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

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

U.S. FDA Resources

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 ]

Estimated Enrollment:	70
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2012
Estimated 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

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:

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

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

Exclusion Criteria:

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
Patients participating in other device or drug studies

Contacts and Locations

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:	June 4, 2012
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 June 17, 2013