Diabetes MellitusNCT01989975

CareLink Connect - Technical Evaluation Study

An observational study of Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the performance, patient satisfaction and safety of connectivity gateway device CareLink Connect, transferring CGM (Continuous Glucose Monitoring) data from a VEO insulin pump to CareLink online (every 5th minute) and thereby making it available for patients or Care Partners… Read more about this study

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Diabetes Mellitus
How many people: 40 participants
Where: 2 sitesin 2 countries
Study dates: May 2013to Sep 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Clinic patients

Who may be able to join

Subject between the age of 12 - 65 years that has a clinical diagnosis of insulin requiring diabetes for at least 1 year
Subject is currently using a Paradigm® Veo™ Medtronic insulin pump for at least 3 months and willing to continue to use for the duration of the study.
Subject has sufficient Continuous Glucose Monitoring use experience, as determined by the Investigator, and is willing to continuously use CGM for the duration of the study.
Guidelines to evaluate the patients experience are:
Subject has a minimum of 30 days of CGM use within a year prior to enrollment.
Subject has experience with and is able to, or has a Care Partner who can:

Show all 17Show fewer

Insert/change sensor,
Recharge the transmitter.
Read sensor data in real-time on the insulin pump screen.
Subject is willing to, or has a Care Partner who can, perform at least the minimum required (2 per day) Blood Glucose readings to maintain CGM Sensor calibration.
Subject, if under the age of 18, has a Care Partner who is willing to participate to the study, attend the study visit with the subject, and complete user's feedback questionnaires and Care Partner diary. Care Partners are optional for patients of 18 years of age or older.
Subject and/or Care Partner have access to a computer with Internet access.
Subject and/or Care Partner have access to an Internet connected device.
Subject, or their legal guardian, is willing to allow a Care Partner to receive and view information transmitted by their Paradigm® Veo™ Medtronic insulin pump to a Mobile phone/Smartphone/tablet/PC via the CareLink Connect/CareLink Personal System.
Subject is willing to keep CareLink Connect device in the same room as themselves or regularly carry the study device with them and maintain its operational status (at approximately 16h per 24h).
Subject is willing to keep a short diary during the device use reporting time periods away(for more than one hour) from the CareLink Connect device.
Subject is in good general health as judged by the PI.

Who cannot join

Female subject is pregnant, per urine pregnancy test performed at screening in women of child-bearing potential
Female subject plans to become pregnant during the course of the study
Subject is unable to tolerate tape adhesives of the infusion set and CGM sensor
Subject has any unresolved adverse skin condition in the area of the pump infusion set or the CGM sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
The subject has known cellular connectivity problem at their home
The subject is by the PI judged ineligible or unable to perform the study procedures jeopardizing the study results.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Denmark1 site

Steno Diabetes Center
Gentofte Municipality, 2820

Other trials in Denmark

Netherlands1 site

Diabeter
Rotterdam, 3011

Other trials in Netherlands

About this study

Official title: A Multi-center, Non-randomized Study in Subjects With Diabetes Mellitus Treated With Sensor-Augmented Pump Therapy to Evaluate the Performance and Safety of CareLink Connect Transferring Pump Data to Web Connected Devices Via CareLink

Conditions: Diabetes Mellitus
Keywords: Sensor-Augmented Pump Therapy, Connected Care
Medical subject headings: Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

CareLink Connect Activity: % of the Time Per Day When Cellular Connection Was Established
The overall system connectivity between the pump, the CareLink Connect device, and the CareLink server will be measured. CareLink Connect activity will be measured by:
- Date and time of CareLink Connect transmissions
- Transmission type and data sent in CareLink Connect transmissions (includes RF messages and history uploads)
Measured: Outcome measured after 15 days of use of the CareLink Connect Device
Subject Experience After Using the Carelink Connect Device
Subject experience after using the Carelink Connect device was evaluated with questionnaires. Subjects were asked the question: I felt that I had good control over my diabetes. Likert Scale of 1-7 was used in the study to evaluate the question (1 being the the worse, 4 being neutral and 7 being the best).
Measured: Outcome measured after 15 days of use of the CareLink Connect Device

Secondary outcomes (2)

Number of Participants With Serious Adverse Events
Descriptive summary of number and type of serious adverse events (SAE)
Measured: Outcome measured after 15 days of use of the CareLink Connect Device
Number of Participants With Investigational Device Deficiencies
Subjects were instructed to report any inadequacies of a medical device including:
- Lack of connection between the CareLink Connect device and the Veo pump (Connectivity issues)
- Device Battery issue
- Device information display issue
Measured: Outcome measured after 15 days of use of the CareLink Connect Device

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Sep 2013

First posted21 Nov 2013 (estimated)
Study startMay 2013
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01989975
Sponsor's protocol ID: EUR06
Status last verified: Oct 2018
First submitted: 22 Apr 2013
Last updated: 21 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Non-randomized Study in Subjects With Diabetes Mellitus Treated With Sensor-Augmented Pump Therapy to Evaluate the Performance and Safety of CareLink Connect Transferring Pump Data to Web Connected Devices Via CareLink
ClinicalTrials.gov ID: NCT01989975
Acronym / sponsor ID: EUR06
Conditions: Diabetes Mellitus
Keywords: Sensor-Augmented Pump Therapy, Connected Care
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: May 2013 (actual)
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 21 Nov 2013 (estimated)
Results: Posted 21 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Clinic patients

Key inclusion criteria (17 listed)

Subject between the age of 12 - 65 years that has a clinical diagnosis of insulin requiring diabetes for at least 1 year
Subject is currently using a Paradigm® Veo™ Medtronic insulin pump for at least 3 months and willing to continue to use for the duration of the study.
Subject has sufficient Continuous Glucose Monitoring use experience, as determined by the Investigator, and is willing to continuously use CGM for the duration of the study.
Subject is willing to, or has a Care Partner who can, perform at least the minimum required (2 per day) Blood Glucose readings to maintain CGM Sensor calibration.
Subject, if under the age of 18, has a Care Partner who is willing to participate to the study, attend the study visit with the subject, and complete user's feedback questionnaires and Care Partner diary. Care Partners are optional for patients of 18 years of age or older.

Key exclusion criteria (6 listed)

Female subject is pregnant, per urine pregnancy test performed at screening in women of child-bearing potential
Female subject plans to become pregnant during the course of the study
Subject is unable to tolerate tape adhesives of the infusion set and CGM sensor
Subject has any unresolved adverse skin condition in the area of the pump infusion set or the CGM sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
The subject has known cellular connectivity problem at their home

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

CareLink Connect Activity: % of the Time Per Day When Cellular Connection Was Established
Time frame: Outcome measured after 15 days of use of the CareLink Connect Device
The overall system connectivity between the pump, the CareLink Connect device, and the CareLink server will be measured. CareLink Connect activity will be measured by: * Date and time of CareLink Connect transmissions * Transmission type and data sent in CareLink Connect transmissions (includes RF messages and history uploads)
Subject Experience After Using the Carelink Connect Device
Time frame: Outcome measured after 15 days of use of the CareLink Connect Device
Subject experience after using the Carelink Connect device was evaluated with questionnaires. Subjects were asked the question: I felt that I had good control over my diabetes. Likert Scale of 1-7 was used in the study to evaluate the question (1 being the the worse, 4 being neutral and 7 being the best).

2 secondary outcomes

Number of Participants With Serious Adverse Events
Time frame: Outcome measured after 15 days of use of the CareLink Connect Device
Number of Participants With Investigational Device Deficiencies
Time frame: Outcome measured after 15 days of use of the CareLink Connect Device

Results and safety

Results posted to the registry on 21 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetes Subjects With Sensor-Augmented Pump Therapy	40	40

Primary outcome: CareLink Connect Activity: % of the Time Per Day When Cellular Connection Was Established

Time frame: Outcome measured after 15 days of use of the CareLink Connect Device. Mean (Standard Deviation). Unit: percentage of time spent connected

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n = 40
Value	89.3 (12.4)

Primary outcome: Subject Experience After Using the Carelink Connect Device

Time frame: Outcome measured after 15 days of use of the CareLink Connect Device. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Diabetes Subjects With Sensor-Augmented Pump Therapy n = 40
Value	5.6 (1.1)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetes Subjects With Sensor-Augmented Pump Therapy	0 of 40 (0%)	9 of 40 (22.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 2 sites in 2 countries.

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 17 inclusion and 6 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, Netherlands. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

CareLink Connect Activity: % of the Time Per Day When Cellular Connection Was Established (time frame: Outcome measured after 15 days of use of the CareLink Connect Device). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01989975.

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 21 Feb 2019.