Institut Fuer Diabetes-Technologie Surveillance Program

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Status

Completed

Conditions

Diabetes

Treatments

Device: Blood glucose monitoring systems for self-testing

Study type

Interventional

Funder types

Other

Identifiers

NCT03737188

IDT-1722-IU

Details and patient eligibility

About

Assessment of the system accuracy of different blood glucose monitoring systems available in Europe

Full description

A variety of blood glucose monitoring systems (BGMS) are available on the European market. For many of these BGMS, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. The IDT surveillance program aims at assessing the system accuracy of different BGMS that are available in Europe in a manufacturer-independent, investigator-initiated study. The initial study will cover 18 BGMS from 18 different manufacturers. Per BGMS, one test strip lot will be assessed based on procedures stated in the international standard ISO 15197:2013 / EN ISO 15197:2015.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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