Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4

Not Applicable

• Conditions: Diabetes Mellitus Type I; Diabetes Mellitus Type II
• Interventions: Device: Integrated sensor and infusion set.

• Registration Number: NCT01775059
• Lead Sponsor: Medtronic Diabetes R&D Denmark

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-24
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05
• Study Start: 2013-03
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subject is 18 years of age or older at time of screening
• Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
• 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.
• Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
• Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
• Subject is willing to wear the study devices for the duration of the study
• Subject is willing to perform frequent (min 7 per day) SMBGs during study device wear
• Subject is willing to keep a short diary during the device wear.

Exclusion Criteria

• Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
• Female subject plans to become pregnant during the course of the study.
• Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
• Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
• The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrated sensor and infusion set.	Integrated sensor and infusion set.	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Accuracy endpoint	5 months	Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data

Trial Locations

Locations (3)

Hilleroed Hospital; 🇩🇰 Hilleroed, Denmark

Fredericia Hospital; 🇩🇰 Fredericia, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark