diabetes Center
Syracuse, New York, United States
University at Buffalo, The State University of New York
Williamsville, New York, United States
Physicians East, PA
Greenville, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Consano Clinical Research, LLC
San Antonio, Texas, United States
Northeast Clinical Research of San Antonio, LLC
Schertz, Texas, United States
Southwestern Vermont Health Care
Bennington, Vermont, United States
Tri-Cities Diabetes and Endocrinology Center
Richland, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CEP266
Identifier Type: -
Identifier Source: org_study_id
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