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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405415
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subjects Without Diabetes Mellitus Assessment of Glucose Concentrations Device: Blood glucose monitoring system and continuous interstitial glucose monitoring system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life
Actual Study Start Date : January 27, 2018
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Intervention Details:
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of glucose concentrations [ Time Frame: 14 days per subject ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405415


Locations
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Germany
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Württemberg, Germany, 89081
Sponsors and Collaborators
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Investigators
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Principal Investigator: Guido Freckmann, MD Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
More Information
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Responsible Party: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
ClinicalTrials.gov Identifier: NCT03405415    
Other Study ID Numbers: IDT-1623-IU
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases