A 44-week, multinational RCT compared efficacy, safety, and subject preference for bolus insulin initiation using a wearable bolus insulin delivery patch (Patch, Calibra Medical) vs. an insulin pen (Pen, NovoLog FlexPen®) in 278 T2D subjects on basal insulin (0.52 U/kg) (A1C: mean ± SD, 8.7% ± 1.0, BMI: 32.6 kg/m2, duration: 15 y), using insulin titration algorithms incorporated into a patient diary.
At randomization, basal insulin dose was divided 1:1, basal:bolus. Subjects used SMBG patterns weekly to adjust insulin doses. The diary also included algorithms for adjusting bolus insulin at each meal if SMBG was above or below target and if meal size was larger or smaller than usual.
At 44 weeks there was significant (p<.0001) improvement in A1C with both Patch (mean ± SD 7.0% ± 0.1) and Pen (7.0% ± 0.1). In addition, 7-point SMBG profiles improved dramatically from baseline to Week 44, showing improved fasting glucose and near-normal post-meal values using this set of algorithms (Fig). Total insulin doses increased (Patch: 1.33 U/kg; Pen: 1.38 U/kg), with a basal:bolus ratio of 40:60 in both groups. There was a low incidence of adverse events and hypoglycemia with no difference between groups.
In summary, by making weekly insulin adjustments based on simple algorithms embedded in a patient glucose diary, T2D subjects can significantly improve A1C values and 7-point glucose profiles.
M.L. Johnson: Research Support; Self; Calibra Medical, Medtronic, Sanofi, Novo Nordisk Inc., Abbott, POPS! Diabetes Care, National Institute of Diabetes and Digestive and Kidney Diseases, Dexcom, Inc., Hygieia, JDRF. D.M. Dreon: Employee; Self; Calibra Medical. B.L. Levy: Employee; Self; LifeScan, Inc. R.M. Bergenstal: Research Support; Self; Johnson & Johnson Services, Inc.. Consultant; Self; Johnson & Johnson Services, Inc.. Research Support; Self; Abbott. Advisory Panel; Self; Abbott. Research Support; Self; Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Takeda Pharmaceuticals U.S.A., Inc., Dexcom, Inc.. Stock/Shareholder; Self; Merck & Co., Inc.. Research Support; Self; Eli Lilly and Company, Sanofi. Advisory Panel; Self; Sanofi, Roche Pharma. Research Support; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Hygieia. Advisory Panel; Self; Hygieia, Glooko, Inc.. Research Support; Self; JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases.
