Table 6.
Suggested Research Phases for Clinical Trial Development of Continuous Ketone Monitoring.
| Phase 0 | Phase 1 | Phase 2 | Phase 3 | Phase 4 | |
|---|---|---|---|---|---|
| Goal | Proof-of-concept | Feasibility/safety | Efficacy | Efficacy/Effectiveness | Post-Marketing Surveillance |
| Question | Does CKM do what it is expected to do in healthy people? | Does CKM do what it is expected to do in patients at risk for DKA? | Can CKM be used in place of capillary ketone testing for patients at risk for DKA? | What else do we need to know? | |
| Population | Healthy participants on low carbohydrate diets | At-risk for DKA | |||
| Sample size | 12 | 24–36 | 25–100 | 100–300 | – |
| Reference testing | Capillary ketone (8× per day) | Serum β-hydroxybutyrate (clinical research unit- withhold insulin) | – | – | – |
| Comparator group | – | – | Capillary ketone (8× per day) during sick days | – | |