Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life

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

Status

Completed

Conditions

Subjects Without Diabetes Mellitus

Assessment of Glucose Concentrations

Treatments

Device: Blood glucose monitoring system and continuous interstitial glucose monitoring system

Study type

Interventional

Funder types

Other

Identifiers

NCT03405415

IDT-1623-IU

Details and patient eligibility

About

Participants will perform blood glucose monitoring (BGM) over the course of 14 days and, in parallel, wear continuous glucose monitoring (CGM) systems. Because current CGM systems typically achieve a lower level of analytical accuracy than BGM systems, participants will perform at least 5 blood glucose (BG) measurements per day. In addition, CGM systems are used to obtain minimally-invasive high-frequency glucose measurements to fill the gaps between BG measurements.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

At least 18 years of age
Written informed consent
Subject is legally competent and has the capacity to understand character, meaning and consequences of the study
Subject is willing to refrain from intake of salicylic acid and ascorbic acid and medication and/or compounds containing these substances

Exclusion criteria

Anamnestically known diabetes mellitus
Severe acute or chronic disease with potential risk of being adversely affected by the study 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)
Pregnancy or lactation period
Known severe skin reactions to adhesives
Blood donation within the previous two months (according to the subject's statement)
Language or other barriers potentially compromising an adequate compliance with study procedures