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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

January 21, 2013
February 4, 2013
March 2013
July 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01775059 on ClinicalTrials.gov Archive Site
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
Same as current
Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]
MARD(%), BIAS(mg/dl), MAD(mg/dl) during study
Same as current
 
Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus Type I
  • Diabetes Mellitus Type II
Device: Integrated sensor and infusion set.
Experimental: Integrated sensor and infusion set.
Intervention: Device: Integrated sensor and infusion set.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Not Provided
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Ulrik Pedersen-Bjergaard, MD ulrik.pedersen-bjergaard@regionh.dk
Denmark
 
NCT01775059
CEP 277, 2012102304
Not Provided
Medtronic Diabetes R&D Denmark
Medtronic Diabetes R&D Denmark
Not Provided
Principal Investigator: Ulrik Pedersen-Bjergaard, MD Hilleroed Hospital
Medtronic Diabetes R&D Denmark
January 2013

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