The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System.

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Metabolic control as expressed by HbA1c. Hypoglycemic events- number and severity of episodes. DKA and ketosis events- number and severity of episodes. Patient's satisfaction and quality of life measured by treatment satisfaction and quality of life questionnaires. 7 points glucose profile. 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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Medtronic CareLink therapy management system
* Other: regular home use and Medtronic CareLink Therapy Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes diagnosed at least 6 months prior to study entry Current treatment with Medtronic 722 /712 external insulin pump systems Treatment with insulin pump at least 3 month prior to study entry An internet access from patient's home Age 0-35 years old HbA1c>7.8 Signing inform consent forms Exclusion Criteria: Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study Patients participating in other device or drug studies

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Regular treated group in the first segment and CareLink treated group in the second segment | Other: regular home use and Medtronic CareLink Therapy Management<br>* 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.<br>|
| Experimental: 1. CareLink team supported group<br>CareLink team supported group | Other: Medtronic CareLink therapy management system<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | At Baseline and every 4 month after | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medtronic CareLink, therapy management, diabetes, insulin pump, Blood glucose monitor