Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data
- Conditions
- Diabetes
- Interventions
- Device: Medtronic MiniMed 530G Insulin Pump
- Registration Number
- NCT02003898
- Lead Sponsor
- Medtronic Diabetes
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medtronic MiniMed 530G Insulin Pump Medtronic MiniMed 530G Insulin Pump All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
- Primary Outcome Measures
Name Time Method Mean Change in A1C From Baseline to 1 Year 1 year Comparison of A1C measurement from baseline to end of study in the CEP266 study population.
The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.
- Secondary Outcome Measures
Name Time Method Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9% 1 year Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%
Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9% 1 year Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c \> 9%
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7% 1 year Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.
Trial Locations
- Locations (43)
The Diabetes Center
🇺🇸Ocean Springs, Mississippi, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Diabetes, Endocrinology, Metabolism Specialties
🇺🇸Teaneck, New Jersey, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Southwestern Vermont Health Care
🇺🇸Bennington, Vermont, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Glacier View Research Institute-Endocrinology
🇺🇸Kalispell, Montana, United States
Complete Endocrinology
🇺🇸Lincoln, Nebraska, United States
Joslin Diabetes Center
🇺🇸Syracuse, New York, United States
AM Diabetes and Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Spectrum Health System
🇺🇸Grand Rapids, Michigan, United States
Grunberger Diabetes Institute
🇺🇸Bloomfield Hills, Michigan, United States
University at Buffalo, The State University of New York
🇺🇸Williamsville, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Iowa Diabetes and Endocrinology Center
🇺🇸Des Moines, Iowa, United States
Isaiah Pittman IV, MD
🇺🇸Terre Haute, Indiana, United States
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
East Alabama Endocrinology PC
🇺🇸Columbus, Georgia, United States
Good Samaritan Hospital Physician Services
🇺🇸Vincennes, Indiana, United States
Imperial Health
🇺🇸Lake Charles, Louisiana, United States
University of Michigan Diabetes Research Center
🇺🇸Ann Arbor, Michigan, United States
Endocrine Research Solutions
🇺🇸Roswell, Georgia, United States
Tri-Cities Diabetes and Endocrinology Center
🇺🇸Richland, Washington, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Consano Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
Barbara Davis Center (1)
🇺🇸Aurora, Colorado, United States
Pediatric Endocrine Associates
🇺🇸Tampa, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
AMCR Institute
🇺🇸Escondido, California, United States
Medical Investigations, Inc.
🇺🇸Little Rock, Arkansas, United States
Valley Research
🇺🇸Fresno, California, United States
So Cal Diabetes
🇺🇸Torrance, California, United States
Center of Excellence in Diabetes & Endocrinology
🇺🇸Sacramento, California, 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
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Northeast Clinical Research of San Antonio, LLC
🇺🇸Schertz, Texas, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Eastern Shore Diabetes and Endocrinology Center
🇺🇸Salisbury, Maryland, United States