NCT07257822

Brief Summary

Digital health tools may present an opportunity to address these challenges by enhancing care delivery, improving patient engagement, and facilitating better disease management for chronic diseases such as type 2 diabetes mellitus (T2DM). This primary objective of this randomized controlled trial is to evaluate whether the Diabetes Digital Patient Reminder (DIPAR), embedded in patient portal, can increase the proportion of T2DM patients who have their albuminuria measured at least once annually by either a general practitioner (GP) or a diabetes specialist, as documented in their hospital medical records (EMD), thereby reflecting active monitoring of diabetes-related parameters.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Oct 2025

Geographic Reach
1 country

2 active sites

Status
active not 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 Progress35%
Oct 2025Jun 2027

First Submitted

Initial submission to the registry

September 24, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

September 24, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

DiabetesType 2 Diabetes MellitusSelf-CareSelf-ManagementDigital InterventionMobile Health ApplicationJoint action on cardiovascular diseases and diabetesJACARDIThe Digital Diabetes Patient Reminder projectDIPAR

Outcome Measures

Primary Outcomes (1)

  • Documentation rate of Albuminuria

    Defining the proportion of patients with at least one measured and documented albuminuria value in the electronic medical dossier

    12 months post intervention

Secondary Outcomes (10)

  • Documentation rate of HbA1c (2x)

    12 month post intervention

  • Documentation rate of HbA1c (1x)

    12 month post intervention

  • DIPAR Usability

    12 months post intervention

  • DIPAR Acceptability

    12 months post intervention

  • Change in HbA1c

    Baseline, Month 6 and Month 12 post intervention

  • +5 more secondary outcomes

Study Arms (2)

DIPAR Intervention Group

EXPERIMENTAL

Standard of Care and the Digital DIPAR Intervention (reminder function + consultation dashboard)

Device: Digital Diabetes Patient Reminder ToolOther: Standard of Care treatment and follow-up

Control Group

OTHER

Standard of Care

Other: Standard of Care treatment and follow-up

Interventions

\- Reminder function: participants will receive reminders that align with the minimal follow-up requirements in Belgium, when the HbA1c and albuminuria measurements are overdue o Notification schedule: HbA1c: First reminder after 7 months without a measurement; second reminder 4 weeks later if still overdue. Albuminuria: First reminder after 13 months without a measurement; second reminder 4 weeks later if still overdue. \- Consultation dashboard: this feature will allow the display selected diabetes clinical parameters in a visual and colorful display. The selected parameters are: HbA1c (%), LDL-C (mg/dl), systolic and diastolic blood pressure (mmHg), albuminuria (mg/gACR), eGFR (ml/min/1.73m2) and BMI (weight/lenght2). Furthermore, participants will be provided with a questionnaire that targets selfcare behaviors and are required to complete this before consultations with their diabetes-specialist or general practitioner.

DIPAR Intervention Group

This allows for the control to group to receive only their routine consultation and follow-up care as provided by their diabetes specialist.

Control GroupDIPAR Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
  • Adults 18 years or older;
  • Treated and followed-up for Type 2 diabetes at the department of endocrinology at the participating hospitals;
  • Patients with (the ability to access) the MyNexuz patient portal;
  • Patients with the ability to understand Dutch, French or English.

You may not qualify if:

  • Participant is pregnant or hospitalized at the time of recruitment;
  • Are unable to use a mobile phone because of mental or cognitive impairment;
  • Deemed ineligible by the treating physicians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regional Hospital of Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

University Hospital of UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Roman Vangoitsenhoven, Prof Dr.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomization will be carried out by an external person to the study and the data will be analyzed by an external extension
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr., MD, PhD

Study Record Dates

First Submitted

September 24, 2025

First Posted

December 2, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations