Collection of Performance Data From the Integrated Sensor... | NCT01775059

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

NCT01775059

Sponsor

Medtronic Diabetes R&D Denmark

Status

Unknown status

Last Update Posted

Feb 5, 2013Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus Type I
Diabetes Mellitus Type II

Interventions

Integrated sensor and infusion set.

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012102304

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jul 2013Estimated

Completion Date

Not provided

First Submitted Date

Jan 21, 2013

First Submission Date that Met QC Criteria

Jan 23, 2013

First Posted Date

Jan 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2013

Last Update Posted Date

Feb 5, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Integrated sensor and infusion set.	Experimental		Device: Integrated sensor and infusion set.

Name	Type	Description	Arm Group Labels	Other Names
Integrated sensor and infusion set.	Device		Integrated sensor and infusion set.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Accuracy endpoint	Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data	5 months

Other Outcomes

Measure	Description	Time Frame
Accuracy endpoint	MARD(%), BIAS(mg/dl), MAD(mg/dl) during study	5 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ulrik Pedersen-Bjergaard, MD	Contact			ulrik.pedersen-bjergaard@regionh.dk

Name	Affiliation	Role
Ulrik Pedersen-Bjergaard, MD	Hilleroed Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Fredericia Hospital		Fredericia		7000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided