Overview
Background
In people with type 1 diabetes and high glycated hemoglobin levels, the benefits of continuous glucose monitoring with intermittent scanning with optional high and low glucose alarms are unknown.
method
In a parallel-group, multicenter, randomized, controlled trial in participants with type 1 diabetes and glycated hemoglobin levels of 7.5% to 11.0%, participants were asked to measure the efficacy of continuous blood glucose monitoring with intermittent scans at their fingertips. was investigated in comparison with monitoring blood glucose levels in test. The primary outcome was glycated hemoglobin level at 24 weeks, analyzed according to the intention-to-treat principle. Key secondary outcomes included sensor data, participant-reported outcome measures, and safety.
result
A total of 156 participants were randomly assigned in a 1:1 ratio to undergo continuous blood glucose monitoring with intermittent scans (intervention group, 78 participants) or self-tested with a fingerstick test. (usual care group, 78 participants). The mean age (±SD) of the participants at baseline she was 44±15 years, and the mean duration of diabetes she was 21±13 years. His 44% of participants were female. Mean baseline glycated hemoglobin levels were 8.7±0.9% in the intervention group and 8.5±0.8% in the usual care group.These levels decreased to 7.9±0.8% and 8.3±0.9%, respectively, at 24 weeks (adjusted mean between-group difference, -0.5 percentage points; 95% confidence interval [CI], -0.7 to -0.3; P<0.001). The number of hours per day that blood glucose levels were within the target range was 9.0 percentage points (95% CI, 4.7 to 13.3) longer or 130 minutes (95% CI, 68 to 13.3) more in the intervention group than in the usual care group. 192) was long. group, and time spent in hypoglycemia (blood glucose, <70 mg per deciliter) [<3.9 mmol per liter]) was 3.0 percentage points (95% CI, 1.4 to 4.5) lower or 43 minutes (95% CI, 20 to 65) shorter in the intervention group. Two of her participants in the usual care group had episodes of severe hypoglycemia and one of her participants in the intervention group had cutaneous reactions to the sensor.
Conclusion
Among participants with type 1 diabetes and high glycated hemoglobin levels, using intermittently scanned continuous glucose monitoring with optional hyper- and A significantly lower glycated hemoglobin level was also obtained. (Funded by Diabetes UK and others; FLASH-UK ClinicalTrials.gov number, NCT03815006.)