Efficacy of the mHealth application in patients with type 2 diabetes transitioning from inpatient to outpatient care: A randomized controlled clinical trial.

INTRODUCTION: No studies have assessed the efficacy of telemedicine using a platform for recording and adjusting insulin doses in patients with diabetes mellitus type 2 (DM2) transitioning from inpatient to outpatient care. This study aimed to assess, in a population of patients with DM2, discharged from a tertiary referral hospital, whether treatment based on the use of an mHealth application was associated with better glycemic control at the 3-month follow-up, than standard care. METHODS: This open, randomized, controlled clinical trial included adult DM2 patients who were transitioning from inpatient to outpatient care. The efficacy and safety of patient management with and without mHealth was compared at the 3-month follow-up. The primary outcome was the change in the Glycosylated hemoglobin (HbA1c) levels. The secondary outcomes were the rates of hypoglycemic and hyperglycemic events and treatment satisfaction measured using the Insulin Treatment Satisfaction Questionnaire (ITSQ). RESULTS: In total, 86 patients (41 using mHealth) were included in the clinical trial. HbA1c levels showed a significant decrease in both groups. The mean HbA1c level was significantly lower in the mHealth group. Patients using mHealth showed decreased incidence rate ratios of hypoglycemia 3.0 mmol/L [<54 mg/dl], hypoglycemia ranging from 3.0 to 3.8 mmol/L [54 to 70 mg/dl] and severe hypoglycemia. The level of satisfaction assessed using the ITSQ was higher in the mHealth group. CONCLUSION: Using mHealth in patients with DM2 transitioning from inpatient to outpatient care improves metabolic control and may reduce the hypoglycemia rates.

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