Threshold Suspend in Pediatrics at Home

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

• 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

Exclusion criteria

• 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.