User Performance Evaluation of Contour Plus, Accu-Chek Ac... | NCT02461394

Studies
User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013

NCT02461394

Sponsor

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Status

Completed

Last Update Posted

Jan 26, 2016Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Diabetes

Interventions

Blood glucose monitoring systems for self-testing

Countries

Germany

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

Status Module

Record Verification Date

Jan 2016

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

May 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Not provided

First Submitted Date

Jun 1, 2015

First Submission Date that Met QC Criteria

Jun 1, 2015

First Posted Date

Jun 3, 2015Estimated

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

Jan 25, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Name	Class
Bayer	INDUSTRY

Description Module

Brief Summary

The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch Select Simple (LifeScan) following ISO 15197:2013, clause 8.

The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.

For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.

The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Blood glucose monitoring systems for self-testing	Device			Contour Plus, Accu-Chek Active, Accu-Chek Performa, OneTouch Select Simple

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acceptance criteria defined by ISO 15197:2013 (see description)	95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations < 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).	For each subject, the experimental phase has an expected duration of up to 3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
Minimum age of 18 years
Signed informed consent form
Legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

Pregnancy or lactation period
Severe acute disease (at the study physician's discretion)
Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
Incapability of giving informed consent
< 18 years
Legally incompetent
Accommodated in an institution (e.g. psychiatric clinic)
Language barriers potentially compromising an adequate compliance with study procedures
Dependent from investigator or sponsor
For provoked blood glucose excursions 50 - 80 mg/dl:
Coronary heart disease
Condition after myocardial infarction
Cerebral incidence
Peripheral arterial occlusive disease
Hypoglycemia unawareness

Accepts Healthy Volunteers

Yes

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

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D012648	Self Care
D013812	Therapeutics