Flash glucose monitoring is now included in the Portfolio of Services of the Public Health System of Andalusia in Spain. We enrolled 145 paediatric T1D diabetes patients into a prospective, interventional study of the impact of the FreeStyle Libre system on HbA1c levels in this population, as well as additional measures of glycemic health, such as Time in Range (TIR) and Time Below Range (TBR). Subjects were trained in use of the FreeStyle Libre system at the start of the study.
Mean age (± SD) of patients was 11.4 (± 3.1) years and average duration of diabetes was 5.2 (± 3.2) years. Patients were treated either with continuous subcutaneous insulin infusion (CSII; n=26) or with multiple doses of insulin (MDI; n=119). Outcomes measurements were performed at initiation, at 1 month, at 3 months and at 6 months.
Stratification of patients based on metabolic control showed that those with a baseline HbA1c ≥7.5% had a significant reduction in mean HbA1c at 3 months (8.11±0.71% vs 7.7±0.6%; P=0.04). In contrast, those with a baseline HbA1c <7.5% showed a significant increase in HbA1c at 3 months (6.75±0.48% vs 6.98±0.69%; P=0.03). Stratification of patients by treatment type (CSII vs. MDI) shows a significant reduction in HbA1c in those on CSII from baseline at month 3 and at month 6 (P=0.032). Amongst patients with baseline HbA1c ≥7.5% there was a significant reduction from baseline at 3 months with MDI therapy and this was very marked (9.66±0.80% vs 7.70±0.85%; P=0.04).
There was no significant change in TIR or in TBR <70 mg/dL. This may be attributed to the fact that was no masked baseline and any changes would have occurred within two days of the first sensor wear. However, the frequency of Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycaemia was lowest in subjects who scanned their sensors ≥ 10 times per day. Data also indicate a reduction in the rate of Level 3 hypoglycaemia from 4.2 episodes to 0.2 episodes per 100 patients per year after introduction of FreeStyle Libre.
In summary, the FreeStyle Libre system is beneficial in paediatric subjects with T1D to reduce HbA1c. Additional investigation is required to identify which individuals are most likely to benefit from use of the FreeStyle Libre system.
19 - 21 Sep 2019
European Society for Paediatric Endocrinology