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

Sponsors

Lead Sponsor: Medtronic Diabetes R&D Denmark

Source Medtronic Diabetes R&D Denmark
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.

Overall Status Unknown status
Start Date March 2013
Primary Completion Date July 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Accuracy endpoint 5 months
Safety endpoint 5 months
Secondary Outcome
Measure Time Frame
Accuracy endpoint 5 months
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: Integrated sensor and infusion set.

Arm Group Label: Integrated sensor and infusion set.

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ulrik Pedersen-Bjergaard, MD Principal Investigator Hilleroed Hospital
Overall Contact

Last Name: Ulrik Pedersen-Bjergaard, MD

Email: [email protected]

Location
Facility: Contact: Investigator:
Fredericia Hospital | Fredericia, 7000, Denmark Hans Gjessing, MD [email protected] Hans Gjessing, MD Principal Investigator
Hilleroed Hospital | Hilleroed, 3400, Denmark Ulrik Pedersen-Bjergaard, MD [email protected] Ulrik Pedersen-Bjergaard, MD Principal Investigator
Hvidovre Hospital | Hvidovre, 2650, Denmark Kirsten Norgaard, MD [email protected] Kirsten Noergaard, MD Principal Investigator
Location Countries

Denmark

Verification Date

January 2013

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Integrated sensor and infusion set.

Type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov