CareLink Connect - Technical Evaluation Study

NCT ID: NCT01989975

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-09-30

Brief 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 individual web connected devices such as smartphones, tablets and PCs.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Subject between the age of 12 - 65 years that has a clinical diagnosis of insulin requiring diabetes for at least 1 year

2. 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.

3. 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:

i. Subject has a minimum of 30 days of CGM use within a year prior to enrollment.

ii. Subject has experience with and is able to, or has a Care Partner who can:

1. Insert/change sensor,

2. Recharge the transmitter.

3. Read sensor data in real-time on the insulin pump screen.

4. 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.

5. 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.

6. Subject and/or Care Partner have access to a computer with Internet access.

7. Subject and/or Care Partner have access to an Internet connected device.

8. 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.

9. 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).

10. 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.

11. Subject is in good general health as judged by the PI.

Exclusion Criteria

1. Female subject is pregnant, per urine pregnancy test performed at screening in women of child-bearing potential

2. Female subject plans to become pregnant during the course of the study

3. Subject is unable to tolerate tape adhesives of the infusion set and CGM sensor

4. 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)

5. The subject has known cellular connectivity problem at their home

6. The subject is by the PI judged ineligible or unable to perform the study procedures jeopardizing the study results.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Steno Diabetes Center

Gentofte Municipality, , Denmark

Diabeter

Rotterdam, , Netherlands

Countries

Denmark; Netherlands

Other Identifiers

EUR06

Identifier Type: -

Identifier Source: org_study_id