Threshold Suspend in Pediatrics at Home

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C.

Key facts

Study ID: NCT02120794
Run by: Medtronic MiniMed, Inc.
People needed: 194
Starts: 2014-06-01
Expected to finish: 2017-06-16
Last updated by the study team: 2018-09-11

Who can join

Age: 2 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is age 2 to 15 at time of screening
Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed for at least one year prior to screening
Subject is currently transitioning from pump therapy, with or without continued glucose monitoring (CGM), to the 530G insulin pump system.
Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
Subject is willing to perform required sensor calibrations
Subject is willing to wear the system (Pump, glucose sensors, meter) continuously throughout the study
Subject is willing to upload data every 21 days from the study pump
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.
Subject is using either Humalog or Novolog at time of Screening and plans to use either of those insulins throughout the study

You may not qualify if…

Subject is actively participating in an investigational study (drug or device) wherein he/she is receiving treatment from an investigational study drug or investigational study device.
Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
Subject is being treated for hyperthyroidism at time of screening
Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
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.
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
Subject is currently abusing illicit drugs
Subject is currently abusing prescription drugs
Subject is currently abusing alcohol
Subject is using pramlintide (Symlin) at time of screening
Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
Subject diagnosed with current eating disorder such as anorexia or bulimia
Subject has been diagnosed with chronic kidney disease that results in chronic anemia
Subject is on dialysis
Subject is already on a 530G system with CGM for 8 days or more.

Where it is running

Children's Hospital Los Angeles — Los Angeles, California, United States
Children's Hospital of Orange County — Orange, California, United States
Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology — Sacramento, California, United States
Madison Clinic for Pediatric Diabetes at UCSF — San Francisco, California, United States
Stanford University — Stanford, California, United States
SoCal Diabetes — Torrance, California, United States
University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
Yale University School of Medicine — New Haven, Connecticut, United States
Nemours Children's Health System — Jacksonville, Florida, United States
Park Nicollet Clinic - International Diabetes Center — Minneapolis, Minnesota, United States
University of Minnesota Pediatric Endocrinology Clinic — Minneapolis, Minnesota, United States
Children's Hospital and Clinics of Minnesota — Saint Paul, Minnesota, United States
The Pediatric and Endocrine Diabetes Specialists — Las Vegas, Nevada, United States
Stony Brook Children's Hospital — East Setauket, New York, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Texas Children Hospital/Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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