Diabetes Mellitus, Diabetes Mellitus Type 2
Conditions
Keywords
Diabetes mellitus, digital intervention, serious game, education, adults with diabetes, Diabetes type 2
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.
Detailed description
SugarVita is a serious digital game developed through a collaboration between Máxima Medical Centre and Eindhoven University of Technology to support diabetes self-management. The game allows players to experience daily diabetes management by making decisions regarding nutrition, physical activity, and medication while receiving direct visual feedback on simulated glucose levels. SugarVita 2.0 incorporates a new semi-personalized glucose simulator intended to improve the educational experience. A previous pilot study evaluating the original version of SugarVita demonstrated improvements in diabetes-related knowledge, self-management, self-confidence, and HbA1c, with greater player engagement being associated with larger improvements. SugarVita 2.0 was developed to further improve the educational value and personalization of the intervention. This prospective, multicenter, single-arm pilot study will include 30 adults with diabetes. Participants will use SugarVita 2.0 during a 12-week intervention according to a predefined playing schedule. Diabetes self-management, self-confidence, diabetes-related distress, diabetes knowledge, HbA1c, and, where available, continuous glucose monitoring metrics will be assessed before and after the intervention. Gameplay characteristics, including playing time, frequency of use, and participant evaluation of the game, will also be collected to assess usability and user engagement
Interventions
BEHAVIORALSugarVita 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
Sponsors
Maxima Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in diabetes self-confidence measured using the Confidence in Diabetes Self-Care Scale (VDZ) | Baseline and Week 12 | 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) | Baseline and Week 12 | 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 | Baseline and Week 12 | 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) | Baseline and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline and Week 12 | 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) | Baseline and Week 12 | 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 | Week 12 | 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 | During the 12-week intervention | Total time spent playing SugarVita 2.0 will be automatically recorded during the intervention and reported in minutes. |
| Number of SugarVita 2.0 gameplay sessions | During the 12-week intervention | The total number of SugarVita 2.0 gameplay sessions per participant will be automatically recorded during the intervention. |
Countries
Netherlands
Contacts
CONTACTDr. Pleun Wouters-van Poppel, PhD
CONTACTEdouard Reinders, MSc
PRINCIPAL_INVESTIGATORPleun Wouters - van Poppel, MSc
Maxima Medical Center
Outcome results
None listed