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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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Eligibility

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

Study details
    Diabetes Mellitus
    Diabetes Mellitus Type 2

NCT07812623

Maxima Medical Center

12 September 2026

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