Threshold Suspend in Pediatrics at Home

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: 530G Insulin pump


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 530G insulin pump<br>Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year. | Device: 530G Insulin pump<br>* Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mean Change in A1C | 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. | Baseline and 1 year after screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups | Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7% | Baseline and 1 year after screening | 
| Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups | Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9% | Baseline and 1 year after screening | 
| Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups | 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% | Baseline and 1 year after screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Pediatric, Threshold Suspend, Sensor augmented pump