Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)
Condition: Patient Care; Drug Therapy
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Detailed description: 
      Monocentric, randomized, controlled cross-over safety evaluation study. For the study, 20
      subjects per age group (small children 2-<9 years, children/adolescents ≥9-14 years) will be
      enrolled (total n=40). The study is anticipated to last no longer than 6 months from
      investigational center initiation to completion of all data entry and monitoring procedures.
      It is estimated that all subjects will be enrolled into the study within approximately 3
      months of study start.

        -  Visit 1 - Day 0: (Subjects come to clinic): Consent, Screening (incl. blood sample) and
           device training, training to emergency behavior; Pump Start in low glucose suspend mode,
           alarm settings

        -  Visit 2 - Week 1: Subjects come to clinic; start Run-in Period and start Sensor
           Augmented Pump (SAP) therapy without any SmartGuard feature, assessment of AEs; pump
           will be read out, data stored; subjects will be trained to use the Auto mode, Auto mode
           will be activated. All subjects will participate in a 11-week study period.

        -  Visit 3 - Week 2: Subjects are randomized to start with SAP or Hybrid Closed Loop (HCL)
           therapy and stay with an assigned therapy for next 4 weeks.

        -  Visit 4 - Week 6: End of Period 1 and start of washout period. Subjects stay in this
           period with SAP therapy only. Evaluation of past 4 weeks, assessment of AEs

        -  Visit 5 - Week 7: Period 2 starts. Evaluation of past week, assessment of AEs. SAP group
           will be using 670G with HCL and HCL group will be using SAP therapy for next 4 weeks.

        -  Visit 6 - Week 11: End of Study, Subjects come to clinic; evaluation of past 4 weeks,
           assessment of AEs, HbA1c; pump will be read out, data stored. All study material will be
           given back.
    

Intervention name(s): Medtronic MiniMed 670G Insulin Pump in Auto Mode; Medtronic MiniMed 670G Insulin Pump without Auto Mode
Intervention type(s): Device; Device
Intervention description(s): This kind of intervention will be part of the intensified insulin therapy for type 1 diabetic patients. The system will help to keep blood glucose in a defined range by automatic assisted adaption of insulin dosing.the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.; Sensor augmented pump 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. There is no automatic adaption of insulin dosing. The patients must respond manually after alarm or according to the trend arrows.
Other intervention name(s): Hybrid Closed Loop (HCL) System; Sensor Augmented Pump therapy without Auto Mode
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; type 1 diabetes; insulin pump; closed loop