Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

Diabetes Clinical Trial

Official title:

Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02439177
• Other study ID #: OPM-G-V-1503
• Status: Terminated
• Phase: N/A
• First received: April 30, 2015
• Last updated: August 20, 2015
• Start date: May 2015
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• 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 study is to determine the System Accuracy and User Performance evaluation of the mentioned BGM systems by gaining a sufficient amount of measured data from capillary blood.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects with type 1 or type 2 diabetes, for the evaluation of System Accuracy also healthy subjects

• Age = 18

• 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 - I.C.T.) or insulin pump therapy (continuous subcutaneous insulin infusion - C.S.I.I.)

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 subject caused by the test.

• 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 subject caused by the test.

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

• Legal incompetence or limited legal competence

• Dependency from the Sponsor or the clinical Investigator (e.g. co-workers of the Sponsor or the clinical research centre)

• For User Performance evaluation: Subjects having participated in a study with Omnitest® 5 before.

• 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

• Anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.

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)

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	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 7 hours	No
Primary	User Performance of blood glucose monitoring system indicated by patient		up to 7 hours	No