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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDRS system | Experimental | 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 |
|
| Continuous Glucose Monitoring | Active Comparator | Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDRS System (Remote & Safety diabetes management system) | Device | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Medical Center | Petah Tikva | 49202 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25211216 | Derived | Oron T, Farfel A, Muller I, Miller S, Atlas E, Nimri R, Phillip M. A remote monitoring system for artificial pancreas support is safe, reliable, and user friendly. Diabetes Technol Ther. 2014 Nov;16(11):699-705. doi: 10.1089/dia.2014.0090. Epub 2014 Sep 11. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Continuous Glucose Monitoring | Procedure | Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system |
|
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) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |