Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome) (NCT03815487) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)
Germany40 participantsStarted 2018-11-19
Plain-language summary
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. This Hybrid closed loop (HCL) system provides several additional effects compared to SAP therapy: according to actual and predicted sensor glucose values, the insulin therapy can be adopted automatically by pump: in case of high values (or predicted) more insulin will be administered, in case of low values (or predicted) the insulin infusion will be decreased a suspended and resumed again. So the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.
The aim of the current trial is to compare the SAP-therapy with the hybrid closed loop glucose management in patients with type 1 diabetes at home.
Who can participate
Age range2 Years – 14 Years
SexALL
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Inclusion criteria
✓. At time of screening: Subjects who are 2-14 years are determined by the investigator to be psychologically sound (e.g. no depression, anxiety disorder, traumatic stress disorder) in order to successfully participate in this study
✓. Subject has been diagnosed with type 1 diabetes ≥ 1 year Study-specific inclusion criteria
✓. Subjects who are 2-14 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
✓. Subject is willing to wear the system continuously throughout the study
✓. Subject is willing to perform required sensor calibrations
✓. Total daily dose of Insulin \>8 U
✓. Subject has an A1C value \< 12.0% (as processed by Laboratory) at time of screening visit
✓. Subject must be on Pump therapy for \>3 months prior to Screening
. Event of severe hypoglycemia in past 3 months (as per ISPAD Guideline Definition 2014: seizure or loss of consciousness.)
✕. Subject is unable to tolerate tape adhesive in the area of sensor placement
✕. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
✕. 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 has had any of the following new diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
✕. Subject has a clinical significant abnormality (out of reference range, as processed by Laboratory) in thyroid-stimulating hormone (TSH) at time of screening visit
✕. Subjects suffering from Morbus Addison, heart failure \>NYHA II, chronic pulmonal disease \>GOLD II, chronic arterial insuffiency, known cancer disease, diabetic kidney disease, diabetic autonom or peropheral neuropathy