BMJ Open Diabetes Research & Care · 2016 · 23 citations · 21 references
MedicineEndocrinologyInternal MedicineClinical PharmacologyDiabetologyPharmacovigilanceDiabetes ControlDiabetes ManagementDiabetes MellitusGlycemic ControlInsulin TherapyOral Antidiabetic AgentsBasal Insulin TherapyGlycemic Control TargetsGlycemic TargetsOral Antidiabetic MedicationsOral Antidiabetic TherapyPostprandial GlycemiaPrandial Insulin AdministrationType 2 Diabetes Mellitus Treatment
INTRODUCTION: In patients with type 2 diabetes mellitus (T2DM) with uncontrolled glycemia despite ongoing upward titration of basal insulin, targeting postprandial hyperglycemia may be required. Nevertheless, the point at which basal insulin is fully optimized and postprandial glucose (PPG) should be targeted with additional treatment remains unclear. We report here on the BeAM value (difference between bedtime and morning blood glucose values) as an indicator of the need to target PPG. METHODS: This study had 3 stages: exploratory, main, and proof-of-concept analyses. For the exploratory and main analyses, data were pooled from phase 3 trials in adults with T2DM adding basal insulin to oral antidiabetic drugs (OADs). The main analysis included only patients who did not reach A1C ≤7.0% (53 mmol/mol) at week 24. The proof-of-concept analysis used pooled data from phase 3 trials in adults with T2DM adding insulin glargine and a single insulin glulisine injection to OADs. RESULTS: In patients undergoing basal insulin titration, BeAM value increased over 24 weeks (27.8-61.7 mg/dL, n=1188; 32.6-71.2 mg/dL, n=553; exploratory and main analyses, respectively). There were significant correlations between week 24 BeAM value and postprandial contribution to hyperglycemia (Pearson's correlation coefficient (r)=0.375, p<0.001; r=0.396, p<0.001; exploratory and main analyses, respectively). When PPG was targeted (proof-of-concept analysis), the BeAM value reduced from 77.0 to 40.4 mg/dL (n=299). CONCLUSIONS: The BeAM value described in this study is a simple, easy-to-calculate value that may identify patients with T2DM using basal insulin that need targeting of postprandial control rather than advancing basal insulin dose.
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