Trial document




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  DRKS00014229

Trial Description

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Title

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

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Trial Acronym

IDT-1348-IU

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The objective of this study is the investigation of possible influences of the partial pressure of oxygen (pO2) in the capillary blood sample on measurements with glucose oxidase-(GOD-) based systems for self-monitoring of blood glucose (SMBG). For this purpose two SMBG systems will be used exemplarily which showed marked pO2 influence in previous studies; whilst being only labeled to be sensitive to increased blood oxygen content.
Study personnel will collect a capillary blood sample from the subject’s fingertip by skin puncture and blood glucose measurements will be performed with the two GOD-based systems (6 meters per system with 1 test strip lot) and the GDH-based system and a laboratory measurement method. In addition, pO2, oxygen saturation and hemoglobin of the capillary blood sample and the blood’s hematocrit value will be determined. Subjects will be recruited from the study site’s database with the aim of covering a wide pO2 range

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Brief Summary in Scientific Language

In this study, influence of pO2 on measurement results will be investigated for glucose oxidase-(GOD-) SMBG systems. For this purpose two SMBG systems will be used exemplarily that showed marked pO2 influence in previous studies, whilst being only labeled to be sensitive to increased blood oxygen content. A glucose dehydrogenase- (GDH-) based SMBG system will be included in the investigation as pO2-independent comparison system and for the verification of sample stability.

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Organizational Data

  •   DRKS00014229
  •   2018/03/07
  •   [---]*
  •   yes
  •   Approved
  •   MP-2015-009, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   Diabetes mellitus type 1, Diabetes mellitus type 2
  •   Self-monitoring of blood glucose
  •   E10-E14 -  Diabetes mellitus
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Interventions/Observational Groups

  •   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 subject’s fingertip by skin puncture. Study duration per subject: 1 visit at the study site for approximately 2 hours
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

no secondary outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/03/05
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT); Dr. med. Guido Freckmann
    • Helmholtzstraße 20
    • 89081  Ulm
    • Germany
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    • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT)
    • Ms.  Dr. biol. hum.  Annette  Baumstark 
    • Helmholtzstraße 20
    • 89081  Ulm
    • Germany
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    • Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IDT)
    • Mr.  Dr. med.  Guido  Freckmann 
    • Helmholtzstraße 20
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Roche Diabetes Care GmbH
    • Sandhofer Straße 116
    • 68305  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/20
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.