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

B. Braun

Status

Terminated

Conditions

Diabetes

Treatments

Device: Blood glucose monitoring system (Omnitest 5)

Device: Blood glucose monitoring system (Omnitest 3)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02439177

OPM-G-V-1503

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.