Diabetes Clinical Trial
Official title:
Institut Fuer Diabetes-Technologie Surveillance Program for Blood Glucose Monitoring Systems in Europe
Assessment of the system accuracy of different blood glucose monitoring systems available in Europe
Status | Completed |
Enrollment | 126 |
Est. completion date | December 5, 2018 |
Est. primary completion date | December 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes - Signed informed consent form - Minimum age of 18 years - ubjects are legally competent and capable to understand character, meaning and consequences of the study. - If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy: - Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy. - Signature of subjects to document consent with these procedures on informed consent form. Exclusion Criteria: - 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) - Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) - Being unable to give informed consent - < 18 years - Legally incompetent - Being committed to an institution (e.g. psychiatric clinic) - Language barriers potentially compromising an adequate compliance with study procedures - Dependent on investigator or sponsor - If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from: - Coronary heart disease - Condition after myocardial infarction - Condition after cerebral events - Peripheral arterial occlusive disease - Hypoglycemia unawareness |
Country | Name | City | State |
---|---|---|---|
Germany | Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm | Ulm |
Lead Sponsor | Collaborator |
---|---|
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analysis of system accuracy based on ISO 15197 | Assessment of the analytical measurement performance of 18 blood glucose montoring systems based on procedures defined in ISO 15197 | For each subject, the experimental phase has an expected duration of up to 6 hours |
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