Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00814476
First received: December 23, 2008
Last updated: July 9, 2013
Last verified: July 2013

December 23, 2008
July 9, 2013
January 2009
December 2012   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: At Baseline and every 4 month after ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00814476 on ClinicalTrials.gov Archive Site
  • Hypoglycemic events [ Time Frame: will be recorded through the whole study period ] [ Designated as safety issue: Yes ]
  • DKA and ketosis events [ Time Frame: will be recorded through the whole study period ] [ Designated as safety issue: Yes ]
  • Patient's satisfaction and quality of life questionnaire [ Time Frame: At baseline visit and every 4 months after ] [ Designated as safety issue: No ]
  • 7 points glucose profile [ Time Frame: Will be recorded 2 days before baseline visit and every 4 months after ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System.
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

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:

  1. Metabolic control as expressed by HbA1c.
  2. Hypoglycemic events- number and severity of episodes.
  3. DKA and ketosis events- number and severity of episodes.
  4. Patient's satisfaction and quality of life measured by treatment satisfaction and quality of life questionnaires.
  5. 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Type 1 Diabetes
  • 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
  • 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.
  • Active Comparator: 2
    Regular treated group in the first segment and CareLink treated group in the second segment
    Intervention: Other: regular home use and Medtronic CareLink Therapy Management
  • Experimental: 1. CareLink team supported group
    CareLink team supported group
    Intervention: Other: Medtronic CareLink therapy management system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Type 1 diabetes diagnosed at least 6 months prior to study entry
  2. Current treatment with Medtronic 722 /712 external insulin pump systems
  3. Treatment with insulin pump at least 3 month prior to study entry
  4. An internet access from patient's home
  5. Age 0-35 years old
  6. HbA1c>7.8
  7. Signing inform consent forms

Exclusion Criteria:

  1. 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
  2. Patients participating in other device or drug studies
Both
up to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00814476
rmc005047ctil
No
Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Moshe Phillip, Professor Rabin Medical Center
Rabin Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP