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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.
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| 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:
| 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 |
| 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 |
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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:
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:
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Clinic patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center | Gentofte Municipality | 2820 | Denmark | |||
| Diabeter |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetes Subjects With Sensor-Augmented Pump Therapy | Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetes Subjects With Sensor-Augmented Pump Therapy | Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Mean | Standard Deviation | percentage of time spent connected | Outcome measured after 15 days of use of the CareLink Connect Device |
|
15 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetes Subjects With Sensor-Augmented Pump Therapy | Subjects with diabetes mellitus treated with Sensor-Augmented Pump therapy participated the study for 15 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suiying Huang, Statistician | Medtronic Minimed | 8184763319 | suiying.huang@medtronic.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Subjects were instructed to report any inadequacies of a medical device including:
|
| Outcome measured after 15 days of use of the CareLink Connect Device |
| Rotterdam |
| 3011 |
| Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | Scores on a Scale | Outcome measured after 15 days of use of the CareLink Connect Device |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events | Descriptive summary of number and type of serious adverse events (SAE) | Posted | Count of Participants | Participants | Outcome measured after 15 days of use of the CareLink Connect Device |
|
|
|
| Secondary | Number of Participants With Investigational Device Deficiencies | Subjects were instructed to report any inadequacies of a medical device including:
| Posted | Count of Participants | Participants | Outcome measured after 15 days of use of the CareLink Connect Device |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 9 |
| 40 |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Severe common cold | Infections and infestations | Non-systematic Assessment |
|
| Minor nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Cold | Infections and infestations | Non-systematic Assessment |
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| Fever | Infections and infestations | Non-systematic Assessment |
|
| Infection external ear | Infections and infestations | Non-systematic Assessment |
|
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| No Issues |
|