Factors associated with clinically significant hypoglycemia in patients with type 1 diabetes using sensor-augmented pump therapy with predictive low-glucose management: A multicentric study on iberoamerica.

BACKGROUND AND AIMS: Despite using sensor-augmented pump therapy (SAPT) with predictive low-glucose management (PLGM), hypoglycemia is still an issue in patients with type 1 Diabetes (T1D). Our aim was to determine factors associated with clinically significant hypoglycemia (<54 mg/dl) in persons with T1D treated with PLGM-SAPT. METHOD: ology: This is a multicentric prospective real-life study performed in Colombia, Chile and Spain. Patients with T1D treated with PLGM-SAPT, using sensor ≥70% of time, were included. Data regarding pump and sensor use patterns and carbohydrate intake from 28 consecutive days were collected. A bivariate and multivariate Poisson regression analysis was carried out, to evaluate the association between the number of events of <54 mg/dl with the clinical variables and patterns of sensor and pump use. RESULTS: 188 subjects were included (41 ± 13.8 years-old, 23 ± 12 years disease duration, A1c 7.2% ± 0.9). The median of events <54 mg/dl was four events/patient/month (IQR 1-10), 77% of these events occurred during day time. Multivariate analysis showed that the number of events of hypoglycemia were higher in patients with previous severe hypoglycemia (IRR1.38; 95% CI 1.19-1.61; p < 0.001), high glycemic variability defined as Coefficient of Variation (CV%) > 36% (IRR 2.09; 95%CI 1.79-2.45; p < 0.001) and hypoglycemia unawareness. A protector effect was identified for adequate sensor calibration (IRR 0.77; 95%CI 0.66-0.90; p:0.001), and the use of bolus wizard >60% (IRR 0.74; 95%CI 0.58-0.95; p:0.017). CONCLUSION: In spite of using advanced SAPT, clinically significant hypoglycemia is still a non-negligible risk. Only the identification and intervention of modifiable factors could help to prevent and reduce hypoglycemia in clinical practice.

Efficacy and safety of sensor-augmented pump therapy (SAPT) with predictive low-glucose management in patients diagnosed with type 1 diabetes mellitus previously treated with SAPT and low glucose suspend / Eficacia y seguridad del tratamiento con bomba de insulina con sensor (SAPT) con gestión predictiva de la hipoglucemia en pacientes con diagnóstico de diabetes mellitus tipo 1 tratados previamente con SAPT y suspensión por hipoglucemia

Background: Sensor-augmented insulin pump therapy (SAPT) with low-glucose suspend (LGS) is an effective and safe alternative for treating patients with type 1 diabetes mellitus (T1DM). New predictive low-glucose management (PLGM) systems decrease the severity and duration of hypoglycemic events. However, evidence of benefits in patients previously treated with SAPT-LGS is limited. Methods: A prospective before-after study was conducted in patients with T1DM treated with SAPT-LGS, who were switched to the Minimed(R) 640G system with SmartGuard(R) to assess the impact on A1c levels, severe hypoglycemia (SH), hypoglycemia unawareness (HU), and area under the curve (AUC) <70mg/dL after three months of follow-up. Results: Fifty-five patients with T1DM with a mean age of 37.9 (IQR 6, 79) years and a mean baseline A1c level of 7.52±1.11% were enrolled. After three months under PLGM, A1c levels significantly decreased to 7.18±0.91% (p=0.004). SH rate decreased from 2.47 (CI 0.44, 4.90) to 0.87 (CI 0.22, 1.52) events/patient-year (Incidence rate ratio 0.353, 95% CI 0.178, 0.637), AUC <70mg/dL decreased from 0.59±0.76 to 0.35±0.65mg/dL x minute (p=0.030). HU determined by Clarke questionnaire resolved in 23 out of 30 patients (p=0.002). Conclusions: This study suggests that SAPT with PLGM decreases the frequency of SH, HU, exposure to glucose levels below 70mg/dL, and A1c levels. Based on these results, this therapy should be considered in T1DM patients previously treated with SAPT-LGS with persistent SH and HU. Further clinical trials comparing the efficacy and safety of these features are required

Introducción: La terapia con bomba de insulina integrada a sistema de monitoreo continuo con suspensión en hipoglucemia (SAPT-LGS) es una alternativa efectiva y segura para el tratamiento en pacientes con diabetes tipo 1 (DM1). La función de suspensión antes del límite bajo (PLGM) reduce la gravedad y la duración de los eventos hipoglucémicos. Sin embargo, la evidencia del beneficio en pacientes tratados previamente con SAPT-LGS es limitada. Métodos: Se realizó un estudio longitudinal antes y después con pacientes DM1 tratados con SAPT-LGS que se cambiaron al sistema Minimed(R) 640G con SmartGuard(R), con el fin de evaluar el impacto en los niveles de A1c, hipoglucemia severa (HS), hipoglucemia asintomática (HA) y área bajo la curva (AUC) <70mg/dl después de tres meses de seguimiento. Resultados: Se incluyeron 55 pacientes con DM1, de 37.9 (IQR 6, 79) años, A1c basal de 7.52±1.11%. A los 3 meses bajo PLGM, la A1c se redujo significativamente a 7.18%±0.91% (p=0.004). La tasa de HS se redujo de 2.47 (CI 0.44,4.90) a 0.87 (CI 0.22,1.52) eventos/año del paciente (índice de incidencia 0.353 IC 95%, 0.178, 0.637), el AUC <70mg/dl se redujo de 0,59±0,76 a 0,35±0,65mg/dl x minuto (p = 0,030). HA determinado por el cuestionario Clarke resolvió en 23 de 30 pacientes (p=0,002). Conclusiones: Este estudio sugiere que PLGM reduce la frecuencia de HS, HA, la exposición a niveles de glucosa por debajo de 70mg/dl y A1c. Con base a estos resultados, esta terapia debería considerarse en pacientes con DM1 tratados previamente con SAPT-LGS que persisten con HS e HA. Se requieren ensayos clínicos adicionales que comparen la eficacia y la seguridad de estas características

Efficacy and safety of sensor-augmented pump therapy (SAPT) with predictive low-glucose management in patients diagnosed with type 1 diabetes mellitus previously treated with SAPT and low glucose suspend.

BACKGROUND: Sensor-augmented insulin pump therapy (SAPT) with low-glucose suspend (LGS) is an effective and safe alternative for treating patients with type 1 diabetes mellitus (T1DM). New predictive low-glucose management (PLGM) systems decrease the severity and duration of hypoglycemic events. However, evidence of benefits in patients previously treated with SAPT-LGS is limited. METHODS: A prospective before-after study was conducted in patients with T1DM treated with SAPT-LGS, who were switched to the Minimed® 640G system with SmartGuard® to assess the impact on A1c levels, severe hypoglycemia (SH), hypoglycemia unawareness (HU), and area under the curve (AUC) <70mg/dL after three months of follow-up. RESULTS: Fifty-five patients with T1DM with a mean age of 37.9 (IQR 6, 79) years and a mean baseline A1c level of 7.52±1.11% were enrolled. After three months under PLGM, A1c levels significantly decreased to 7.18±0.91% (p=0.004). SH rate decreased from 2.47 (CI 0.44, 4.90) to 0.87 (CI 0.22, 1.52) events/patient-year (Incidence rate ratio 0.353, 95% CI 0.178, 0.637), AUC <70mg/dL decreased from 0.59±0.76 to 0.35±0.65mg/dL x minute (p=0.030). HU determined by Clarke questionnaire resolved in 23 out of 30 patients (p=0.002). CONCLUSIONS: This study suggests that SAPT with PLGM decreases the frequency of SH, HU, exposure to glucose levels below 70mg/dL, and A1c levels. Based on these results, this therapy should be considered in T1DM patients previously treated with SAPT-LGS with persistent SH and HU. Further clinical trials comparing the efficacy and safety of these features are required.