User requirements for non-invasive and minimally invasive glucose self-monitoring devices in low-income and middle-income countries: a qualitative study in Kyrgyzstan, Mali, Peru and Tanzania

Aims Development of non-invasive and minimally invasive glucose monitoring devices (NI-MI-GMDs) generally takes place in high-income countries (HICs), with HIC's attributes guiding product characteristics. However, people living with diabetes (PLWD) in low-income and middle-income countries (LMICs) encounter different challenges to those in HICs. This study aimed to define requirements for NI-MI-GMDs in LMICs to inform a target product profile to guide development and selection of suitable devices. Methods This was a multiple-methods, exploratory, qualitative study conducted in Kyrgyzstan, Mali, Peru and Tanzania. Interviews and group discussions/activities were conducted with healthcare workers (HCWs), adults living with type 1 (PLWD1) or type 2 diabetes (PLWD2), adolescents living with diabetes and caregivers. Results Among 383 informants (90 HCW, 100 PLWD1, 92 PLWD2, 24 adolescents, 77 caregivers), a range of differing user requirements were reported, including preferences for area of glucose measurement, device attachment, data display, alert type and temperature sensitivity. Willingness to pay varied across countries; common requirements included ease of use, a range of guiding functions, the possibility to attach to a body part of choice and a cost lower than or equal to current glucose self-monitoring. Conclusions Ease-of-use and affordability were consistently prioritised, with broad functionality required for alarms, measurements and attachment possibilities. Perspectives of PLWD are crucial in developing a target product profile to inform characteristics of NI-MI-GMDs in LMICs. Stakeholders must consider these requirements to guide development and selection of NI-MI-GMDs at country level, so that devices are fit for purpose and encourage frequent glucose monitoring among PLWD in these settings.