Aklilu Habteab1, Javier Castañeda2, Harold W de Valk3, Pratik Choudhary4, Emanuele Bosi5, Sandrine Lablanche6, Simona de Portu7, Julien Da Silva8, Linda Vorrink9, John Shin10, Ohad Cohen11. 1. Medtronic Bakken Research Center, Maastricht, Netherlands; aklilu.habteab@medtronic.com. 2. Medtronic Bakken Research Center, Maastricht, Netherlands; javier.castaneda@medtronic.com. 3. University Medical Centre Utrecht, Department of Internal Medicine1, F02.126, Heidelberglaan 100, Utrecht, Utrecht, Netherlands, 3584 CX; h.w.devalk@umcutrecht.nl. 4. King's College London, Diabetes, King's College Hospital, Denmark Hill, London, London, United Kingdom of Great Britain and Northern Ireland, SE5 9NU; pratik.choudhary@kcl.ac.uk. 5. IRCC San Raffaele Hospital and San Raffaele Vita Salute University , Diabetes Research Institute , Milano, Italy; bosi.emanuele@hsr.it. 6. Grenoble University Hospital, Clinique d'Endocrinologie Diabétologie Nutrition , Grenoble, France; SLablanche@chu-grenoble.fr. 7. Medtronic International Trading S?rl, Rte du Molliau 31, Tolochenaz, Switzerland, 1131; simona.de.portu@medtronic.com. 8. Medtronic International Trading Sàrl, Diabetes, route du Molliau 31, Tolochenaz, Switzerland, 1131; julien.da.silva@medtronic.com. 9. Medtronic International Trading, Tolochenaz, Switzerland; linda.vorrink@medtronic.com. 10. Medtronic Diabetes, Clinical Research, Northridge, California, United States; john.shin@medtronic.com. 11. Medtronic International Trading Sàrl, Toluchenaz, Tolochenaz, Switzerland, 46733; ohad.cohen@medtronic.com.
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 MiniMed™ 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 <54mg/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) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001). Baseline HbA1c, mean self-monitoring of blood glucose (SMBG) and coefficient of variation (CV) of SMBG were significant, albeit 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.
RCT Entities:
BACKGROUND: This analysis from the SMILE randomized study was performed to identify predictive factors associated with the greatest reductions in hypoglycemia with the Medtronic MiniMed™ 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 <54mg/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) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001). Baseline HbA1c, mean self-monitoring of blood glucose (SMBG) and coefficient of variation (CV) of SMBG were significant, albeit 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.