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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus Type II; Diabetes Mellitus Type I
• Intervention / Treatment: Device: Integrated sensor and infusion set.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Fredericia, Denmark, 7000
    • Fredericia Hospital
  • Hilleroed, Denmark, 3400
    • Hilleroed Hospital
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated sensor and infusion set.	Device: Integrated sensor and infusion set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy endpoint	Agreement Rate (% within 20%) using VEO Pump	5 months
Safety endpoint	Descriptive summary of SAE, Adverse events and Device complaints	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy endpoint	Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data	5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy endpoint	MARD(%), BIAS(mg/dl), MAD(mg/dl) during study	5 months

Collaborators and Investigators

• Sponsor: Medtronic Diabetes R&D Denmark
• Investigators: Principal Investigator: Ulrik Pedersen-Bjergaard, MD, Hilleroed Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CEP 277; 2012102304