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

Medtronic

Status: Unknown

Conditions: Diabetes Mellitus Type II; Diabetes Mellitus Type I

Treatments: Device: Integrated sensor and infusion set.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775059

CEP 277

2012102304

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Integrated sensor and infusion set.

Experimental group

Treatment:

Device: Integrated sensor and infusion set.