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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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.
Netherlands1 site, 1 recruiting
- Recruiting
Maxima Medical Centre
Eindhoven, North Brabant, 5631 BM
Edouard Reinders, MD
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.
- Conditions
- Diabetes Mellitus, Type 2
- 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 group | Role | What they receive |
|---|---|---|
| SugarVita | Experimental | Participants 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 care | No intervention | Participants 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.
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
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
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)
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
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
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.
- First posted30 Apr 2024
- Study start1 Apr 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edouard Reinders, Maxima Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SugarVita: an Educative Digital Board Game for Self-management in Diabetes
- ClinicalTrials.gov ID
- NCT06392178
- Acronym / sponsor ID
- N24.020.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- gamification, mHealth, self-management, diabetes type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SugarVita | Experimental | Device: SugarVitaParticipants 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 |
| Standard care | No intervention | –Participants 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding women
- Malignancy except basal and squamous cell skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugarVitaSerious digital game (application) that can be played on mobile phone, tablet or personal computer. Self-developed game. | Device | SugarVita |
Primary outcome
To assess the impact of SugarVita on self-management
Time frame: 8 weeks
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.
To assess the impact of SugarVita on self-confidence
Time frame: 8 weeks
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.
To assess the impact of SugarVita on diabetes related knowledge
Time frame: 8 weeks
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.
3 secondary outcomes
To evaluate the patients perception on SugarVita and the usage of using digital games as an educational tool
Time frame: 8 weeks
To gather data from player performances in SugarVita (how long do participants play SugarVita in minutes)
Time frame: 8 weeks
To gather data from player performances in SugarVita (how many times do they log into the game, frequency will be measured)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.