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| Name | Class |
|---|---|
| University of Cambridge | OTHER |
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The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starting with FLORENCED2 followed by open loop | Experimental | Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop. |
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| Start open loop followed by FLORENCED2 | Experimental | Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLORENCED2 | Device | FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R |
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| Measure | Description | Time Frame |
|---|---|---|
| Time spent in normal glucose range ( mg/dl) | Glucose will be measured with a Continuous glucose monitoring device | At least 5 hours between 7 pm and 7 am |
| Measure | Description | Time Frame |
|---|---|---|
| glucose variability ( excursions in mg/dl) | Continuous Glucose Monitoring device | 7 pm - 7 am |
| Time spent in low glucose range (< 60 mg/dl) | Continuous Glucose Monitoring |
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Inclusion Criteria:
Exclusion Criteria:
-None
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| Name | Affiliation | Role |
|---|---|---|
| Carine deBeaufort, MD PhD | Centre Hospitalier du Luxembourg | Principal Investigator |
| Roman Hovorka, Professor | University of Cambridge | Principal Investigator |
| Gosia Wilinska, PhD | University of Cambridge | Principal Investigator |
| Ulrike Schierloh, MD | Centre Hospitalier du Luxembourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DECCP Clinique Pédiatrique de Luxembourg/CHL | Luxembourg | 1210 | Luxembourg | |||
| DECCP Pediatric Clinic , CHLuxembourg |
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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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| 7 pm till 7 am |
| time spent in low glucose range (<70 mg/dl) | continuous glucose monitoring | 7 pm till 7 am |
| time spent in high glucose range (>180mg/dl) | continuous glucose monitoring | 7 pm - 7 am |
| Luxembourg |
| 1210 |
| Luxembourg |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |