NCT03405415|Completed
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Sponsor study identifier
interventional
41
1 country
1
Study Start
January 27, 2018
Actual (reported)Primary Completion
July 10, 2019
Actual (reported)Study Completion
July 10, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 12, 2018
Actual (reported)January 23, 2018
Actual (reported)January 27, 2018
Actual (reported)July 10, 2019
Actual (reported)July 10, 2019
Actual (reported)Assessment of glucose concentrations
14 days per subject
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
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.
Guido Freckmann, MD
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
41 participants (actual enrollment reported by the registry).
First Submitted
January 12, 2018
First Posted
January 23, 2018
Study Start
January 27, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 10, 2019
Actual (reported)Study Completion
July 10, 2019
Actual (reported)Last Updated
July 28, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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