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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Medtronic MiniMed 530G Insulin Pump

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.

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Medical Investigations, Inc.
  • California
    • Escondido, California, United States, 92026
      • AMCR Institute
    • Fresno, California, United States, 93720
      • Valley Research
    • Sacramento, California, United States, 98521
      • Center of Excellence in Diabetes & Endocrinology
    • Torrance, California, United States, 90505
      • So Cal Diabetes
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center (1)
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center (2)
  • Florida
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research
    • Lake Mary, Florida, United States, 32746
      • Endocrine Associates of Florida, P.A.
    • Naples, Florida, United States, 34109
      • TLC Diabetes Healthcare Consultants & Education Inc.
    • Tampa, Florida, United States, 33607
      • Pediatric Endocrine Associates
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Columbus, Georgia, United States, 31907
      • East Alabama Endocrinology PC
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Isaiah Pittman IV, MD
    • Vincennes, Indiana, United States, 47591
      • Good Samaritan Hospital Physician Services
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Diabetes and Endocrinology Center
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Imperial Health
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Eastern Shore Diabetes and Endocrinology Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Diabetes Research Center
    • Bloomfield Hills, Michigan, United States, 48302
      • Grunberger Diabetes Institute
    • Grand Rapids, Michigan, United States, 49546
      • Spectrum Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • The Diabetes Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • The Children's Mercy Hospital
  • Montana
    • Billings, Montana, United States, 59107
      • Billings Clinic
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute-Endocrinology
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Complete Endocrinology
  • New Jersey
    • Teaneck, New Jersey, United States, 07666-3445
      • Diabetes, Endocrinology, Metabolism Specialties
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Syracuse, New York, United States, 13210
      • Joslin Diabetes Center
    • Williamsville, New York, United States, 14221
      • University at Buffalo, The State University of New York
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East, PA
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes And Endocrinology Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials
    • San Antonio, Texas, United States, 78258
      • Consano Clinical Research, LLC
    • Schertz, Texas, United States, 78154
      • Northeast Clinical Research of San Antonio, LLC
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Southwestern Vermont Health Care
  • Washington
    • Richland, Washington, United States, 99352
      • Tri-Cities Diabetes and Endocrinology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medtronic MiniMed 530G Insulin Pump; All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.	Device: Medtronic MiniMed 530G Insulin Pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in A1C From Baseline to 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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%	Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.	1 year
Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%	Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%	1 year
Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%	Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c > 9%	1 year

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Study Director: Scott Lee, MD, Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2013
• Primary Completion (Actual): February 20, 2018
• Study Completion (Actual): February 20, 2018

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; Insulin pump; Threshold Suspend
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: CEP266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No