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

Not Applicable

Completed

• Conditions: Assessment of Glucose Concentrations; Subjects Without Diabetes Mellitus

• Registration Number: NCT03405415
• Lead Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-23
• Study Start: 2018-01-27
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of glucose concentrations	14 days per subject

Trial Locations

Locations (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany