Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)

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.

Inclusion criteria

General 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 will be considered for enrollment in the study if they meet all of the following 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
• Subject may also be on sensor augmented pump therapy.
• If subject has celiac disease it has been adequately treated as proven by Transglutamase-Antibodies in normal range

Exclusion criteria

• 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
• Subject tests positive in the drug screen
• Subject has taken any oral, injectable, or IV steroids within 8 weeks prior time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study; furthermore patients using antipsychotic drugs, antidepressive, ß-blocking agents are not permitted to participate
• Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 4 weeks
• 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 history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
• Subject has elective surgery planned that requires general anesthesia during the course of the study
• 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
• Subjects known for factitial hypoglycemia or possible suicidal tendencies.
• Patients who are unwilling or unable to perform a minimum of four blood glucose tests per day.
• People who are unwilling or unable to maintain contact with their healthcare professional.

Patients whose vision or hearing does not allow cognition of pump signals and alarms.