Clinical trial NCT00814476: The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: Medtronic CareLink
therapy management
diabetes
insulin pump
Blood glucose monitor
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-12-24
Enrollment: 70
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: At Baseline and every 4 month after
Secondary outcomes:
measure: Hypoglycemic events
timeFrame: will be recorded through the whole study period
measure: DKA and ketosis events
timeFrame: will be recorded through the whole study period
measure: Patient's satisfaction and quality of life questionnaire
timeFrame: At baseline visit and every 4 months after
measure: 7 points glucose profile
timeFrame: Will be recorded 2 days before baseline visit and every 4 months after
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schnider children medical center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip, Professor
role: PRINCIPAL_INVESTIGATOR
References: