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

NCT01775059 | Unknown

• 2 other identifiers: CEP 2772012102304
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus Type I; Diabetes Mellitus Type II

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Accuracy endpoint

  5 months

Other Outcomes (1)

• Accuracy endpoint

  5 months

Study Arms (1)

Integrated sensor and infusion set.

EXPERIMENTAL

Device: Integrated sensor and infusion set.

Interventions

Integrated sensor and infusion set. DEVICE

Integrated sensor and infusion set.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Diabetes R&D Denmark: lead

Study Sites (3)

Fredericia Hospital

Fredericia, 7000, Denmark

Location

Hilleroed Hospital

Hilleroed, 3400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ulrik Pedersen-Bjergaard, MD

  Hilleroed Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrik Pedersen-Bjergaard, MD

CONTACT

ulrik.pedersen-bjergaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Last Updated: February 5, 2013

Record last verified: 2013-01

Locations

DK (3)