Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Completed
NCT Number: NCT03405415
Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Blood glucose monitoring system and continuous interstitial glucose monitoring system
DeviceAt 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.
Primary outcomes
-
Assessment of glucose concentrations
Time frame: 14 days per subject
Sponsors and collaborators
Lead sponsor
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Other
Registry information
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jan 23, 2018
- Registry last updated
- Jul 28, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.