FDA qualifies questionnaires for developing insulin-dosing systems

June 26, 2020

The U.S. Food and Drug Administration (FDA) has qualified the INsulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) questionnaires through the Medical Device Development Tools (MDDT) program, the agency said in a news release.

As an MDDT-qualified tool, the INSPIRE questionnaires can be used to qualitatively assess the impact of Automated Insulin Dosing (AID) systems on the psychosocial functioning and quality of life in youth with Type 1 diabetes (ages 8 to17) as well as their parents and caregivers, and in adults with Type 1 diabetes as well as their partners.

AID systems are intended for the management of Type 1 diabetes in children and adults. An AID system includes an insulin pump, a continuous glucose monitoring (CGM) system, and an algorithm. The algorithm uses interstitial glucose values captured by the CGM system and insulin pump dosing history to automatically direct the pump to adjust insulin dosing.

AID systems are unique because their technology automates some aspects of disease management and reduces some manual actions performed by the patient. However, use of an AID system requires a certain amount of trust that the system will help patients manage their Type 1 diabetes, the FDA said.

The INSPIRE questionnaires address factors that are unique to AID systems, such as trusting an automated system and other potential psychological barriers associated with use of the advanced technology. The questionnaires are intended to help assess patient/user perspectives on these factors. Patient perspective information may be useful in the evaluation of the benefits and risks of AID systems.  Sponsors should engage with the FDA to determine the applicability of the INSPIRE questionnaires to their clinical studies.

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