FLASH-UK
Trial question
What is the role of intermittently scanned continuous glucose monitoring in patients with T1DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 156
156 patients (69 female, 87 male)
Inclusion criteria: adult patients with T1DM and glycated hemoglobin levels between 7.5-11.0%
Key exclusion criteria: current use of real-time continuous glucose monitors or intermittently scanned continuous glucose monitoring for > 4 weeks within the previous 12 weeks; pregnancy or planned pregnancy; and complete loss of awareness of hypoglycemia
Interventions
N=78 flash glucose monitoring (intermittently scanned continuous glucose monitoring with free style libre 2 device)
N=78 self-monitoring of blood glucose (monitoring own blood glucose levels with fingerstick testing)
Primary outcome
Glycated hemoglobin level at 24 weeks
7.9
8.3
8.3 %
6.2 %
4.2 %
2.1 %
0.0 %
Flash glucose
monitoring
Self-monitoring of blood
glucose
Significant
decrease ▼
NNT = 249
Significant decrease in glycated hemoglobin level at 24 weeks (7.9% vs. 8.3%; ARD -0.5, 95% CI -0.7 to -0.3)
Secondary outcomes
Significant increase in time spent in target glucose range of 70-180 mg/dL at week 24 (52.1% vs. 45.2%; AD 9%, 95% CI 4.7 to 13.3)
Significant decrease in time spent in hypoglycemia at week 24 (3.5% vs. 6.5%; ARD -3, 95% CI -4.5 to -1.4)
Significant decrease in time spent in hyperglycemia at week 24 (44.5% vs. 48.3%; ARD -6, 95% CI -11 to -0.9)
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with T1DM and glycated hemoglobin levels between 7.5-11.0%, flash glucose monitoring was superior to self-monitoring of blood glucose with respect to glycated hemoglobin level at 24 weeks.
Reference
Lalantha Leelarathna, Mark L Evans, Sankalpa Neupane et al. Intermittently Scanned Continuous Glucose Monitoring for Type 1 Diabetes. N Engl J Med. 2022 Oct 20;387(16):1477-1487.
Open reference URL