System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus

Diabetes Clinical Trial

Official title:

EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290067
• Other study ID #: OPM-G-V-1203
• Secondary ID: IDT-1340-BE
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: December 19, 2014
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with type 1 or type 2 diabetes and healthy subjects

• Signed and dated informed consent form

• For small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)

Exclusion Criteria:

• Pregnancy or lactation period

• Severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test

• Mental incapacity or language barriers precluding adequate compliance with the test procedures

• Severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test

• Legal incompetence or limited legal competence

• Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)

• For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems

• For system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Device:
• Blood glucose monitoring system (Omnitest 3)

• Blood glucose monitoring system (Omnitest 5)

• Blood glucose monitoring system (Omnitest 5D)

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft	ULM

Sponsors (2)

Lead Sponsor	Collaborator
B. Braun Melsungen AG	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment		up to 6 hours
Primary	User performance of blood glucose monitoring systems indicated by patient [questionnaire]		up to 4 hours