Continuous glucose monitoring versus self-monitoring of blood glucose in individuals with type 2 diabetes: a randomised, multicentre, open-label, superiority trial
Primary result · HbA1cResult — go to the resultAdjusted difference −0.6 % 95% CI −0.8 to −0.3Authors' conclusion
In adults with type 2 diabetes on basal insulin plus modern therapies, real-time CGM improved glycaemic control versus SMBG during self-management and under clinician-supported management.
Study context
- Population
- Adults with T2D on basal insulin plus SGLT2 inhibitors, GLP-1 RA or dual GIP/GLP-1 RA, HbA1c 7.5–11.0%; 24 primary and secondary care centres, UK; mean age 60.7 years, 67% malerandomised 2:1
- Participants
- 303 adults
- Comparison
- Real-time continuous glucose monitoring (CGM) vs continued self-monitoring of blood glucose (SMBG)
- CGMn = 198
- SMBGn = 105reference
- Primary endpoint
- Between-group difference in HbA1c (treatment policy estimand)
- Follow-up
- 16 weeks
Methodological detailsopen-label, parallel-design, multicentre, superiority, 2:1 permuted block randomisation by site, Phase 1 (weeks 1-16): self-management with basal insulin self-titration; phase 2 (weeks 17-32): clinician-supported, additional therapies per national guidance
- Open-label
- Parallel-design
- Multicentre
- Superiority
- 2:1 permuted block randomisation by site
- Phase 1 (weeks 1-16): self-management with basal insulin self-titration; phase 2 (weeks 17-32): clinician-supported, additional therapies per national guidance
Primary result
HbA1c · week 16
Adjusted difference
−0.6 %
95% CI −0.8 to −0.3
P < 0.0001
By group
CGMvs SMBG
adjusted difference −0.6 % (95% CI −0.8 to −0.3); P < 0.0001
As reported in the abstract
Secondary outcomes
%
| Outcome | CGM | SMBG | Adjusted difference (%) (95% CI) | P value | |
|---|---|---|---|---|---|
| HbA1c (key secondary outcome) · week 32Treatment policy estimand | 7.8 (SD 0.9) | 8.3 (SD 1.2) | −0.5 (−0.7 to −0.2) | P < 0.0001 | |
| −1−0.500.5Difference, % (linear scale) |
Baseline HbA1c
Safety
| Outcome | SMBG |
|---|---|
| Adverse events and severe hypoglycaemiaSafety analysis included all randomly assigned participants | |
| Severe hypoglycaemia instances | 2 |
Adverse events and severe hypoglycaemia
- Similar incidence of non-device-related adverse events in both groups
Original publication
Continuous glucose monitoring versus self-monitoring of blood glucose in individuals with type 2 diabetes: a randomised, multicentre, open-label, superiority trial. Lancet Diabetes Endocrinol. Published 23 April 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →