Medtronic Threshold Suspend for Children & Adolescents with Type 1 Diabetes
The Medtronic TS trial is investigating the safety and efficacy of the Threshold Suspend feature in the sensor augmented 530g insulin pump. The feature is designed to enhance the ability to manage glucose levels in children and adolescents with type 1 diabetes.
Study sponsors
Medtronic Inc.
Principal Investigator
Steven Willi, MD, Director of the Diabetes Center at CHOP
Who can participate?
- Children and adolescents between 2 and 15 years old
- Diagnosed with type 1 diabetes at least one year
- Transitioning to the Medtronic 530g pump system and/or upgrading to sensor augmented therapy
What is this study about?
The study will compare HbA1C levels measured over regular intervals to assess the benefits and risks of the sensor augmented insulin pump with threshold suspend feature for use in children and adolescents. Data will be collected and analyzed over the 12 months of continuous device wear to ensure that the use of the device and the Threshold Suspend feature are safe and effective.
What does participation involve?
If you want to see if you qualify for this study, you will be scheduled for a screening visit at the CHOP research clinic where you can expect:
- Interviews about your medical history
- Physical examination
- Blood and urine samples collected for testing
Eligible volunteers that consent to participate will be enrolled for one (1) year.
A few things you should know about participating in the Medtronic study:
- Participation is voluntary and you may quit the study at any time, for any reason
- Participants must be willing and able to:
- Wear the device system for the whole year
- Upload pump data from their home and
- Maintain a diabetes diary for the whole year
- Cover the initial investment and ongoing cost of the study pump and consumables for 1 year
- are using and plan to continue using Novolog or Humolog insulin.
How long will this study last?
Participation will last one year.
Reimbursement
Participants will be compensated for travel expenses, time and effort.
For more information
http://clinicaltrials.gov/ct2/show/NCT02120794?term=medtronic+threshold+...
If interested
Please email diabetesresearch@email.chop.edu or call 267-426-7519
CHOP IRB#:
Effective Date: June 2014
Expiration Date: May 2016
