NCT05584293

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
422mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Sep 2020Dec 2060

Study Start

First participant enrolled

September 11, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
28.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2060

Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

30.3 years

First QC Date

October 13, 2022

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    0-30 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Severe general diseases or mental disorders making the participation in the study impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuisgroep Twente

Almelo, Overijssel, 7609PP, Netherlands

RECRUITING

Related Publications (2)

  • 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.

  • den 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Thomas Urgert, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 18, 2022

Study Start

September 11, 2020

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2060

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations