A Twelve-Week Pilot Study Evaluating the Usability and Preliminary Effects of SugarVita 2.0 in Adults With Type 2 Diabetes
ID: NCT07812623
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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.
Read Full Scientific Objectives & Methods
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
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
Treatment Arms Description
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.
- 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
- Pregnancy or breastfeeding
- Active malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
Primary Outcome Measures
- Change in diabetes self-confidence measured using the Confidence in Diabetes Self-Care Scale (VDZ) — Time Frame: 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) — Time Frame: 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 — Time Frame: 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) — Time Frame: 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.
View Secondary Outcome Measures (5)
- Change in HbA1c — Time Frame: 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) — Time Frame: 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 — Time Frame: 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 — Time Frame: 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 — Time Frame: During the 12-week intervention
The total number of SugarVita 2.0 gameplay sessions per participant will be automatically recorded during the intervention.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- 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.PubMed ↗
- 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.PubMed ↗
View Official Medical/Scientific Title
SugarVita 2.0: Confirmation of a Serious Game for Self-management of Diabetes