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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability.
Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp.
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark.
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability.
Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp.
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark.
The primary objective of the study is to characterize the overall management of the glycemic control using this system including Safety. The data collected in this study will be used to confirm/develop the HLCL System further.
Secondary objectives of this study include evaluation of the HLCL system in a monitored setting (camp) with the following stresses:Exercise, high carbohydrate and high fat meals
This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy.
Run-in Period:
A total of up to 10 subjects will be enrolled (age 18-40). A minimum of 6 days run-in period with sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar.
Study Period - Camp:
Following the run-in period subjects will participate in a 5 day, 4 night study period in a camp setting during which the HLCL feature will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Loop System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLCL- Hybrid Logic Closed Loop System | Device | All subjects wearing the HLCL System and using it with the closed loop algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL, | End of the study- day 5 of the camp | |
| Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during night time (12am-6am) | End of the study- day 5 of the camp | |
| Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during day time (6am-12am) | End of the study- day 5 of the camp |
| Measure | Description | Time Frame |
|---|---|---|
| Event rate of Serious Adverse Events | End of the study- day 5 of the camp | |
| Event rate of Serious Adverse Device Events | End of the study- day 5 of the camp | |
| Event rate of unanticipated Adverse Device Effects |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in Closed Loop | End of study -day 5 of the camp | |
| Total insulin dose | End of study-day 5 of the camp |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, MD, Prof | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Medical Center | Petah Tikva | 49202 | Israel |
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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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| End of the study-day 5 of the camp |
| Incidence of Diabetic Ketoacidosis | End of the study-day 5 of the camp |
| Area under the curve of time in the hyperglycemia range | End of the study-day 5 of the camp |
| Area Under the curve of time in the hypoglycemic range | End of the study-day 5 of the camp |
| Incidence of Severe Hypoglycemia | End of study -day 5 of the camp |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |