System accuracy evaluation of 4 blood glucose monitoring systems based on ISO 15197:2013 / EN ISO 15197:2015

Not Applicable

• Conditions: E14; Unspecified diabetes mellitus

• Registration Number: DRKS00028604
• Lead Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-22
• Study Completion: 2022-05-24
• Results First Posted: 2022-11-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Signed informed consent form
- Subjects 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 if venous samples are needed
- Severe acute disease that compromises the subject’s capability to participate in the study (at the study physician’s discretion)
- Severe chronic disease with potential risk during the test procedures (at the study physician’s discretion)
- Medical relevant anemia
- Suspected lack of compliance
- Dependence on investigator or sponsor
- If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy:
- Pregnancy or lactation period
- Subjects with type 1 diabetes, suffering from
- Coronary heart disease
- Condition after myocardial infarction
- Condition after cerebral events
- Peripheral arterial occlusive disease
- Hypoglycemia unawareness

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of measurement results within ±15 mg/dl (for blood glucose concentrations <100 mg/dl) or within ±15% (=100 mg/dl) of comparison measurement results

Secondary Outcome Measures

Name	Time	Method
Percentage of results within zones A and B of the Consensus Error Grid