Development of a target product profile for new glucose self-monitoring technologies for use in low- and middle-income countries.

Aims: Most glucose self-monitoring devices have been developed with high-income countries in mind. We developed a target product profile (TPP) for new glucose self-monitoring technologies for users in low- and middle-income countries (LMICs).
Methods: A draft TPP including 39 characteristics was developed by an expert group including diabetes specialists, device specialists, and people with diabetes, incorporating findings from qualitative research in LMICs. Each characteristic had minimal and optimal requirements for two use cases, frequent and sporadic use. Characteristics requiring refinement were identified via online survey. Characteristics with agreement level <90% for any requirement were reviewed by the expert group and amended as appropriate.
Results: One characteristic (shelf life) had agreement <75% (both requirements for both use cases). Characteristics with agreement ≥75% and <90% for the frequent use case included infrastructure level, measurement cycle, duration of use before replacement, interchangeability, and calibration (both requirements), and activity log and price per month to end payer (minimal requirement). Intended use (both requirements), accuracy, and price per month to end payer (optimal requirement) had agreement ≥75% and <90% for the sporadic use case.
Conclusions: This TPP will inform developers on requirements for glucose self-monitoring technologies for LMICs, and support decision-makers in evaluating existing devices.
Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: BV and ES declare that they are employed by FIND. SP is an employee of Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT), which carries out clinical studies, e.g., with medical devices for diabetes therapy, on its own initiative and on behalf of various companies. IfDT and/or its employees has/have received speakers’ honoraria or consulting fees in the last 3 years from Abbott, Ascensia, Berlin Chemie, Boydsense, Dexcom, Lilly, Metronom, mySugr, Novo Nordisk, Pharmasens, Roche, Sanofi, and Terumo. All other authors declare that they have no competing interests.
(Copyright: © 2024 Safary et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)