Type 1 DiabetesPhase 4CareLinkNCT00814476
The Effects of Regular Home Use Vs Diabetic Team- Supported Use of the Medtronic CareLink Therapy Management System.
A Phase 4 study testing Medtronic CareLink therapy management system and regular home use and Medtronic CareLink Therapy Management in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 35 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Medtronic CareLink therapy management system and regular home use and Medtronic CareLink Therapy Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Medtronic CareLink therapy management system, regular home use and Medtronic CareLink Therapy Management
- Keywords
- Medtronic CareLink, therapy management, diabetes, insulin pump, Blood glucose monitor
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic CareLink therapy management systemOther
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 ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Regular treated group in the first segment and CareLink treated group in the second segment Receives: Other: regular home use and Medtronic CareLink Therapy Management |
| 1. CareLink team supported group | Experimental | CareLink team supported group Receives: Other: Medtronic CareLink therapy management system |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: At Baseline and every 4 month after
Secondary outcomes (4)
Hypoglycemic events
Measured: will be recorded through the whole study period
DKA and ketosis events
Measured: will be recorded through the whole study period
Patient's satisfaction and quality of life questionnaire
Measured: At baseline visit and every 4 months after
7 points glucose profile
Measured: Will be recorded 2 days before baseline visit and every 4 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Professor, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814476
- Sponsor's protocol ID
- rmc005047ctil
- Acronym
- CareLink
- Status last verified
- Jul 2013
- First submitted
- 23 Dec 2008
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00814476
- Acronym / sponsor ID
- CareLink / rmc005047ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Medtronic CareLink, therapy management, diabetes, insulin pump, Blood glucose monitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Other: regular home use and Medtronic CareLink Therapy ManagementRegular treated group in the first segment and CareLink treated group in the second segment |
| 1. CareLink team supported group | Experimental | Other: Medtronic CareLink therapy management systemCareLink team supported group |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic CareLink therapy management systemAt 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 | Other | 1. CareLink team supported group |
| regular home use and Medtronic CareLink Therapy ManagementAt 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. | Other | 2 |
Primary outcome
HbA1c
Time frame: At Baseline and every 4 month after
4 secondary outcomes
Hypoglycemic events
Time frame: will be recorded through the whole study period
DKA and ketosis events
Time frame: will be recorded through the whole study period
Patient's satisfaction and quality of life questionnaire
Time frame: At baseline visit and every 4 months after
7 points glucose profile
Time frame: Will be recorded 2 days before baseline visit and every 4 months after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Phillip, Professor principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medtronic CareLink therapy management system and regular home use and Medtronic CareLink Therapy Management in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: At Baseline and every 4 month after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.