TY - JOUR
T1 - Use of flash glucose-sensing technology (FreeStyle Libre) in youth with type 1 diabetes
T2 - AWeSoMe study group real-life observational experience
AU - Landau, Zohar
AU - Abiri, Shirli
AU - Gruber, Noah
AU - Levy-Shraga, Yael
AU - Brener, Avivit
AU - Lebenthal, Yael
AU - Barash, Galia
AU - Pinhas-Hamiel, Orit
AU - Rachmiel, Mariana
N1 - Publisher Copyright:
© 2018, Springer-Verlag Italia S.r.l., part of Springer Nature.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Aims: Frequent glucose testing is required for optimal management of type 1 diabetes (T1D). Limited data are available regarding real-world experience of the novel technology for monitoring by continuous interstitial fluid glucose (IFG), using flash glucose-sensing technology (FSL-CGM). We aimed to assess the effect of FSL-CGM in a real-life clinical setting on glycemic control parameters, compliance, and adverse events among pediatric and young adult T1D patients. Methods: This observational multi-center study assessed FSL-CGM use (6–12 months) in T1D patients (mean ± SD age 13.4 ± 4.9 years) who purchased the device out-of-pocket. Outcome measures included HbA1c, mean IFG levels, CGM metrics [time in hypoglycemia (< 54 mg/dL; < 3 mmol/L), in target range (70–180 mg/dL; 3.9–10 mmol/L), and in hyperglycemia > 240 mg/dL; > 13.3 mmol/L)], frequency of self-monitoring of blood glucose, acute complications, skin reactions, and reasons for initiation/discontinuation. Results: Among patients with regular use of the FSL-CGM (n = 59), mean HbA1c decreased from 8.86 ± 0.23 to 8.05 ± 0.2% (73.3–64.5 mmol/mol) in 3 months (p = 0.0001) and plateaued thereafter. A clinically significant reduction in HbA1c (defined as a decrease of ≥ 0.5%) was associated with shorter diabetes duration. Of 71 patients who initiated use of the FSL-CGM, 12 (16.9%) discontinued during the study period. No statistically significant changes were found after FSL-CGM use, in mean and standard deviation IFG levels, and in time of glucose levels in target, hypoglycemia, and hyperglycemia ranges. One patient with hypoglycemia unawareness was found dead-in-bed while using FSL-CGM. Conclusions: Real-life observational data in a self-selected young T1D population demonstrated a significant and sustained reduction in HbA1c with FSL-CGM in one-third of the participants. Surveillance of glucose monitoring should be individualized, especially for patients with hypoglycemia unawareness.
AB - Aims: Frequent glucose testing is required for optimal management of type 1 diabetes (T1D). Limited data are available regarding real-world experience of the novel technology for monitoring by continuous interstitial fluid glucose (IFG), using flash glucose-sensing technology (FSL-CGM). We aimed to assess the effect of FSL-CGM in a real-life clinical setting on glycemic control parameters, compliance, and adverse events among pediatric and young adult T1D patients. Methods: This observational multi-center study assessed FSL-CGM use (6–12 months) in T1D patients (mean ± SD age 13.4 ± 4.9 years) who purchased the device out-of-pocket. Outcome measures included HbA1c, mean IFG levels, CGM metrics [time in hypoglycemia (< 54 mg/dL; < 3 mmol/L), in target range (70–180 mg/dL; 3.9–10 mmol/L), and in hyperglycemia > 240 mg/dL; > 13.3 mmol/L)], frequency of self-monitoring of blood glucose, acute complications, skin reactions, and reasons for initiation/discontinuation. Results: Among patients with regular use of the FSL-CGM (n = 59), mean HbA1c decreased from 8.86 ± 0.23 to 8.05 ± 0.2% (73.3–64.5 mmol/mol) in 3 months (p = 0.0001) and plateaued thereafter. A clinically significant reduction in HbA1c (defined as a decrease of ≥ 0.5%) was associated with shorter diabetes duration. Of 71 patients who initiated use of the FSL-CGM, 12 (16.9%) discontinued during the study period. No statistically significant changes were found after FSL-CGM use, in mean and standard deviation IFG levels, and in time of glucose levels in target, hypoglycemia, and hyperglycemia ranges. One patient with hypoglycemia unawareness was found dead-in-bed while using FSL-CGM. Conclusions: Real-life observational data in a self-selected young T1D population demonstrated a significant and sustained reduction in HbA1c with FSL-CGM in one-third of the participants. Surveillance of glucose monitoring should be individualized, especially for patients with hypoglycemia unawareness.
KW - Continuous glucose monitoring
KW - Flash glucose monitoring system
KW - FreeStyle libre
KW - Hypoglycemia unawareness
KW - Type 1 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85052970979&partnerID=8YFLogxK
U2 - 10.1007/s00592-018-1218-8
DO - 10.1007/s00592-018-1218-8
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C2 - 30171412
AN - SCOPUS:85052970979
SN - 0940-5429
VL - 55
SP - 1303
EP - 1310
JO - Acta Diabetologica
JF - Acta Diabetologica
IS - 12
ER -