Clinical trial NCT02003898: Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data
Official title: Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Insulin pump
Threshold Suspend
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 372
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects are assigned to treatment with the Medtronic 530G Insulin Pump
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in A1C From Baseline to 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%
timeFrame: 1 year
measure: Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%
timeFrame: 1 year
measure: Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%
timeFrame: 1 year
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Medical Investigations, Inc.
state: Arkansas
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Sacramento
country: United States
facility: Center of Excellence in Diabetes & Endocrinology
state: California
city: Torrance
country: United States
facility: So Cal Diabetes
state: California
city: Aurora
country: United States
facility: Barbara Davis Center (1)
state: Colorado
city: Aurora
country: United States
facility: Barbara Davis Center (2)
state: Colorado
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Lake Mary
country: United States
facility: Endocrine Associates of Florida, P.A.
state: Florida
city: Naples
country: United States
facility: TLC Diabetes Healthcare Consultants & Education Inc.
state: Florida
city: Tampa
country: United States
facility: Pediatric Endocrine Associates
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Columbus
country: United States
facility: East Alabama Endocrinology PC
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Terre Haute
country: United States
facility: Isaiah Pittman IV, MD
state: Indiana
city: Vincennes
country: United States
facility: Good Samaritan Hospital Physician Services
state: Indiana
city: Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Center
state: Iowa
city: Lake Charles
country: United States
facility: Imperial Health
state: Louisiana
city: Salisbury
country: United States
facility: Eastern Shore Diabetes and Endocrinology Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Diabetes Research Center
state: Michigan
city: Bloomfield Hills
country: United States
facility: Grunberger Diabetes Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Ocean Springs
country: United States
facility: The Diabetes Center
state: Mississippi
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Kalispell
country: United States
facility: Glacier View Research Institute-Endocrinology
state: Montana
city: Lincoln
country: United States
facility: Complete Endocrinology
state: Nebraska
city: Teaneck
country: United States
facility: Diabetes, Endocrinology, Metabolism Specialties
state: New Jersey
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Syracuse
country: United States
facility: Joslin Diabetes Center
state: New York
city: Williamsville
country: United States
facility: University at Buffalo, The State University of New York
state: New York
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research of San Antonio, LLC
state: Texas
city: Bennington
country: United States
facility: Southwestern Vermont Health Care
state: Vermont
city: Richland
country: United States
facility: Tri-Cities Diabetes and Endocrinology Center
state: Washington
Study officials:
affiliation: Medtronic Diabetes
name: Scott Lee, MD
role: STUDY_DIRECTOR
References: