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Diabetes Mellitus, Type 2NCT06392178

SugarVita: a Digital Board Game

A study testing SugarVita in people with Diabetes Mellitus, Type 2, run by Maxima Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The serious digital game, SugarVita, is a collaborative effort between the Máxima Medical Centre (MMC) and Eindhoven University of Technology (TUe), intending to enhance self-management for individuals with diabetes. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
SugarVita
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteNetherlands
Study dates
1 Apr 2024to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Informed consent obtained before trial related activities
  • Diagnosed with T2DM
  • HbA1c levels > 64 mmol/mol (before start of study)
  • BMI > 25 kg/m2
  • Age above 18 years
  • Patient's language skills are sufficient for participation
  • Subject has a smartphone or tablet and is willing to install the needed application on it

Who cannot join

  • Pregnancy or breastfeeding women
  • Malignancy except basal and squamous cell skin cancer

Trial locations and contacts

1 site in 1 country.

Edouard Reinders, MD contact

0031408886300

edouard.reinders@mmc.nl

Pleun Wouters, PhD contact

0031408886300

Pleun.van.poppel@mmc.nl

Netherlands1 site, 1 recruiting
  • Maxima Medical Centre

    Eindhoven, North Brabant, 5631 BM

    Edouard Reinders, MD

    Recruiting

Other trials in Netherlands

About this study

Official title: SugarVita: an Educative Digital Board Game for Self-management in Diabetes

The serious digital game, SugarVita, is a collaborative effort between the Máxima Medical Centre (MMC) and Eindhoven University of Technology (TUe), intending to enhance self-management for individuals with diabetes. As a mobile application available on smartphones and tablets, SugarVita emerged from cooperative design sessions involving patients diagnosed with diabetes. The average age of type 2 diabetes patients in the Netherlands exceeds 50 years. Following extensive discussions with these patients, the decision was made to model SugarVita after a digital board game, reminiscent of the classic board game 'ganzenbord' (Game of the Goose). In SugarVita, players experience a day in the life of an individual with diabetes, making choices regarding dietary habits, physical activity, and medication intake. Throughout this simulated day, the blood glucose level serves as a central theme. Players earn points by effectively managing their blood glucose levels. SugarVita can be played together with relatives or friends. The game aims to give people with diabetes more control over their chronic condition. Self-care is now seen as the primary approach to diabetes, which is a complex multi-faceted task where training and education are crucial. Importantly, SugarVita recognizes that a conventional 'dry' explanation may not resonate with everyone.

Read the detailed description

The majority of diabetes mellitus patients in the Netherlands are aged 50 and above, predominantly diagnosed with type 2 diabetes mellitus. Patient education in this context primarily occurs through consultations with healthcare professionals such as general practitioners, internists, and diabetes nurses. However, these interactions alone may not comprehensively address the complexities associated with managing a chronic condition like diabetes. Consequently, self-education constitutes a crucial role in empowering patients to cope with their disease. In response to this need, the investigators have developed SugarVita, a serious game designed to facilitate patient training and skill development in diabetes regulation within the comfort of their homes through playful learning.

Previous studies have indicated that serious diabetes games can enhance patient self-management, potentially leading to controlled or reduced healthcare costs, although the impact on HbA1c levels is often modest. SugarVita distinguishes itself by visualizing the short-term effects of a player's decisions on their glycemic levels and providing rewards for healthy and appropriate choices. The ultimate goal is to encourage the cultivation of health-promoting behaviors in daily life.

SugarVita adopts the format of a digital board game, akin to the Game of the Goose, where players progress through the board by rolling a dice. The SugarVita board comprises a circular arrangement of tiles, mirroring a full day (24 hours), with each tile representing a 20-minute interval. Players traverse the day, encountering various events such as meals, activities, and emotional experiences, all presented in a digital gaming format. The board features distinct pathways corresponding to workdays, outdoor days, and leisure days. Players enter the game through a personalized setup facilitated by the simulator. The primary objective for players is to maintain their glucose levels within a safe range, and therefore earn points by doing so. While immersed in the game, players assume the perspective of an individual with diabetes, navigating the daily decisions inherent to the condition. In this interactive experience, players make choices regarding their food intake, engage in physical activities, and manage medication usage, including insulin doses. The repercussions of these decisions are reflected in the game through a visible glucose meter, dynamically responding to the player's actions. Points are awarded when the glucose meter remains within the target range, creating a learning environment through gameplay and direct feedback. The player achieving the highest score emerges as the winner.

The multiplayer aspect of SugarVita allows patients with diabetes to engage in the game alongside their relatives, fostering discussions about the diverse choices made during gameplay. This collaborative approach enhances mutual understanding of a relative's condition, providing additional support. The unique multiplayer feature of SugarVita distinguishes it from other diabetes games. Involving the social network of patients can potentially contribute to the development of healthier habits.

Designed for the largest segment of diabetes patients, namely young seniors aged 50 to 75 with type 2 diabetes, SugarVita targets lifestyle and habit changes crucial for disease management. Our clinical experience underscores the challenges these patients face in altering their habits and understanding the intricacies of glucose level regulation. Within the young senior demographic, considerable variations exist, including differences in educational attainment and attitudes towards personal health. Some individuals may be illiterate and display minimal concern for their health, while others are motivated to initiate positive changes. Recognizing these differences, the investigators adopted varied approaches to appeal to distinct patient types. Target group interviews further revealed that our audience enjoys board games, expresses openness to digital games, and prefers playing on tablets or mobile phones. While our primary focus is on young senior type 2 patients, SugarVita aims to be appealing to a broader audience, including other diabetes patients, their relatives, and caregivers.

Being tested
SugarVita
Keywords
gamification, mHealth, self-management, diabetes type 2
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SugarVitaDevice

    Serious digital game (application) that can be played on mobile phone, tablet or personal computer. Self-developed game.

Study groups in NCT06392178
Study groupRoleWhat they receive
SugarVitaExperimentalParticipants in the intervention group will download and play the app SugarVita on their mobile phone or tablet, or they can borrow a tablet from the research group. All participants are requested to fill in questionnaires concerning diabetes related topics at the start of the study, and after 8 weeks
Receives: Device: SugarVita
Standard careNo interventionParticipants in the control group will receive standard care, the usual care that is being given at the outpatient clinic. All participants are requested to fill in questionnaires concerning diabetes related topics at the start of the study, and after 8 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the impact of SugarVita on self-management

    This will be measured by filling in the Diabetes Management Self-Efficacy Scale (DSMES) at the beginning of the study (week 1) and at the end (week 8). This is a dutch validated questionnaire consisting of 20 questions. A higher score indicates a higher estimated level of self-management.

    Measured: 8 weeks

  2. To assess the impact of SugarVita on self-confidence

    This will be measured by filling in the 'Confidence in Diabetes Self-car Scale' questionnaire at the beginning of the study (week 1) and at the end (week 8). This is a dutch validated questionnaire consisting of 20 questions. A higher score indicates a higher estimated level of self-confidence.

    Measured: 8 weeks

  3. To assess the impact of SugarVita on diabetes related knowledge

    This will be measured by filling in a self created dutch questionnaire concerning questions about diabetes knowledge. This questionnaire will be filled in at the beginning of the study (week 1) and at the end (week 8). This self-developed questionnaire consisting of 19 questions. A higher score indicates a higher estimated level of diabetes related knowledge.

    Measured: 8 weeks

Secondary outcomes (3)
  1. To evaluate the patients perception on SugarVita and the usage of using digital games as an educational tool

    This will be assed by a self-made questionnaire concerning 11 questions. Participants in the SugarVita group will fill in this questionnaire at the end of the study. Participants in the regular care group do not fill in this questionnaire.

    Measured: 8 weeks

  2. To gather data from player performances in SugarVita (how long do participants play SugarVita in minutes)

    This data will be collected automatically if participants log into their SugarVita account

    Measured: 8 weeks

  3. To gather data from player performances in SugarVita (how many times do they log into the game, frequency will be measured)

    This data will be collected automatically if participants log into their SugarVita account

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06392178
Sponsor's protocol ID
N24.020.
Status last verified
Apr 2024
First submitted
10 Apr 2024
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing SugarVita in people with Diabetes Mellitus, Type 2, run by Maxima Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Edouard Reinders, MD (0031408886300, edouard.reinders@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the impact of SugarVita on self-management (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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