Assessment of Blood Glucose Monitoring Systems

Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01909687

Enrollment

163

Registered

2013-07-26

Start date

2013-07-31

Completion date

2013-12-31

Last updated

2015-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

blood glucose monitoring systems, ISO 15197, system accuracy

Brief summary

System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013

Interventions

DEVICEBlood glucose monitoring systems

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 18 years of age or older * Male or female subjects with type 1 or type 2 diabetes or healthy subjects * For BG adjustment people with type 1 diabetes

Exclusion criteria

* Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient * Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient * Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study * For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness * Legal incompetence or limited legal competence * Age \< 18 years * Dependency from the sponsor or the clinical investigator * Mental incapacity or language barriers precluding adequate compliance with the study procedures

Design outcomes

Primary

Measure	Time frame
Analysis of system accuracy	for each subject, the experimental phase has an expected duration of up to 6 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026