Towards Standardization of CGM Performance Studies: The QUSS-CGM Questionnaire for Assessing User Satisfaction.

Area of Science:

• Medical Devices
• Diabetes Technology
• Patient-Reported Outcomes

Background:

• User satisfaction and ease of use are critical for continuous glucose monitoring (CGM) system adoption.
• Existing questionnaires for CGM user satisfaction lack standardization, leading to variable item selection across studies.

Purpose of the Study:

• To design, develop, and validate a standardized questionnaire for assessing user satisfaction in CGM performance studies.
• To create the Questionnaire for User Satisfaction Standardized for CGM (QUSS-CGM).

Main Methods:

• Systematic literature search to identify relevant attributes and questionnaire items.
• Content and response process validation by experts and individuals with diabetes.
• Psychometric evaluation including exploratory factor analysis and reliability testing on 126 questionnaires.
• Bidirectional translation to English.

Main Results:

• Identified 205 items, summarized into a 25-item draft questionnaire.
• Achieved acceptable content validity (S-CVI/Ave = 0.90) and face validity (S-FVI/Ave = 0.93).
• Exploratory factor analysis resulted in an 11-item QUSS-CGM with a two-factor structure and high internal consistency (Cronbach's α = 0.84).

Conclusions:

• The QUSS-CGM is a reliable and standardized instrument for measuring user satisfaction in CGM performance evaluation.
• Validated QUSS-CGM facilitates consistent assessment of user experience with CGM devices.