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

NCT ID: NCT02439177

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-05-31

Brief 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.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Omnitest 3

Blood glucose monitoring system

Group Type: EXPERIMENTAL

Blood glucose monitoring system (Omnitest 3)

Intervention Type: DEVICE

Omnitest 5

Blood glucose monitoring system

Group Type: EXPERIMENTAL

Blood glucose monitoring system (Omnitest 5)

Intervention Type: DEVICE

Interventions

Blood glucose monitoring system (Omnitest 3)

Intervention Type: DEVICE

Blood glucose monitoring system (Omnitest 5)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: collaborator

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Ulm, , Germany

Countries

Germany

Other Identifiers

OPM-G-V-1503

Identifier Type: -

Identifier Source: org_study_id