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.