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

Assessment of Glucose Concentrations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405415
• Other study ID #: IDT-1623-IU
• Status: Completed
• Phase: N/A
• Start date: January 27, 2018
• Est. completion date: July 10, 2019

Study information

• Verified date: July 2022
• Source: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Assessment of Glucose Concentrations
• Diabetes Mellitus
• Subjects Without Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Ulm	Baden-Württemberg

Sponsors (1)

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

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. 2022 Jul 25:19322968221113341. doi: 10.1177/19322968221113341. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of glucose concentrations		14 days per subject