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

This study is not yet open for participant recruitment.

Verified January 2013 by Medtronic Diabetes R&D Denmark

Sponsor:

Information provided by (Responsible Party):

Medtronic Diabetes R&D Denmark

ClinicalTrials.gov Identifier:

NCT01775059

First received: January 21, 2013

Last updated: February 4, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2013

Last Updated Date

February 4, 2013

Start Date ^ICMJE

March 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Agreement Rate (% within 20%) using VEO Pump
Safety endpoint [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
Descriptive summary of SAE, Adverse events and Device complaints

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01775059 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]

MARD(%), BIAS(mg/dl), MAD(mg/dl) during study

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus Type I
Diabetes Mellitus Type II

Intervention ^ICMJE

Device: Integrated sensor and infusion set.

Study Arm (s)

Experimental: Integrated sensor and infusion set.

Intervention: Device: Integrated sensor and infusion set.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ulrik Pedersen-Bjergaard, MD

ulrik.pedersen-bjergaard@regionh.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01775059

Other Study ID Numbers ^ICMJE

CEP 277, 2012102304

Has Data Monitoring Committee

Not Provided

Responsible Party

Medtronic Diabetes R&D Denmark

Study Sponsor ^ICMJE

Medtronic Diabetes R&D Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ulrik Pedersen-Bjergaard, MD

Hilleroed Hospital

Information Provided By

Medtronic Diabetes R&D Denmark

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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