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

Diabetes Clinical Trial

Official title:

Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003898
• Other study ID #: CEP266
• Status: Completed
• Phase: N/A
• Start date: November 26, 2013
• Est. completion date: February 20, 2018

Study information

• Verified date: February 2019
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Medtronic MiniMed 530G Insulin Pump

Locations

Country	Name	City	State
United States	University of Michigan Diabetes Research Center	Ann Arbor	Michigan
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center (1)	Aurora	Colorado
United States	Barbara Davis Center (2)	Aurora	Colorado
United States	AM Diabetes and Endocrinology Center	Bartlett	Tennessee
United States	Southwestern Vermont Health Care	Bennington	Vermont
United States	Billings Clinic	Billings	Montana
United States	Grunberger Diabetes Institute	Bloomfield Hills	Michigan
United States	The University of Chicago	Chicago	Illinois
United States	East Alabama Endocrinology PC	Columbus	Georgia
United States	Iowa Diabetes and Endocrinology Center	Des Moines	Iowa
United States	AMCR Institute	Escondido	California
United States	Valley Research	Fresno	California
United States	Spectrum Health System	Grand Rapids	Michigan
United States	Physicians East, PA	Greenville	North Carolina
United States	East Coast Institute for Research	Jacksonville	Florida
United States	Glacier View Research Institute-Endocrinology	Kalispell	Montana
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	Imperial Health	Lake Charles	Louisiana
United States	Endocrine Associates of Florida, P.A.	Lake Mary	Florida
United States	Complete Endocrinology	Lincoln	Nebraska
United States	Medical Investigations, Inc.	Little Rock	Arkansas
United States	Winthrop University Hospital	Mineola	New York
United States	International Diabetes Center	Minneapolis	Minnesota
United States	TLC Diabetes Healthcare Consultants & Education Inc.	Naples	Florida
United States	The Diabetes Center	Ocean Springs	Mississippi
United States	Oregon Health & Science University	Portland	Oregon
United States	Tri-Cities Diabetes and Endocrinology Center	Richland	Washington
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Center of Excellence in Diabetes & Endocrinology	Sacramento	California
United States	Eastern Shore Diabetes and Endocrinology Center	Salisbury	Maryland
United States	Consano Clinical Research, LLC	San Antonio	Texas
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Northeast Clinical Research of San Antonio, LLC	Schertz	Texas
United States	Joslin Diabetes Center	Syracuse	New York
United States	Pediatric Endocrine Associates	Tampa	Florida
United States	Diabetes, Endocrinology, Metabolism Specialties	Teaneck	New Jersey
United States	Isaiah Pittman IV, MD	Terre Haute	Indiana
United States	So Cal Diabetes	Torrance	California
United States	Good Samaritan Hospital Physician Services	Vincennes	Indiana
United States	University at Buffalo, The State University of New York	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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