Clinical trial NCT02120794: Threshold Suspend in Pediatrics at Home
Official title: Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Pediatric
Threshold Suspend
Sensor augmented pump
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 194
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Mean Change in A1C
timeFrame: Baseline and 1 year after screening
Secondary outcomes:
measure: Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
timeFrame: Baseline and 1 year after screening
measure: Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
timeFrame: Baseline and 1 year after screening
measure: Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
timeFrame: Baseline and 1 year after screening
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
state: California
city: San Francisco
country: United States
facility: Madison Clinic for Pediatric Diabetes at UCSF
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: SoCal Diabetes
state: California
city: Aurora
country: United States
facility: University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Jacksonville
country: United States
facility: Nemours Children's Health System
state: Florida
city: Minneapolis
country: United States
facility: Park Nicollet Clinic - International Diabetes Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Pediatric Endocrinology Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospital and Clinics of Minnesota
state: Minnesota
city: Las Vegas
country: United States
facility: The Pediatric and Endocrine Diabetes Specialists
state: Nevada
city: East Setauket
country: United States
facility: Stony Brook Children's Hospital
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children Hospital/Baylor College of Medicine
state: Texas
Study officials:
affiliation: Medtronic Diabetes
name: Scott Lee, M.D.
role: STUDY_DIRECTOR
References: