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.
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
Pregnancy or breastfeeding
Active malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
Single group
SugarVita 2.0
BehavioralSugarVita 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
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.
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.
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.
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.
Change in HbA1c
HbA1c values obtained as part of routine outpatient care will be collected from measurements performed up to 3 months before study start and up to 3 months after completion of the intervention.
Change in Time in Range (if available)
Time in Range derived from routine continuous glucose monitoring will be collected for participants using glucose sensors as part of standard clinical care.
User evaluation of SugarVita 2.0
Participants will rate their overall experience with SugarVita 2.0 using a study-specific evaluation questionnaire. The overall rating ranges from \[1\] to \[10\], with higher scores indicating a more positive evaluation.
Total SugarVita 2.0 gameplay duration
Total time spent playing SugarVita 2.0 will be automatically recorded during the intervention and reported in minutes.
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