The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System. (CareLink)
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|ClinicalTrials.gov Identifier: NCT00814476|
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : July 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Other: Medtronic CareLink therapy management system Other: regular home use and Medtronic CareLink Therapy Management||Phase 4|
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.
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.
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
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: 2
Regular treated group in the first segment and CareLink treated group in the second segment
Other: regular home use and Medtronic CareLink Therapy Management
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.
Experimental: 1. CareLink team supported group
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814476
|Schnider children medical center|
|Principal Investigator:||Moshe Phillip, Professor||Rabin Medical Center|