CareLink Connect - Technical Evaluation Study

Study Overview
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Brief Summary
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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.

Official Title
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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
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Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | Outcome measured after 15 days of use of the CareLink Connect Device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events | Descriptive summary of number and type of serious adverse events (SAE) | 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 | Outcome measured after 15 days of use of the CareLink Connect Device | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensor-Augmented Pump Therapy, Connected Care