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

Study Overview
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Brief Summary
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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.

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

Conditions
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Subjects Without Diabetes Mellitus, Assessment of Glucose Concentrations

Intervention / Treatment
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* Device: Blood glucose monitoring system and continuous interstitial glucose monitoring system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Blood glucose monitoring system and continuous interstitial glucose monitoring system|At enrolment, participants are provided with BGM (Blood Glucose Monitoring) and CGM (Continuous Glucose Monitoring) systems. They will use the systems throughout the study. Participants will visit the study site three times. During the first visit, a standardized oral glucose tolerance test will be performed to ensure that participants do not have diabetes mellitus and to obtain glucose concentration data from people without diabetes mellitus during a glucose challenge. On another two days, participants will visit the study site for standardized breakfast and lunch meals to provide glucose concentration data under standardized conditions. Outside of the study site visits, participants are asked to eat similar meals on two days to obtain glucose concentration data under repeated conditions that represent daily life. During the study, participants are asked to document meals, physical activity and addition comments to provide context to the recorded glucose concentration data.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of glucose concentrations |  | 14 days per subject |