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A Twelve-Week Pilot Study Evaluating the Usability and Preliminary Effects of SugarVita 2.0 in Adults With Type 2 Diabetes

NCT07812623

RecruitingNA

Sponsor: Maxima Medical Center

Conditions: Diabetes Mellitus, Diabetes Mellitus Type 2

Interventions: SugarVita 2.0

Countries: Netherlands

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Eindhoven, North Brabant, Netherlands