Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
Study Details
Study Description
Brief Summary
This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days.
The purpose of this study is to collect performance data on the Integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Integrated sensor and infusion set.
|
Device: Integrated sensor and infusion set.
|
Outcome Measures
Primary Outcome Measures
- Accuracy endpoint [5 months]
Agreement Rate (% within 20%) using VEO Pump
- Safety endpoint [5 months]
Descriptive summary of SAE, Adverse events and Device complaints
Secondary Outcome Measures
- Accuracy endpoint [5 months]
Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data
Other Outcome Measures
- Accuracy endpoint [5 months]
MARD(%), BIAS(mg/dl), MAD(mg/dl) during study
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is 18 years of age or older at time of screening
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Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
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Subject is currently using a Medtronic Paradigm Sensor Augmented insulin pump and has been so for a minimum of 3 months at time of enrollment.
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Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
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Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
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Subject is willing to wear the study devices for the duration of the study
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Subject is willing to perform frequent (min 7 per day) SMBGs during study device wear
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Subject is willing to keep a short diary during the device wear.
Exclusion Criteria:
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Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
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Female subject plans to become pregnant during the course of the study.
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Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
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Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
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The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fredericia Hospital | Fredericia | Denmark | 7000 | |
| 2 | Hilleroed Hospital | Hilleroed | Denmark | 3400 | |
| 3 | Hvidovre Hospital | Hvidovre | Denmark | 2650 |
Sponsors and Collaborators
- Medtronic Diabetes R&D Denmark
Investigators
- Principal Investigator: Ulrik Pedersen-Bjergaard, MD, Hilleroed Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CEP 277
- 2012102304