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

Phase 4

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Medtronic CareLink therapy management system; Other: regular home use and Medtronic CareLink Therapy Management

• Registration Number: NCT00814476
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2008-12-23
• Study First Submitted QC: 2008-12-23
• Study First Posted: 2008-12-24
• Study Start: 2009-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. CareLink team supported group	Medtronic CareLink therapy management system	CareLink team supported group
2	regular home use and Medtronic CareLink Therapy Management	Regular treated group in the first segment and CareLink treated group in the second segment

Primary Outcome Measures

Name	Time	Method
HbA1c	At Baseline and every 4 month after

Secondary Outcome Measures

Name	Time	Method
Hypoglycemic events	will be recorded through the whole study period
DKA and ketosis events	will be recorded through the whole study period
7 points glucose profile	Will be recorded 2 days before baseline visit and every 4 months after
Patient's satisfaction and quality of life questionnaire	At baseline visit and every 4 months after

Trial Locations

Locations (1)

Schnider children medical center; 🇮🇱 Petach-Tikva, Israel