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

NCT00814476 | Completed Phase 4

• 1 other identifier: rmc005047ctil
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Medtronic CareLink; therapy management; diabetes; insulin pump; Blood glucose monitor

Outcome Measures

Primary Outcomes (1)

• HbA1c

  At Baseline and every 4 month after

Secondary Outcomes (4)

• Hypoglycemic events

  will be recorded through the whole study period

• DKA and ketosis events

  will be recorded through the whole study period

• Patient's satisfaction and quality of life questionnaire

  At baseline visit and every 4 months after

• 7 points glucose profile

  Will be recorded 2 days before baseline visit and every 4 months after

Study Arms (2)

2

ACTIVE COMPARATOR

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

Other: regular home use and Medtronic CareLink Therapy Management

1. CareLink team supported group

EXPERIMENTAL

CareLink team supported group

Other: Medtronic CareLink therapy management system

Interventions

Medtronic CareLink therapy management system 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

1. CareLink team supported group

regular home use and Medtronic CareLink Therapy Management 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.

2

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schnider children medical center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Phillip, Professor

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

IL (1)