System Accuracy Evaluation of 6 CE-marked Blood Glucose Monitoring System Following ISO 15197:2013

NCT02531386 | Completed

• 1 other identifier: IDT-1525-BL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. In this study, system accuracy evaluation will be performed with CE-marked BGMS (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and Accu-Chek Mobile with three different reagent system lots for each BGMS. The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• System accuracy criteria (see description)

  System accuracy criteria Following ISO 15197:2013 (E), the BGMS shall meet both of the following criteria: Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \< 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). Each lot shall pass acceptability criterion A. Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. Applying ISO 15197:2003 accuracy criteria: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \< 75 mg/dl (4.2 mmol/l) or within ± 20 % at glucose concentrations ≥ 75 mg/dl (4.2 mmol/l).

  For each subject, the experimental phase has an expected duration of up to 6 hours

Interventions

6 blood glucose monitoring systems for self-testing (blood glucose meters) DEVICE

Also known as: Accu-Chek Aviva Nano, Accu-Chek Performa Nano, FreeStyle Lite, OneTouch Verio IQ, Contour Next Link 2.4, Accu-Chek Mobile

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 (concentration category 2):
• Coronary heart disease
• Condition after myocardial infarction
• Cerebral incidence
• Peripheral arterial occlusive disease

Sponsors & Collaborators

• Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm: lead
• Bayer: collaborator

Study Sites (1)

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

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Self-Testing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Self Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 24, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 9, 2015

Record last verified: 2015-09

Locations

DE (1)