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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The Libre- flash glucose monitoring system is an episodic real-time data on demand device. This means that patients can measure their glucose level when they choose by scanning the device, while at the same time a sensor automatically measures and continuously stores glucose readings day and night. Every scan shows the current glucose reading and the last 8 hours of glucose. There are no alarms and the system does not require calibration.
In the present study we aim to evaluate treatment satisfaction and comfort using the Libre flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose monitoring.
The second aim of the study is to evaluate the rate of use and the impact of Libre use compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally controlled and stopped using Continuous Glucose Monitoring. The study is an investigator initiated study, single-center, randomized, parallel study of 12 weeks with an optional cross-over 12 weeks extension period .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Libre Flash CGMS (Continuous Monitoring System) | Experimental | Patients will use the Libre Flash Continuous Glucose Monitoring System for 12 weeks for their glucose Management |
|
| SMBG | Active Comparator | Patients will use Self-Monitoring of Blood Glucose for 12 weeks for their glucose management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Libre Flash CGMS | Device |
| ||
| Self-Measurement Blood Glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Treatment satisfaction questionnaire | At the final visit- week 12 | |
| Libre-user evaluation questionnaire | 20-item questionnaire that asses treatment satisfaction with the Libre including ease of use, comfort, pain, design and system operation. The questionnaire will be scored to a final score integrating all items to a total score | At the final visit-week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control measured by HbA1c | At the final visit-week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of blood glucose measurements at each arm | At the final visit-week 12 | |
| Number of flash glucose measurements at the intervention arm | At the final visit-week 12 | |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center | Petah Tikva | 49202 | Israel |
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| Device |
Patients will use their personal glucose meter to perform Self-Measurement Blood Glucose |
|
| Percentage of glucose sensor readings within the range of 70 to 180 mg/dl |
| At the final visit-week 12 |
| Percentage of glucose sensor readings below 60 mg/dl | At the final visit-week 12 |
| Percentage of glucose sensor readings above 240 mg/dl | At the final visit-week 12 |
| Average of glucose sensor readings | Average of glucose sensor readings (per 24 hours) | Week 12 |
| Standard Deviation of glucose sensor readings | Standard Deviation of glucose sensor readings (per 24 hours) ) | Week 12 |
| HbA1c change from baseline to the end of the first intervention period | At the final visit-week 12 |
| HbA1c change from baseline to the end of the second intervention period | At the final visit-week 12 |
| Average fasting blood glucose level | At the final visit-week 12 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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