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
  Purpose

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 Intervention
Diabetes Mellitus Type I
Diabetes Mellitus Type II
Device: Integrated sensor and infusion set.

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

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes R&D Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Accuracy endpoint [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    MARD(%), BIAS(mg/dl), MAD(mg/dl) during study


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated sensor and infusion set. Device: Integrated sensor and infusion set.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medtronic Diabetes R&D Denmark
ClinicalTrials.gov Identifier: NCT01775059     History of Changes
Other Study ID Numbers: CEP 277, 2012102304
Study First Received: January 21, 2013
Last Updated: February 4, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on July 24, 2014