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

Diabetes Mellitus Type II Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01775059
• Other study ID #: CEP 277
• Secondary ID: 2012102304
• Status: Not yet recruiting
• Phase: N/A
• First received: January 21, 2013
• Last updated: February 4, 2013
• Start date: March 2013

Study information

• Verified date: January 2013
• Source: Medtronic Diabetes R&D Denmark
• Contact: Ulrik Pedersen-Bjergaard, MD
• Email: ulrik.pedersen-bjergaard[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type I
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Device:
• Integrated sensor and infusion set.

Locations

Country	Name	City	State
Denmark	Fredericia Hospital	Fredericia
Denmark	Hilleroed Hospital	Hilleroed
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes R&D Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy endpoint	MARD(%), BIAS(mg/dl), MAD(mg/dl) during study	5 months	No
Primary	Accuracy endpoint	Agreement Rate (% within 20%) using VEO Pump	5 months	No
Primary	Safety endpoint	Descriptive summary of SAE, Adverse events and Device complaints	5 months	Yes
Secondary	Accuracy endpoint	Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data	5 months	No