A Phase 4 interventional study of Medtronic CareLink therapy management system and regular home use and Medtronic CareLink Therapy Management in Type 1 Diabetes, sponsored by Rabin Medical Center. Completed at 1 site in Israel. Open to participants aged Up to 35 Years. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by Rabin Medical Center · Phase 4, Interventional, and Supportive care
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Regular treated group in the first segment and CareLink treated group in the second segment
Other: regular home use and Medtronic CareLink Therapy Management
CareLink team supported group
Other: Medtronic CareLink therapy management system
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
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.
HbA1c
Time frame: At Baseline and every 4 month after
Hypoglycemic events
Time frame: will be recorded through the whole study period
DKA and ketosis events
Time frame: will be recorded through the whole study period
Patient's satisfaction and quality of life questionnaire
Time frame: At baseline visit and every 4 months after
7 points glucose profile
Time frame: Will be recorded 2 days before baseline visit and every 4 months after
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center