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

Primary Purpose

Diabetes Mellitus Type I, Diabetes Mellitus Type II

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Integrated sensor and infusion set.
Sponsored by
Medtronic Diabetes R&D Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fredericia Hospital
  • Hilleroed Hospital
  • Hvidovre Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrated sensor and infusion set.

Arm Description

Outcomes

Primary Outcome Measures

Accuracy endpoint
Agreement Rate (% within 20%) using VEO Pump
Safety endpoint
Descriptive summary of SAE, Adverse events and Device complaints

Secondary Outcome Measures

Accuracy endpoint
Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data

Full Information

First Posted
January 21, 2013
Last Updated
February 4, 2013
Sponsor
Medtronic Diabetes R&D Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01775059
Brief Title
Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes R&D Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type I, Diabetes Mellitus Type II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated sensor and infusion set.
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Integrated sensor and infusion set.
Primary Outcome Measure Information:
Title
Accuracy endpoint
Description
Agreement Rate (% within 20%) using VEO Pump
Time Frame
5 months
Title
Safety endpoint
Description
Descriptive summary of SAE, Adverse events and Device complaints
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Accuracy endpoint
Description
Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Accuracy endpoint
Description
MARD(%), BIAS(mg/dl), MAD(mg/dl) during study
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrik Pedersen-Bjergaard, MD
Email
ulrik.pedersen-bjergaard@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Pedersen-Bjergaard, MD
Organizational Affiliation
Hilleroed Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fredericia Hospital
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Gjessing, MD
Email
hans.gjessing@slb.regionsyddanmark.dk
First Name & Middle Initial & Last Name & Degree
Hans Gjessing, MD
Facility Name
Hilleroed Hospital
City
Hilleroed
ZIP/Postal Code
3400
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrik Pedersen-Bjergaard, MD
Email
ulrik.pedersen-bjergaard@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ulrik Pedersen-Bjergaard, MD
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Norgaard, MD
Email
kirsten.noergaard@regionh.dk
First Name & Middle Initial & Last Name & Degree
Kirsten Noergaard, MD

12. IPD Sharing Statement

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

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