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

NCT02003898 | Completed Results FDA Device

• 1 other identifier: CEP266
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 43

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.

Conditions

Diabetes

Keywords

Diabetes; Insulin pump; Threshold Suspend

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%

  1 year

• 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, Baseline A1c > 9%

  1 year

Study Arms (1)

Medtronic MiniMed 530G Insulin Pump

EXPERIMENTAL

All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.

Device: Medtronic MiniMed 530G Insulin Pump

Interventions

Medtronic MiniMed 530G Insulin Pump DEVICE

Medtronic MiniMed 530G Insulin Pump

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (43)

Medical Investigations, Inc.

Little Rock, Arkansas, 72205, United States

Location

AMCR Institute

Escondido, California, 92026, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Center of Excellence in Diabetes & Endocrinology

Sacramento, California, 98521, United States

Location

So Cal Diabetes

Torrance, California, 90505, United States

Location

Barbara Davis Center (1)

Aurora, Colorado, 80045, United States

Location

Barbara Davis Center (2)

Aurora, Colorado, 80045, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32204, United States

Location

Endocrine Associates of Florida, P.A.

Lake Mary, Florida, 32746, United States

Location

TLC Diabetes Healthcare Consultants & Education Inc.

Naples, Florida, 34109, United States

Location

Pediatric Endocrine Associates

Tampa, Florida, 33607, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

East Alabama Endocrinology PC

Columbus, Georgia, 31907, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Isaiah Pittman IV, MD

Terre Haute, Indiana, 47802, United States

Location

Good Samaritan Hospital Physician Services

Vincennes, Indiana, 47591, United States

Location

Iowa Diabetes and Endocrinology Center

Des Moines, Iowa, 50314, United States

Location

Imperial Health

Lake Charles, Louisiana, 70601, United States

Location

Eastern Shore Diabetes and Endocrinology Center

Salisbury, Maryland, 21804, United States

Location

University of Michigan Diabetes Research Center

Ann Arbor, Michigan, 48105, United States

Location

Grunberger Diabetes Institute

Bloomfield Hills, Michigan, 48302, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49546, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

The Diabetes Center

Ocean Springs, Mississippi, 39564, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64111, United States

Location

Billings Clinic

Billings, Montana, 59107, United States

Location

Glacier View Research Institute-Endocrinology

Kalispell, Montana, 59901, United States

Location

Complete Endocrinology

Lincoln, Nebraska, 68506, United States

Location

Diabetes, Endocrinology, Metabolism Specialties

Teaneck, New Jersey, 07666-3445, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Joslin Diabetes Center

Syracuse, New York, 13210, United States

Location

University at Buffalo, The State University of New York

Williamsville, New York, 14221, United States

Location

Physicians East, PA

Greenville, North Carolina, 27834, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

AM Diabetes and Endocrinology Center

Bartlett, Tennessee, 38133, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Consano Clinical Research, LLC

San Antonio, Texas, 78258, United States

Location

Northeast Clinical Research of San Antonio, LLC

Schertz, Texas, 78154, United States

Location

Southwestern Vermont Health Care

Bennington, Vermont, 05201, United States

Location

Tri-Cities Diabetes and Endocrinology Center

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Suiying Huang, Statistician
• Organization: Medtronic Minimed

suiying.huang@medtronic.com

818-576-3319

Study Officials

• Scott Lee, MD

  Medtronic Diabetes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects are assigned to treatment with the Medtronic 530G Insulin Pump

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 6, 2013
• Study Start: November 26, 2013
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (43)