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

Type 1 Diabetes Clinical Trial

— CareLink  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814476
• Other study ID #: rmc005047ctil
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2008
• Last updated: July 9, 2013
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health services
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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
• 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.

Locations

Country	Name	City	State
Israel	Schnider children medical center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		At Baseline and every 4 month after	No
Secondary	Hypoglycemic events		will be recorded through the whole study period	Yes
Secondary	DKA and ketosis events		will be recorded through the whole study period	Yes
Secondary	Patient's satisfaction and quality of life questionnaire		At baseline visit and every 4 months after	No
Secondary	7 points glucose profile		Will be recorded 2 days before baseline visit and every 4 months after	Yes