NCT07812623

Brief Summary

Diabetes self-management education is essential for achieving optimal glycemic control, but conventional education does not meet the needs of all patients. SugarVita 2.0 is a serious digital game designed to improve diabetes self-management through interactive gameplay and a semi-personalized glucose simulator. This multicenter, single-arm, 12-week pilot study will evaluate the usability of SugarVita 2.0 and its effects on diabetes self-management, self-confidence, diabetes-related distress, diabetes knowledge, HbA1c, and user engagement in adults with type 2 diabetes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
10mo left

Started Aug 2026

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 Progress17%
Aug 2026Aug 2027

First Submitted

Initial submission to the registry

August 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

August 5, 2026

Last Update Submit

September 4, 2026

Conditions

Diabetes MellitusDiabetes Mellitus Type 2

Keywords

Diabetes mellitusdigital interventionserious gameeducationadults with diabetesDiabetes type 2

Outcome Measures

Primary Outcomes (4)

  • Change in diabetes self-confidence measured using the Confidence in Diabetes Self-Care Scale (VDZ)

    Diabetes self-confidence will be assessed using the Dutch version of the Confidence in Diabetes Self-Care Scale (CIDS), known in Dutch as the Vertrouwen in Diabetes Zelfzorg (VDZ) questionnaire. The questionnaire consists of 21 items assessing confidence in performing diabetes self-care activities. Each item is scored from 1 to 5, resulting in a total score ranging from 21 to 105. Higher scores indicate greater confidence in diabetes self-care. Change from baseline to Week 12 will be assessed.

    Baseline and Week 12

  • Change in diabetes self-management measured using the Diabetes Management Self-Efficacy Scale (DMSES)

    Diabetes self-management self-efficacy will be assessed using the validated Dutch version of the Diabetes Management Self-Efficacy Scale (DMSES). The DMSES consists of 20 items scored from 0 to 10, resulting in a total score ranging from 0 to 200. Higher scores indicate greater self-efficacy in diabetes self-management. Change from baseline to Week 12 will be evaluated.

    Baseline and Week 12

  • Change in diabetes-related distress measured using the Problem Areas in Diabetes (PAID) scale

    Diabetes-related distress will be assessed using the Problem Areas in Diabetes (PAID) scale. The PAID consists of 20 items scored from 0 to 4. The summed score is multiplied by 1.25, resulting in a total score ranging from 0 to 100. Higher scores indicate greater diabetes-related emotional distress. Change from baseline to Week 12 will be evaluated.

    Baseline and Week 12

  • Change in diabetes-related knowledge measured using the Michigan Diabetes Knowledge Test (DKT)

    Diabetes-related knowledge will be assessed using the Michigan Diabetes Knowledge Test (DKT). The questionnaire assesses knowledge of diabetes and its self-management. The total score is based on the number of correctly answered items, with higher scores indicating greater diabetes-related knowledge. Change from baseline to Week 12 will be evaluated.

    Baseline and Week 12

Secondary Outcomes (5)

  • Change in HbA1c

    Baseline and Week 12

  • Change in Time in Range (if available)

    Baseline and Week 12

  • User evaluation of SugarVita 2.0

    Week 12

  • Total SugarVita 2.0 gameplay duration

    During the 12-week intervention

  • Number of SugarVita 2.0 gameplay sessions

    During the 12-week intervention

Study Arms (1)

SugarVita 2.0

EXPERIMENTAL

Participants will receive access to SugarVita 2.0 and will use the serious game during a 12-week intervention period. During the first six weeks participants are instructed to play at least three times per week and complete predefined weekly challenges. During weeks 7-10 participants play at least twice weekly without predefined challenges, followed by two weeks of unrestricted use. Questionnaires and routine clinical data are collected before and after the intervention.

Behavioral: SugarVita 2.0

Interventions

SugarVita 2.0BEHAVIORAL

SugarVita 2.0 is a serious digital educational game designed to improve diabetes self-management. Players make decisions regarding nutrition, physical activity and diabetes medication while receiving direct visual feedback through a semi-personalized glucose simulator. The game is intended to increase diabetes-related knowledge, self-management skills and self-confidence through interactive learning and repeated gameplay

SugarVita 2.0

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or older
  • Diagnosis of type 2 diabetes mellitus (T2DM)
  • Written informed consent obtained before any study procedures
  • HbA1c \>55 mmol/mol prior to study participation
  • For participants with T2DM only: BMI \>25 kg/m²
  • Sufficient command of the Dutch language to complete study questionnaires

You may not qualify if:

  • Pregnancy or breastfeeding
  • Active malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maxima Medical Centre

Eindhoven, North Brabant, 5631 BM, Netherlands

RECRUITING

Related Publications (2)

  • Duraiswami R, Kalghatgi AT, Kumaravelu S. MENINGEAL ASPERGILLOSIS (A Case Report). Med J Armed Forces India. 1997 Oct;53(4):313-314. doi: 10.1016/S0377-1237(17)30766-9. Epub 2017 Jun 26. No abstract available.

    PMID: 28769524BACKGROUND

  • Maas AH, van der Molen P, van de Vijver R, Chen W, van Pul C, Cottaar EJ, van Riel NA, Hilbers PA, Haak HR. Concept Development of the Eindhoven Diabetes Education Simulator Project. Games Health J. 2016 Apr;5(2):120-7. doi: 10.1089/g4h.2015.0037. Epub 2016 Feb 12.

    PMID: 26871654BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pleun Wouters - van Poppel, MSc

    Maxima Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Pleun Wouters-van Poppel, PhD

CONTACT

+31 (0)40 888 6300pleun.van.poppel@mmc.nl

Edouard Reinders, MSc

CONTACT

+31 (0)40 888 6300edouard.reinders@mmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All enrolled participants receive the SugarVita 2.0 serious game intervention for 12 weeks. Participants with diabetes are analyzed as predefined subgroups, but all receive the same intervention without randomization or a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2026

First Posted

September 10, 2026

Study Start

August 5, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made publicly available because the study was not designed with participant-level data sharing in mind and participant confidentiality cannot be sufficiently safeguarded in this relatively small pilot study. Researchers may contact the principal investigator to discuss reasonable requests for aggregated study data or additional information.

Locations

NL(1)