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

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ClinicalTrials.gov Identifier: NCT01775059
Recruitment Status : Unknown
Verified January 2013 by Medtronic Diabetes R&D Denmark.
Recruitment status was:  Not yet recruiting
First Posted : January 24, 2013
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes R&D Denmark

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type I Diabetes Mellitus Type II Device: Integrated sensor and infusion set. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2013
Estimated Primary Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Integrated sensor and infusion set. Device: Integrated sensor and infusion set.


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy endpoint [ Time Frame: 5 months ]
    Agreement Rate (% within 20%) using VEO Pump

  2. Safety endpoint [ Time Frame: 5 months ]
    Descriptive summary of SAE, Adverse events and Device complaints


Secondary Outcome Measures :
  1. Accuracy endpoint [ Time Frame: 5 months ]
    Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data


Other Outcome Measures:
  1. Accuracy endpoint [ Time Frame: 5 months ]
    MARD(%), BIAS(mg/dl), MAD(mg/dl) during study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775059


Contacts
Contact: Ulrik Pedersen-Bjergaard, MD ulrik.pedersen-bjergaard@regionh.dk

Locations
Denmark
Fredericia Hospital Recruiting
Fredericia, Denmark, 7000
Contact: Hans Gjessing, MD       hans.gjessing@slb.regionsyddanmark.dk   
Principal Investigator: Hans Gjessing, MD         
Hilleroed Hospital Recruiting
Hilleroed, Denmark, 3400
Contact: Ulrik Pedersen-Bjergaard, MD       ulrik.pedersen-bjergaard@regionh.dk   
Principal Investigator: Ulrik Pedersen-Bjergaard, MD         
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Kirsten Norgaard, MD       kirsten.noergaard@regionh.dk   
Principal Investigator: Kirsten Noergaard, MD         
Sponsors and Collaborators
Medtronic Diabetes R&D Denmark
Investigators
Principal Investigator: Ulrik Pedersen-Bjergaard, MD Hilleroed Hospital
More Information
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Responsible Party: Medtronic Diabetes R&D Denmark
ClinicalTrials.gov Identifier: NCT01775059     History of Changes
Other Study ID Numbers: CEP 277
2012102304
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases