Diabetes mellitus type 1, Diabetes mellitus type 2 Self-monitoring of blood glucose E10-E14
Conditions
Interventions
Group 1: Male or female, with Diabetes mellitus type 1, Diabetes mellitus type 2 or subjects without diabetes (=18 years)
Measurement of blood glucose in capillary blood samples
in addition, pO2, oxygen saturation and hemoglobin of the capillary blood sample and the blood’s hematocrit value will be determined. Study personnel will collect a capillary blood sample from the sub
Sponsors
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT); Dr. med. Guido Freckmann
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Type 1 diabetes, type 2 diabetes or subjects without diabetes; Signed informed consent form; Subjects are legally competent and capable to understand character, meaning and consequences of the study; In order to ensure that capillary blood samples meet the requirements indicated in the manufacturer’s labelling, a physician will review the subjects’ anamnesis and medication and check for interfering substances indicated in the manufacturer’s labelling; and the hematocrit value of each subject will be checked to be within the range indicated in the manufacturer’s labelling
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of pO2 influences on SMBG measurements (primary outcome: systematic blood glucose measurement deviations; measurement method: blood glucose measurements with blood glucose monitoring systems and determination of pO2. For each subject, the measurements will be performed during the visit at the study site (approximately 2 hours). For this purpose, for each subject and each SMBG system: Calculation of mean and standard deviation (SD) of the 6 measurements; Calculation of the bias between the GOD-based BGMS’ mean values and the GDH-based BGMS’ mean value for each sample. The difference in bias between samples with the most extreme pO2 values will be calculated to estimate the pO2 influence | — |
Secondary
| Measure | Time frame |
|---|---|
| no secondary outcome | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT)
Outcome results
None listed