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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood glucose monitoring system and continuous interstitial glucose monitoring system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of glucose concentrations | 14 days per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Freckmann, MD | Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35876145 | Background | Freckmann G, Schauer S, Beltzer A, Waldenmaier D, Buck S, Baumstark A, Jendrike N, Link M, Zschornack E, Haug C, Pleus S. Continuous Glucose Profiles in Healthy People With Fixed Meal Times and Under Everyday Life Conditions. J Diabetes Sci Technol. 2024 Mar;18(2):407-413. doi: 10.1177/19322968221113341. Epub 2022 Jul 25. |
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