Diabetes MellitusDIABASENCT05584293
DIABASE; Diabetes Mellitus Registry in Second Care
An observational study of Diabetes Mellitus, run by Ziekenhuisgroep Twente at 1 site in Netherlands.
Trial summary
This study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Sep 2020to 31 Dec 2060
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with type 1 or type 2 diabetes mellitus. Patients are recruited at the outpatient clinic of internal medicine, diabetes clinic.
Who may be able to join
- Patients with type 1 or type 2 diabetes
- Patients aged 18 years or older
- Patients visiting the outpatient clinic internal medicine in the ZGT Hospital
- Written informed consent
Who cannot join
- Severe general diseases or mental disorders making the participation in the study impossible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Ziekenhuisgroep Twente
Almelo, Overijssel, 7609PP
Thomas Urgert, MSc, +31887083236, t.urgert@zgt.nl
Goos Laverman, prof. dr., +31887083079, g.laverman@zgt.nl
About this study
This study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Real world data from medical devices and clinical outcome in a registry
Examine real world data from medical devices and clinical outcome in a registry to gain the necessary insights to be able to improve individual patient care
Measured: 0-30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start11 Sep 2020
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2060 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Ziekenhuisgroep Twente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584293
- Sponsor's protocol ID
- ZGT20-40
- Other IDs
- W20.197
- Acronym
- DIABASE
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Urgert T, Kappert KDR, Veldhuis A, Geerdink J, van Beijnum BJF, Laverman GD. DIABASE: an automatically filled single-centre registry of diabetes mellitus in the Netherlands, combining clinical data with real-world longitudinal wearable device data-a study protocol. BMJ Open. 2025 Oct 13;15(10):e096888. doi: 10.1136/bmjopen-2024-096888.
PubMed 41083304den Braber N, Braem CIR, Vollenbroek-Hutten MMR, Hermens HJ, Urgert T, Yavuz US, Veltink PH, Laverman GD. Consequences of Data Loss on Clinical Decision-Making in Continuous Glucose Monitoring: Retrospective Cohort Study. Interact J Med Res. 2024 Jul 31;13:e50849. doi: 10.2196/50849.
PubMed 39083801
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIABASE; Diabetes Mellitus Registry in Second Care
- ClinicalTrials.gov ID
- NCT05584293
- Acronym / sponsor ID
- DIABASE / ZGT20-40
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ziekenhuisgroep TwenteUniversity, hospital or other
- Collaborators
- University of Twente
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2060 (estimated)
- First posted
- 18 Oct 2022 (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.
This study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with type 1 or type 2 diabetes mellitus. Patients are recruited at the outpatient clinic of internal medicine, diabetes clinic.
Key inclusion criteria (4 listed)
- Patients with type 1 or type 2 diabetes
- Patients aged 18 years or older
- Patients visiting the outpatient clinic internal medicine in the ZGT Hospital
- Written informed consent
Key exclusion criteria (1 listed)
- Severe general diseases or mental disorders making the participation in the study impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real world data from medical devices and clinical outcome in a registry
Time frame: 0-30 years
Examine real world data from medical devices and clinical outcome in a registry to gain the necessary insights to be able to improve individual patient care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 41083304Urgert T, Kappert KDR, Veldhuis A, Geerdink J, van Beijnum BJF, Laverman GD. DIABASE: an automatically filled single-centre registry of diabetes mellitus in the Netherlands, combining clinical data with real-world longitudinal wearable device data-a study protocol. BMJ Open. 2025 Oct 13;15(10):e096888. doi: 10.1136/bmjopen-2024-096888.
- Derived from this study: PubMed 39083801den Braber N, Braem CIR, Vollenbroek-Hutten MMR, Hermens HJ, Urgert T, Yavuz US, Veltink PH, Laverman GD. Consequences of Data Loss on Clinical Decision-Making in Continuous Glucose Monitoring: Retrospective Cohort Study. Interact J Med Res. 2024 Jul 31;13:e50849. doi: 10.2196/50849.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Ziekenhuisgroep Twente at 1 site in Netherlands.
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 1 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: looking for participants now, as of the sponsor's last update on 19 Apr 2024. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Urgert, MSc (+31887083236, t.urgert@zgt.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real world data from medical devices and clinical outcome in a registry (time frame: 0-30 years). 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 NCT05584293, which also lists 2 linked publications.
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 19 Apr 2024.