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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

RECRUITINGN/ASponsored by Maxima Medical Center
Actively Recruiting
PhaseN/A
SponsorMaxima Medical Center
Started2026-08-05
Est. completion2027-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07812623

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

DiabetesDiabetes MellitusDiabetes Mellitus, Type 2

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