Threshold Suspend in Pediatrics at Home



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:2 - 15
Updated:9/13/2018
Start Date:June 2014
End Date:June 16, 2017

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Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes

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.

This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend
(TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1
diabetes. The study will measure the change in A1C from baseline over a period of one year
while subjects are wearing the study pump.

Inclusion Criteria:

1. Subject is age 2 to 15 at time of screening

2. Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed
for at least one year prior to screening

3. Subject is currently transitioning from pump therapy, with or without continued
glucose monitoring (CGM), to the 530G insulin pump system.

4. Subject is willing to perform greater than or equal to 4 finger stick blood glucose
measurements daily

5. Subject is willing to perform required sensor calibrations

6. Subject is willing to wear the system (Pump, glucose sensors, meter) continuously
throughout the study

7. Subject is willing to upload data every 21 days from the study pump

8. 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.

9. Subject is using either Humalog or Novolog at time of Screening and plans to use
either of those insulins throughout the study

Exclusion Criteria:

1. 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.

2. Women of child-bearing potential who have a positive pregnancy test at screening or
plan 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 is using pramlintide (Symlin) at time of screening

11. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell
transfusion or erythropoietin within 3 months prior to time of screening

12. Subject plans to receive red blood cell transfusion or erythropoietin over the course
of study participation

13. Subject diagnosed with current eating disorder such as anorexia or bulimia

14. Subject has been diagnosed with chronic kidney disease that results in chronic anemia

15. Subject is on dialysis

16. Subject is already on a 530G system with CGM for 8 days or more.
We found this trial at
16
sites
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Aurora, CO
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East Setauket, New York 11733
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Houston, TX
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Jacksonville, Florida 32207
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Las Vegas, NV
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Minneapolis, MN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Sacramento, CA
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310 Smith Avenue North
Saint Paul, Minnesota 55102
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Saint Paul, MN
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San Francisco, California 94158
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Torrance, California 90505
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Torrance, CA
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