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

NCT ID: NCT00814476

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

2

Regular treated group in the first segment and CareLink treated group in the second segment

Group Type: ACTIVE_COMPARATOR

regular home use and Medtronic CareLink Therapy Management

Intervention Type: OTHER

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.

1. CareLink team supported group

CareLink team supported group

Group Type: EXPERIMENTAL

Medtronic CareLink therapy management system

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, Professor

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Schnider children medical center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

rmc005047ctil

Identifier Type: -

Identifier Source: org_study_id