Investigation of the influence of the partial pressure of oxygen in capillary blood on SMBG measurements

Not Applicable

• Conditions: Diabetes mellitus; Diabetes mellitus type 1, Diabetes mellitus type 2Self-monitoring of blood glucose; E10-E14

• Registration Number: DRKS00014229
• Lead Sponsor: Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT); Dr. med. Guido Freckmann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-07
• Study Completion: 2018-03-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of pO2 influences on SMBG measurements<br>(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). <br>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.<br>The difference in bias between samples with the most extreme pO2 values will be calculated to estimate the pO2 influence<br>

Secondary Outcome Measures

Name	Time	Method
no secondary outcome