A Twelve-Week Pilot Study Evaluating the Usability and Preliminary Effects of SugarVita 2.0 in Adults With Type 2 Diabetes
Recruiting · NCT07812623 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
SugarVita 2.0
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Maxima Medical Centre - Eindhoven, North Brabant, Netherlands