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

NCT03405415 | Completed

• 1 other identifier: IDT-1623-IU
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjects Without Diabetes Mellitus; Assessment of Glucose Concentrations

Outcome Measures

Primary Outcomes (1)

• Assessment of glucose concentrations

  14 days per subject

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm: lead

Study Sites (1)

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

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Related 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. 2024 Mar;18(2):407-413. doi: 10.1177/19322968221113341. Epub 2022 Jul 25.

  PMID: 35876145 BACKGROUND

Study Officials

• Guido Freckmann, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: January 27, 2018
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

DE (1)