Summary: This is a published trial protocol (the PARTNER study), not a results paper. It describes the rationale and design of a 6-month randomised, double-masked, placebo-controlled crossover trial in which 60 Australian adults with type 1 diabetes will receive dapagliflozin 10 mg daily plus continuous ketone monitoring versus placebo. The hypothesis is that this combination will improve glycaemic control (CGM time in range) without increasing diabetic ketoacidosis, but no efficacy or safety outcomes have yet been measured or reported.
PICO Summary
| Element | Detail |
|---|---|
| Population | Planned n=60 Australian adults with type 1 diabetes across 5 sites; HbA1c <85.8 mmol/mol (<10%), total daily insulin ≥0.4 IU/kg, ≥100 g carbohydrate/day, and no DKA in the prior 3 months. Randomised double-masked crossover design. |
| Intervention | Dapagliflozin 10 mg daily plus Abbott continuous ketone monitoring and DKA-mitigation education, for 12 weeks per arm (all 60 participants receive this arm during crossover). |
| Comparison | Matching placebo for 12 weeks (within-subject crossover, 2-week washout between periods; all 60 participants receive placebo during the other arm). Continuous ketone monitoring is worn throughout both arms. |
| Outcome | No results reported. Planned primary effectiveness outcome: FreeStyle Libre 2 CGM time in range during the final 2 weeks of each stage. Planned primary safety outcome: number of DKA episodes requiring hospitalisation or emergency department presentation. No effect size, 95% CI, p value, ARR, or NNT exists yet; outcomes are stated as hypotheses only. Trial registration ACTRN12624000448549. |
Expert Commentary
This article is a study protocol, and it must be read as a statement of intent rather than evidence. No participant outcomes have been collected, so any claim that dapagliflozin improved glycaemic control, prevented ketoacidosis, or caused side effects would be unsupported; such conclusions were not, and could not have been, reported here. The design is methodologically sound for the question being asked. A double-masked, placebo-controlled, within-subject crossover limits confounding, and the use of continuous ketone monitoring alongside structured education is a rational strategy for the recognised ketoacidosis hazard of SGLT2 inhibition in type 1 diabetes. The principal limitation is scope and scale: 60 participants over six months in a relatively low-risk, well-controlled Australian population is adequate for a continuous-glucose surrogate endpoint but is underpowered to establish safety against a rare event such as ketoacidosis, so a neutral safety signal here should not be read as proof of safety. The continuous ketone monitor is a single manufacturer’s device, and the question of effectiveness should be interpreted with that dependency in mind. Can I use this with my patients? Not yet. There is nothing here to change practice, and dapagliflozin remains unlicensed for type 1 diabetes in most settings. The results, once reported, should be awaited before any clinical inference is drawn.
References
Ngan J, Kong YW, Goad J, et al. Rationale and design of a randomised phase II multicentre crossover trial investigating a sodium-glucose co-transporter 2 inhibitor, dapagliflozin, combined with a novel continuous ketone monitor in adults with type 1 diabetes to reduce the risk of diabetic ketoacidosis: the PARTNER study. BMJ Open. 2025;15(5):e098457. doi:10.1136/bmjopen-2024-098457
