Subjects Without Diabetes MellitusNCT03405415
Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life
A study testing Blood glucose monitoring system and continuous interstitial glucose monitoring system in people with Subjects Without Diabetes Mellitus and Assessment of Glucose Concentrations, run by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm at 1 site in Germany.
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects Without Diabetes Mellitus, Assessment of Glucose Concentrations
- What is being tested?
- Blood glucose monitoring system and continuous interstitial glucose monitoring system
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2018to 10 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081
About this study
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.
- Being tested
- Blood glucose monitoring system and continuous interstitial glucose monitoring system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose monitoring system and continuous interstitial glucose monitoring systemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of glucose concentrations
Measured: 14 days per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start27 Jan 2018
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjects Without Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Freckmann, MD, Principal investigator, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405415
- Sponsor's protocol ID
- IDT-1623-IU
- Status last verified
- Jul 2022
- First submitted
- 12 Jan 2018
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35876145
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life
- ClinicalTrials.gov ID
- NCT03405415
- Acronym / sponsor ID
- IDT-1623-IU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität UlmUniversity, hospital or other
- Study start
- 27 Jan 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood glucose monitoring system and continuous interstitial glucose monitoring systemAt 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. | Device | – |
Primary outcome
Assessment of glucose concentrations
Time frame: 14 days per subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 35876145Freckmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Freckmann, MD principal investigator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose monitoring system and continuous interstitial glucose monitoring system in people with Subjects Without Diabetes Mellitus and Assessment of Glucose Concentrations, run by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of glucose concentrations (time frame: 14 days per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.