Ana María Gómez1, Diana Cristina Henao2, Angelica Imitola3, Oscar Mauricio Muñoz4, Martín Alonso Rondón Sepúlveda5, Laura Kattah3, Juan Sebastian Guerrero6, Elly Morros6, Juan Pablo Llano7, Maira García Jaramillo8, Fabián León-Vargas9. 1. Pontificia Universidad Javeriana, Bogotá, Colombia; Endocrinology Unit, Hospital Universitario San Ignacio, Bogotá, Colombia. Electronic address: amgomezm5@gmail.com. 2. Endocrinology Unit, Hospital Universitario San Ignacio, Bogotá, Colombia. 3. Pontificia Universidad Javeriana, Bogotá, Colombia; Endocrinology Unit, Hospital Universitario San Ignacio, Bogotá, Colombia. 4. Pontificia Universidad Javeriana, Bogotá, Colombia; Endocrinology Unit, Hospital Universitario San Ignacio, Bogotá, Colombia; Department of Clinical Epidemiology, Pontificia Universidad Javeriana, Colombia. 5. Department of Clinical Epidemiology, Pontificia Universidad Javeriana, Colombia. 6. Pontificia Universidad Javeriana, Bogotá, Colombia. 7. Associate Professor Fundación Universitaria Sanitas, Colombia. 8. Universidad EAN, Bogotá, Colombia. 9. Universidad Antonio Nariño, Bogotá, Colombia.
Abstract
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.
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.
Keywords:
Continuous glucose monitoring; Diabetes mellitus tipo 1; Hipoglucemia severa; Low glucose suspend; Monitoreo continuo de glucosa; Predictive low-glucose suspend; Sensor-augmented pump therapy; Severe hypoglycemia; Suspensión antes del límite bajo; Suspensión en hipoglucemia; Terapia con bomba de insulina integrada a sistema de monitoreo continuo; Type 1 diabetes mellitus
Authors: Ileana Mardare; Stephen M Campbell; Johanna C Meyer; Israel Abebrese Sefah; Amos Massele; Brian Godman Journal: Front Pharmacol Date: 2022-01-14 Impact factor: 5.810
Authors: Maria Kamusheva; Konstantin Tachkov; Maria Dimitrova; Zornitsa Mitkova; Gema García-Sáez; M Elena Hernando; Wim Goettsch; Guenka Petrova Journal: Front Endocrinol (Lausanne) Date: 2021-03-16 Impact factor: 5.555