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Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data | Clinical Trials | Clareo Health

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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

NCT02003898•Medtronic Diabetes

View on ClinicalTrials.gov

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

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (43)

Medical Investigations, Inc.

Little Rock, Arkansas, United States

AMCR Institute

Escondido, California, United States

Valley Research

Fresno, California, United States

Center of Excellence in Diabetes & Endocrinology

Sacramento, California, United States

So Cal Diabetes

Torrance, California, United States

Barbara Davis Center (1)

Aurora, Colorado, United States

Barbara Davis Center (2)

Aurora, Colorado, United States

East Coast Institute for Research

Jacksonville, Florida, United States

Endocrine Associates of Florida, P.A.

Lake Mary, Florida, United States

TLC Diabetes Healthcare Consultants & Education Inc.

Naples, Florida, United States

Key Dates

Start Date

November 26, 2013

Primary Completion Date

February 20, 2018

Completion Date

February 20, 2018

Last Updated

March 5, 2019

Enrollment

372

ACTUAL participants

Conditions

Diabetes

Interventions

Medtronic MiniMed 530G Insulin Pump

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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