The investigators have developed a unique Remote \& Safety diabetes management system (MDRS) that offers real-time remote monitoring and control of glucose levels. The system allows the supervising personal to alarm the patient and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in children and young adults with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
38
Participants will be using the MDRS system combined with their regular Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults
Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Schneider Medical Center
Petah Tikva, Israel
Reduction in time spent in hypoglycemia
Time frame: 4 weeks (end of study period)
Parental fear of hypoglycemia
Time frame: 4 weeks ( end of study pariod)
Change in Treatment Satisfaction
We will measure the change in Treatment Satisfaction using questioner and calculation of the the satisfaction score
Time frame: between week 0 (baseline) and week 4 (end of study period)
Percentage of time spent in the target range
Percentage of time spent in the target range, defined as sensor glucose level within 63-140 mg/dl
Time frame: 4 weeks (end of study period)
Percentage of time spent in the tight normal range
Percentage of time spent in the tight normal range, defined as sensor glucose level within 80 to 120 mg/dl
Time frame: 4 weeks (end of study period)
Average and median of blood glucose levels
Time frame: 4 weeks (end of study period)
Percentage of time spent below 63 mg/dl
Time frame: 4 weeks (end of study period)
Percentage of time spent above 140,180,250 mg/dl
Time frame: 4 weeks (end of study period)
Glucose variability
Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"
Time frame: 4 weeks (end of study period)
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Hypoglycemic events-number and severity of episodes
Time frame: 4 weeks (end of study period)