Foundation for Innovative New Diagnostics, Geneva, Switzerland
Division of Tropical and Humanitarian Medicine, University of Geneva, Geneva, Switzerland.
BMJ Open. 2024 Feb 17;14(2):e076685. doi: 10.1136/bmjopen-2023-076685.
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.
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.
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.
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.
非侵入性和微创血糖监测设备(NI-MI-GMD)的开发通常在高收入国家(HIC)进行,HIC 的属性指导产品特征。然而,中低收入国家(LMIC)的糖尿病患者(PLWD)面临的挑战与 HIC 不同。本研究旨在确定 LMIC 对 NI-MI-GMD 的要求,以提供目标产品概况,指导设备的开发和选择。
这是一项在吉尔吉斯斯坦、马里、秘鲁和坦桑尼亚进行的多方法、探索性、定性研究。与卫生保健工作者(HCW)、1 型(PLWD1)或 2 型糖尿病(PLWD2)患者、患有糖尿病的青少年和照顾者进行了访谈和小组讨论/活动。
在 383 名受访者(90 名 HCW、100 名 PLWD1、92 名 PLWD2、24 名青少年、77 名照顾者)中,报告了一系列不同的用户需求,包括对血糖测量区域、设备附件、数据显示、报警类型和温度敏感性的偏好。不同国家的支付意愿有所不同;常见的要求包括易于使用、广泛的引导功能、可附在身体选择部位的可能性以及低于或等于当前血糖自我监测的成本。
易用性和负担能力一直是优先考虑的,报警、测量和附件的广泛功能是必需的。PLWD 的观点对于开发目标产品概况以告知 LMIC 中的 NI-MI-GMD 特征至关重要。利益相关者必须考虑这些要求,以指导国家一级的 NI-MI-GMD 开发和选择,使设备能够满足目的,并鼓励这些环境中的 PLWD 经常进行血糖监测。