Threshold Suspend in Pediatrics at Home
- Conditions
- Type 1 Diabetes
- Interventions
- Device: 530G Insulin pump
- Registration Number
- NCT02120794
- Lead Sponsor
- Medtronic Diabetes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 194
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 530G insulin pump 530G Insulin pump Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
- Primary Outcome Measures
Name Time Method Overall Mean Change in A1C Baseline and 1 year after screening The overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.
- Secondary Outcome Measures
Name Time Method Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups Baseline and 1 year after screening Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c \> 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c \> 9%
Trial Locations
- Locations (16)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
SoCal Diabetes
🇺🇸Torrance, California, United States
Madison Clinic for Pediatric Diabetes at UCSF
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Nemours Children's Health System
🇺🇸Jacksonville, Florida, United States
Children's Hospital and Clinics of Minnesota
🇺🇸Saint Paul, Minnesota, United States
University of Colorado Health Science Center, Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, United States
The Pediatric and Endocrine Diabetes Specialists
🇺🇸Las Vegas, Nevada, United States
Texas Children Hospital/Baylor College of Medicine
🇺🇸Houston, Texas, United States
Sutter Institute for Medical Research Excellence in Diabetes and Endocrinology
🇺🇸Sacramento, California, United States
Park Nicollet Clinic - International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Stony Brook Children's Hospital
🇺🇸East Setauket, New York, United States
University of Minnesota Pediatric Endocrinology Clinic
🇺🇸Minneapolis, Minnesota, United States