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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accu-Chek Combo | 15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek Combo System | Device | 12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Treatment Satisfaction | we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires | after 12 weeks |
| Study device acceptance | We will assess study device acceptance using a distinct Acceptance Questionnaire | after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose level | we will compare mean blood glucose level at baseline and after 12 weeks | after 12 weeks |
| Number of Hypoglycemia Events | we will compare the number of hypoglycemia events at baseline and after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Young patients with type 1 Diabetes treated at the institute of Endocrinology and Diabetes, Schneider Children's Medical Center, which is a tertiary hospital
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Schneider Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's 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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| after 12 weeks |
| Number of Hyperglycemia Events | We will compare the number of hyperglycemia events at baseline and after 12 weeks | after 12 weeks |
| HbA1c | We will compare HbA1c level at baseline and after 12 weeks | after 12 weeks |
| postprandial SMBG (self monitoring blood glucose) | We will compare between postprandial SMBG at baseline and after 12 weeks | after 12 weeks |
| Overall number of BG (Blood glucose) measurements | We will compare between number of BG measurements at baseline and after 12 weeks | after 12 weeks |
| Number of ketosis events | We will compare number of ketosis events (without documented acidosis with home/hospital management)at baseline and after 12 weeks | after 12 weeks |
| Number of Diabetic Ketoacidosis (DKA) events | We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks | after 12 weeks |
| preprandial SMBG (self monitoring blood glucose) | We will compare between preprandial SMBG at baseline and after 12 weeks | after 12 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |