Recruiting

A Twelve-Week Pilot Study Evaluating the Usability and Preliminary Effects of SugarVita 2.0 in Adults With Type 2 Diabetes

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…

ClinicalTrials.gov IDNCT07812623

PhaseNA

Enrollment30

SponsorMaxima Medical Center

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Diabetes Mellitus, Diabetes Mellitus Type 2

About this study

Interventions

Behavioral: SugarVita 2.0 — 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

Primary outcomes

Change in diabetes self-confidence measured using the Confidence in Diabetes Self-Care Scale (VDZ) (Baseline and Week 12)
Change in diabetes self-management measured using the Diabetes Management Self-Efficacy Scale (DMSES) (Baseline and Week 12)
Change in diabetes-related distress measured using the Problem Areas in Diabetes (PAID) scale (Baseline and Week 12)
Change in diabetes-related knowledge measured using the Michigan Diabetes Knowledge Test (DKT) (Baseline and Week 12)

Eligibility information

Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy or breastfeeding * Active malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin

Study locations

Maxima Medical Centre, Eindhoven, North Brabant 5631 BM Netherlands

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.