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 <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 HbA1c, mean self-monitoring 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.
Highlights
The present analysis included 70 participants from the intervention arm: 6 participants in this arm had fewer than 3 days of continuous glucose monitoring (CGM) data at baseline, and they were excluded from this analysis
The analysis reported here extends the findings of the SMILE study,[7] showing that baseline mean number of sensor hypoglycemic events (MNSHE) is the strongest predictor of reductions in MNSHE; each additional MNSHE
The finding that the extent of hypoglycemia reduction induced by technological interventions is a function of the baseline prevalence of hypoglycemia is not new: A 2008 meta-analysis of 22 studies in people with type 1 diabetes found that the greatest reductions in hypoglycemia achieved with continuous subcutaneous insulin infusion were seen in individuals with the highest rates of severe hypoglycemia on multiple daily injections.[8]
Summary
Attempts to achieve optimal glycemia often incur an increased risk of severe hypoglycemia.[1,2,3] Risk factors for severe hypoglycemia include duration of diabetes, previous severe hypoglycemic events, and hypoglycemia unawareness, which are present in *20% of people with type 1 diabetes.[4,5] The recent SMILE (Study of MiniMed 640G insulin pump with Smart Guard in prevention of low glucose events in adults with type 1 diabetes) study[6,7] showed that the use of the Medtronic MiniMedÔ 640G insulin pump system with continuous glucose monitoring (CGM) and automated predictive low glucose management (PLGM) reduced hypoglycemic episodes (defined as sensor glucose £55 mg/dL [3.1 mmol/L] lasting ‡20 consecutive minutes) by 73%, and severe hypoglycemic episodes by 83.3%, in adults with type 1 diabetes at high risk of severe hypoglycemia This further analysis of the SMILE study data examined the association between the reduction in hypoglycemic episodes during the study and baseline characteristics in participants in the intervention arm, to identify factors predictive of greater reductions in hypoglycemia, and those individuals most likely to benefit from PLGM suspend before low functionality.
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