Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial

Abstract

Background: This analysis from the SMILE randomized study was performed to identify predictive factors associated with the greatest reductions in hypoglycemia with the Medtronic MiniMedÔ 640G Suspend before low feature in adults with type 1 diabetes at high risk of severe hypoglycemia. Methods: Clinical and treatment-related factors associated with decreased sensor hypoglycemia (SH) were identified in participants from the intervention arm by univariate and multivariate analyses. Results: The reduction in SH events <54 mg/dL (<3.0 mmol/L) in the intervention group was significantly (P < 0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54 mg/dL. When excluding continuous glucose monitoring (CGM) factors not readily available (MNSHE, duration of SH events, area under the curve, mean amplitude of glycemic excursions), only the baseline mean time spent <54 mg/dL was found to be a significant independent predictor factor (P < 0.0001). Baseline HbA1 c , mean selfmonitoring of blood glucose (SMBG), and coefficient of variation of SMBG were significant, although weak, predictors in the absence of any CGM data. Conclusions: The greatest reductions in SH events achieved with the MiniMed 640G system with the Suspend before low feature were seen in participants with higher baseline MNSHE. Measuring these (usually uncollected) events can be a useful tool to predict hypoglycemia reduction. ClinicalTrials.gov Registration Identifier NCT02733991.

Long-term efficacy of sensor-augmented pump therapy (Minimed 640G system) combined with a telemedicine follow-up in patients with type 1 diabetes: A real life study

“…As reported in a few prospective randomized studies, the use of PLGM in T1D significantly reduced hypoglycemic events, including severe hypoglycemia [7] , [19] , [20] . We found a downward trend in TBR over the 3 years of follow-up in all groups, with a statistically significant decrease in patients who switched to the 640G system at baseline and in those with severe hypoglycemia before PLGM use.…”