Diabetes MellitusNCT07812623
A Twelve-Week Pilot Study Evaluating the Usability and Preliminary Effects of SugarVita 2.0 in Adults With Type 2 Diabetes
A study testing SugarVita 2.0 in people with Diabetes Mellitus and Diabetes Mellitus Type 2, run by Maxima Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus Type 2
- What is being tested?
- SugarVita 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding
- Active malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maxima Medical Centre
Eindhoven, North Brabant, 5631 BM
Dr. Pleun Wouters- van Poppel, MSc, +31 (0)40 888 6300, pleun.van.poppel@mmc.nl
About this study
Official title: SugarVita 2.0: Confirmation of a Serious Game for Self-management of 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.
Read the 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
- Conditions
- Diabetes Mellitus, Diabetes Mellitus Type 2
- Being tested
- SugarVita 2.0
- Keywords
- Diabetes mellitus, digital intervention, serious game, education, adults with diabetes, Diabetes type 2
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugarVita 2.0Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| SugarVita 2.0 | Experimental | 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. Receives: Behavioral: SugarVita 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diabetes self-confidence measured using the Confidence in Diabetes Self-Care Scale (VDZ)
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.
Measured: Baseline and Week 12
Change in diabetes self-management measured using the Diabetes Management Self-Efficacy Scale (DMSES)
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.
Measured: Baseline and Week 12
Change in diabetes-related distress measured using the Problem Areas in Diabetes (PAID) scale
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.
Measured: Baseline and Week 12
Change in diabetes-related knowledge measured using the Michigan Diabetes Knowledge Test (DKT)
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.
Measured: Baseline and Week 12
Secondary outcomes (5)
Change in HbA1c
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.
Measured: Baseline and Week 12
Change in Time in Range (if available)
Time in Range derived from routine continuous glucose monitoring will be collected for participants using glucose sensors as part of standard clinical care.
Measured: Baseline and Week 12
User evaluation of SugarVita 2.0
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.
Measured: Week 12
Total SugarVita 2.0 gameplay duration
Total time spent playing SugarVita 2.0 will be automatically recorded during the intervention and reported in minutes.
Measured: During the 12-week intervention
Number of SugarVita 2.0 gameplay sessions
The total number of SugarVita 2.0 gameplay sessions per participant will be automatically recorded during the intervention.
Measured: During the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start5 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 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
- Investigators
- Pleun Wouters - van Poppel, MSc, Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812623
- Sponsor's protocol ID
- 2026.0306
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available because the study was not designed with participant-level data sharing in mind and participant confidentiality cannot be sufficiently safeguarded in this relatively small pilot study. Researchers may contact the principal investigator to discuss reasonable requests for aggregated study data or additional information.
Publications
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 28769524Maas 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 26871654
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SugarVita 2.0: Confirmation of a Serious Game for Self-management of Diabetes
- ClinicalTrials.gov ID
- NCT07812623
- Acronym / sponsor ID
- 2026.0306
- Conditions
- Diabetes Mellitus, Diabetes Mellitus Type 2
- Keywords
- Diabetes mellitus, digital intervention, serious game, education, adults with diabetes, Diabetes type 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| SugarVita 2.0 | Experimental | Behavioral: SugarVita 2.0Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding
- Active malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
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 |
|---|---|---|
| SugarVita 2.0SugarVita 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 | Behavioural | SugarVita 2.0 |
Primary outcome
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.
5 secondary outcomes
Change in HbA1c
Time frame: Baseline and Week 12
Change in Time in Range (if available)
Time frame: Baseline and Week 12
User evaluation of SugarVita 2.0
Time frame: Week 12
Total SugarVita 2.0 gameplay duration
Time frame: During the 12-week intervention
Number of SugarVita 2.0 gameplay sessions
Time frame: During the 12-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 28769524Duraiswami 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.
- Background: PubMed 26871654Maas 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available because the study was not designed with participant-level data sharing in mind and participant confidentiality cannot be sufficiently safeguarded in this relatively small pilot study. Researchers may contact the principal investigator to discuss reasonable requests for aggregated study data or additional information.
Related trials for Diabetes Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
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.
Pleun Wouters - van Poppel, MSc principal investigator
Maxima Medical Center
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 2.0 in people with Diabetes Mellitus and 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 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Pleun Wouters-van Poppel, PhD (+31 (0)40 888 6300, pleun.van.poppel@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diabetes self-confidence measured using the Confidence in Diabetes Self-Care Scale (VDZ) (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07812623, which also lists 2 linked publications.
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 10 Sep 2026.