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NCT Number: NCT07812623

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, HbA1c, and user engagement in adults with type 2 diabetes.

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maxima Medical Centre

Eindhoven, North Brabant, 5631 BM, Netherlands

Location status: Recruiting

Location contact

Dr. Pleun Wouters- van Poppel, MSc

CONTACT

[email protected]

+31 (0)40 888 6300

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SugarVita 2.0

Behavioral

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Pleun Wouters-van Poppel, PhD

CONTACT

[email protected]

+31 (0)40 888 6300

Edouard Reinders, MSc

CONTACT

[email protected]

+31 (0)40 888 6300

Sponsors and collaborators

Lead sponsor

Maxima Medical Center

Other

Registry information

Official study title

SugarVita 2.0: Confirmation of a Serious Game for Self-management of Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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