Effect of switching from intermittently scanned to real-time continuous glucose monitoring in adults with type 1 diabetes: 24-month results from the randomised ALERTT1 trial
Authors' conclusion
Glycaemic control and hypoglycaemia worry improved significantly up to 24 months after switching from isCGM without alerts to rtCGM with alerts, supporting the use of rtCGM in the care of adults with type 1 diabetes.
Study context
- Population
- Adults aged ≥18 years with T1D previously using intermittently scanned continuous glucose monitoring (isCGM), six hospitals in Belgiumrandomised 1:1
- Participants
- 254 adults
- Comparison
- Switch from isCGM without alerts to real-time continuous glucose monitoring (rtCGM) with alerts (is-rtCGM) vs continued rtCGM (rt-rtCGM); within-group changes
- is-rtCGMn = 119
- rt-rtCGMn = 123
- Primary endpoint
- Within-group change in TIR (3.9-10.0 mmol/L) vs start of rtCGM
- Follow-up
- Up to 24 months
Methodological detailsdouble-arm, parallel-group, non-masked, multicentre (six hospitals in Belgium), Completed 24 months: 112 (94%) is-rtCGM, 117 (95%) rt-rtCGM
- Double-arm
- Parallel-group
- Non-masked
- Multicentre (six hospitals in Belgium)
- Completed 24 months: 112 (94%) is-rtCGM, 117 (95%) rt-rtCGM
Primary result
As reported in the abstract
TIR change vs start of rtCGM · up to month 24
- is-rtCGM: Time in range (TIR) 51.8% (95% CI 49.1-54.5) at month 6 to 63.5% (60.7-66.3) at month 12, stable to month 24; change 11.7 pp (9.4-14.0), p<0.0001
- rt-rtCGM: TIR 52.5% (95% CI 49.8-55.1) at month 0 to 63.0% (60.3-65.8) at month 12, stable to month 24; change 10.5 pp (8.2-12.8), p<0.0001
- Within-group changes; positive value = lower value at start of rtCGM
Secondary outcomes
HbA1c change vs start of rtCGM · up to month 24
- is-rtCGM: 7.4% (57 mmol/mol; month 6) to 6.9% (52 mmol/mol); change −0.54 pp (95% CI −0.64 to −0.44); −5 mmol/mol (95% CI −6 to −4); p<0.0001
- rt-rtCGM: 7.4% (57 mmol/mol; month 0) to 7.0% (53 mmol/mol); change −0.43 pp (95% CI −0.53 to −0.33); −4 mmol/mol (95% CI −5 to −3); p<0.0001
Hypoglycaemia Fear Survey worry (HFS-worry) score change · up to month 24
- is-rtCGM (month 24 vs month 6), p=0.0008
- −2.67
- rt-rtCGM (month 24 vs month 0), p<0.0001
- −5.17 points
Safety
Time in clinically significant hypoglycaemia (<3.0 mmol/L) · after month 12
- Unchanged in both groups after month 12
Severe hypoglycaemia
- Decreased after switching to rtCGM, per 100 patient-years
- 31.0 to 3.3
Original publication
Effect of switching from intermittently scanned to real-time continuous glucose monitoring in adults with type 1 diabetes: 24-month results from the randomised ALERTT1 trial. Lancet Diabetes Endocrinol. Published February 2023. doi:10. 1016/ s2213-8587(22)00352-7
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