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NCT Number: NCT00814476

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Schnider children medical center

Petah Tikva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. HbA1c

    Time frame: At Baseline and every 4 month after

Secondary outcomes

  1. Hypoglycemic events

    Time frame: will be recorded through the whole study period

  2. DKA and ketosis events

    Time frame: will be recorded through the whole study period

  3. Patient's satisfaction and quality of life questionnaire

    Time frame: At baseline visit and every 4 months after

  4. 7 points glucose profile

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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study 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

Acronym: CareLink

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2008
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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