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NCT07812623
A Twelve-Week Pilot Study Evaluating the Usability and Preliminary Effects of SugarVita 2.0 in Adults With Type 2 Diabetes
Conditions: Diabetes Mellitus, Diabetes Mellitus Type 2
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Maxima Medical Center
Location: Maxima Medical Centre Eindhoven North Brabant
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. 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07812623). StuddyBuddy aggregates publicly available trial information.