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Randomized, two arms, controlled, open study comprised of two consecutive segments. At the first segment that will last during the first 4 months of the study, patients will be randomized to the Care link treated group or non Care link treated group. At this segment of the study the usage of the Care link system will be accompanied by the diabetic team, through at least monthly contact via the Internet initiated by the diabetic team. At the second segment of the study, during the following 4 months, both groups will use the Care link System, home-use, without support initiated by the diabetic team.
A randomized, two arms, controlled, open study in order to compare the efficacy, short and long term effects of regular home-use Vs diabetic team- supported use of the Medtronic CareLink therapy management system in patients with diabetes.
Primary objective:
To assess the efficacy, short term (4 months) and long term (8 months) effects of using the Medtronic CareLink® Therapy Management System for Diabetes on the following parameters:
Secondary objective:
To compare the efficacy of 4 months treatment using the CareLink® Therapy Management System, accompanied with intensive contact (at least once a month) initiated by diabetic team via the internet/electronic mail Vs home use treatment - without monthly contact initiated by the diabetic team
Study design:
The study will be comprised of two consecutive segments. At the first segment that will last during the first 4 months of the study, patients will be randomized to the CareLink treated group or non CareLink treated group. At this segment of the study the usage of the CareLink system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. At the second segment of the study, during the following 4 months, both groups will use the CareLink system, home-use, without support initiated by the diabetic team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Regular treated group in the first segment and CareLink treated group in the second segment |
|
| 1. CareLink team supported group | Experimental | CareLink team supported group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic CareLink therapy management system | Other | At the first segment, the usage of the CareLink system will be accompanied by the diabetic team, through at least monthly contact via the internet initiated by the diabetic team. In the second phase of the study,during the following 4 months, there will be regular home use of the CareLink system, without support initiated by the diabetic team |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | At Baseline and every 4 month after |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic events | will be recorded through the whole study period | |
| DKA and ketosis events | will be recorded through the whole study period | |
| Patient's satisfaction and quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Professor | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schnider children medical center | Petah Tikva | Israel |
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|
| regular home use and Medtronic CareLink Therapy Management | Other | At the first 4 months patients will continue at their regular treatment and contacts initiated by the study team via internet/electronic mail will be made once a month. At the second segment of the study patients there will be home use of the CareLink System until the end of the study. No further contact will be initiated by the study team. |
|
| At baseline visit and every 4 months after |
| 7 points glucose profile | Will be recorded 2 days before baseline visit and every 4 months after |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| 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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