Feasibility Study - Integrated Sensor and Infusion Set. T... | NCT01773668

Studies
Feasibility Study - Integrated Sensor and Infusion Set. Trial III

NCT01773668

Sponsor

Medtronic Diabetes R&D Denmark

Status

Completed

Last Update Posted

Feb 5, 2013Estimated

Enrollment

17Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes
Type 2 Diabetes

Interventions

Integrated sensor and infusion set.

Countries

Sweden

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

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Oct 31, 2012

First Submission Date that Met QC Criteria

Jan 18, 2013

First Posted Date

Jan 23, 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

The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.

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

17Actual

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
Performance data	The purpose of this study is to collect performance data on the integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities.	4 months

Secondary Outcomes

Measure	Description	Time Frame
Performance characteristics	Comparative analysis of performance characteristics of the sensors of the Integrated sensor and infusion set with the Enlite sensors will be performed. SMBG data will be used as reference.	4 months
Functionality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 21-70 years of age at time of screening (age criteria chosen in order to comply with other studies in the same field of research).
Subject has a clinical diagnose of type 1 or type 2 diabetes, as determined by investigator.
Subject has one or more established insulin carbohydrate ratio.
Subject has one or more established insulin correction ratio.
Subject is a high bolus user (>10 units/meal) for at least one meal a day.
Subject is currently using a Medtronic insulin pump and has been so for a minimum of 3 months at time of enrollment.
Subject has been using insulin for more than one year.
Subject is willing to wear two pumps, one sensor, one infusion set and one Integrated sensor and infusion set at one time (first night).
Subject is willing to perform frequent SMBGs during Visits 3 and 4.
Subject is in good general health without other acute or chronic illnesses.

Exclusion Criteria:

Vulnerable population will not be included in the study
Subject is pregnant as per urine test or lactating (if female), as self-declared by patient.
Subject plans to become pregnant during the course of the study.
Subject is unable to tolerate tape adhesive in the area of sensor placement.
Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection).
The subject has complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months.
The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening or which might confound the collection or interpretation of the study data.
The subject has experienced two or more severe hypoglycemic events - seizures/coma requiring assistance in the past 6 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

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