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

NCT ID: NCT01775059

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31

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.

Conditions

Diabetes Mellitus Type I; Diabetes Mellitus Type II

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integrated sensor and infusion set.

Group Type: EXPERIMENTAL

Integrated sensor and infusion set.

Intervention Type: DEVICE

Interventions

Integrated sensor and infusion set.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes R&D Denmark

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrik Pedersen-Bjergaard, MD

Role: PRINCIPAL_INVESTIGATOR

Hilleroed Hospital

Locations

Fredericia Hospital

Fredericia, , Denmark

Hilleroed Hospital

Hilleroed, , Denmark

Hvidovre Hospital

Hvidovre, , Denmark

Countries

Denmark

Central Contacts

Ulrik Pedersen-Bjergaard, MD

Role: CONTACT

ulrik.pedersen-bjergaard@regionh.dk

Facility Contacts

Hans Gjessing, MD

Role: primary

hans.gjessing@slb.regionsyddanmark.dk

Ulrik Pedersen-Bjergaard, MD

Role: primary

ulrik.pedersen-bjergaard@regionh.dk

Kirsten Norgaard, MD

Role: primary

kirsten.noergaard@regionh.dk

Other Identifiers

2012102304

Identifier Type: -

Identifier Source: secondary_id

CEP 277

Identifier Type: -

Identifier Source: org_study_id