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ClinicalTrials.gov ID

NCT01775059

Lead Sponsor

Medtronic Diabetes R&D DenmarkINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

50Estimated

Last Update Posted

Feb 5, 2013Estimated

Start Date

Mar 2013

Primary Completion Date

Jul 2013Estimated

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.

• Diabetes Mellitus Type I
• Diabetes Mellitus Type II

• Integrated sensor and infusion set.

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Medtronic Diabetes R&D DenmarkINDUSTRY

kirsten.noergaard@regionh.dk