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

February 11, 2019 updated by: Medtronic Diabetes

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
372

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in A1C From Baseline to 1 Year
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%
Time Frame: 1 year
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%
Time Frame: 1 year
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%
Time Frame: 1 year
Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c > 9%
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Diabetes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Scott Lee, MD, Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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