MDRS for Prevention of Nocturnal Hypoglycemia

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Nocturnal Hypoglycemia in Children and Young Adults With Type 1 Diabetes Using a Remote Safety and Control Diabetes Management System

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: MDRS System (Remote & Safety diabetes management system)
* Procedure: Continuous Glucose Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes diagnosed at least 1 year prior to study entry Continuous subcutaneous insulin infusion pump for at least 3 month prior to study entry Use of continuous glucose measurement device for at least one month prior to study entry Age: 4-24 years old HbA1c < =8.5% No more than one severe hypoglycemia or an episode diabetic ketoacidosis within the year prior to study entry, and none within the month prior to study entry. Capable of reading a pump screen in English Capable of operating the MDRS software A patient older than 18 years- leaving routinely with at least one more adult(age above 18 years) capable of connecting the C&C center and properly reacting to the instructions given by the attending personal. A patient younger than 18 years- leaving routinely with at least two adults (age above 18 years) capable of connecting the C&C center and properly reacting to the instructions given by the attending personal. All participants must provide an adult independent contact person, leaving near by the participant, capable of connecting the C&C center and properly reacting to the instructions given by the attending personal. This person will be called into action in emergency cases in which the participant or his household members can not be reached. Capable of completing the hypoglycemia the relevant surveys Able to understand and sign an informed consent forms Exclusion Criteria: Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study. Patients participating in other device or drug studies Known dermal hypersensitivity to trial products or those that contain medical adhesive Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication for participation in the study. Inability to understand/complete the hypoglycemia fear survey Female subject who is pregnant or planning to become pregnant within the planned study duration

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 24 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDRS system<br>Participants will be using the MDRS system combined with their regular treatment with 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 | Device: MDRS System (Remote & Safety diabetes management system)<br>* 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<br>|
| Active Comparator: Continuous Glucose Monitoring<br>Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system | Procedure: Continuous Glucose Monitoring<br>* Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in time spent in hypoglycemia |  | 4 weeks (end of study period) | 
| Parental fear of hypoglycemia |  | 4 weeks ( end of study pariod) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Treatment Satisfaction | We will measure the change in Treatment Satisfaction using questioner and calculation of the the satisfaction score | 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 | 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 | 4 weeks (end of study period) | 
| Average and median of blood glucose levels |  | 4 weeks (end of study period) | 
| Percentage of time spent below 63 mg/dl |  | 4 weeks (end of study period) | 
| Percentage of time spent above 140,180,250 mg/dl |  | 4 weeks (end of study period) | 
| Glucose variability | Glucose variability measured by glucose Standard Deviation and Kovatchev indexes | 4 weeks (end of study period) | 
| Hypoglycemic events-number and severity of episodes |  | 4 weeks (end of study period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Continuous Glucose Monitoring, Nocturnal Hypoglycemia