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

PLoS One. 2024 Aug 26;19(8):e0309062. doi: 10.1371/journal.pone.0309062. eCollection 2024.

Abstract

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.

MeSH terms

  • Blood Glucose / analysis
  • Blood Glucose Self-Monitoring* / economics
  • Blood Glucose Self-Monitoring* / instrumentation
  • Blood Glucose Self-Monitoring* / methods
  • Developing Countries*
  • Diabetes Mellitus / blood
  • Humans

Substances

  • Blood Glucose

Grants and funding

This work was supported by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) [BV], the Swiss Agency for Development and Cooperation (Direktion für Entwicklung und Zusammenarbeit)[BV] and the Leona M. and Harry B. Helmsley Charitable Trust [ML, ME]. The funders did not play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.