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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Other: Medtronic CareLink therapy management system
Other: regular home use and Medtronic CareLink Therapy Management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: At Baseline and every 4 month after ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814476

Locations
Israel
Schnider children medical center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Professor Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00814476     History of Changes
Other Study ID Numbers: rmc005047ctil
Study First Received: December 23, 2008
Last Updated: July 9, 2013
Health Authority: Israel: Clalit Health services

Keywords provided by Rabin Medical Center:
Medtronic CareLink
therapy management
diabetes
insulin pump
Blood glucose monitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014