Study Results
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View full resultsBasic Information
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COMPLETED
NA
194 participants
INTERVENTIONAL
2014-06-30
2017-06-16
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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530G insulin pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Interventions
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530G Insulin pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Eligibility Criteria
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Inclusion Criteria
2. Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed for at least one year prior to screening
3. Subject is currently transitioning from pump therapy, with or without continued glucose monitoring (CGM), to the 530G insulin pump system.
4. Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
5. Subject is willing to perform required sensor calibrations
6. Subject is willing to wear the system (Pump, glucose sensors, meter) continuously throughout the study
7. Subject is willing to upload data every 21 days from the study pump
8. 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.
9. Subject is using either Humalog or Novolog at time of Screening and plans to use either of those insulins throughout the study
Exclusion Criteria
2. Women of child-bearing potential who have a positive pregnancy test at screening or plan 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 is using pramlintide (Symlin) at time of screening
11. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
12. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
13. Subject diagnosed with current eating disorder such as anorexia or bulimia
14. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
15. Subject is on dialysis
16. Subject is already on a 530G system with CGM for 8 days or more.
2 Years
15 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, M.D.
Role: STUDY_DIRECTOR
Medtronic Diabetes
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
Sacramento, California, United States
Madison Clinic for Pediatric Diabetes at UCSF
San Francisco, California, United States
Stanford University
Stanford, California, United States
SoCal Diabetes
Torrance, California, United States
University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Nemours Children's Health System
Jacksonville, Florida, United States
Park Nicollet Clinic - International Diabetes Center
Minneapolis, Minnesota, United States
University of Minnesota Pediatric Endocrinology Clinic
Minneapolis, Minnesota, United States
Children's Hospital and Clinics of Minnesota
Saint Paul, Minnesota, United States
The Pediatric and Endocrine Diabetes Specialists
Las Vegas, Nevada, United States
Stony Brook Children's Hospital
East Setauket, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children Hospital/Baylor College of Medicine
Houston, Texas, 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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CEP287
Identifier Type: -
Identifier Source: org_study_id
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