Patients with T2D (N=97, A1c ≥7.5% on basal insulin) used DexCom G4 CGM in a substudy of a large RCT (N=278) to evaluate bolus insulin delivery by patch (Calibra Medical) vs. pen (Novolog Flexpen®) using an SMBG-based titration algorithm.

There was a significant improvement (p<0.0001) in A1c and all CGM metrics at week 24, but no difference between groups (Table). CGM profiles (Figure) demonstrate it is possible to optimize basal-bolus therapy, dramatically increasing time-in-target range (70-180 mg/dL) with minimal significant hypoglycemia (<54 mg/dL) while achieving a flat bedtime to AM glucose profile.

This is one of the first trials to clearly demonstrate how using CGM metrics and CGM profiles in T2D can provide a more clinically relevant comparison of different approaches to optimizing glucose management.

Table: CGM Metrics for Patch (49) and Pen (48), Baseline and Week 24

 Patch Baseline Patch Week 24 Pen Baseline Pen Week 24 
Central Lab A1c, % (± SD) 8.54 ± 0.90 6.82 ± 0.95 8.75 ± 1.03 6.70 ± 0.79 
CGM Average Glucose, mg/dL (± SD) 188.9 ± 40.9 142.4 ± 31.4 200.3 ± 41.4 140.4 ± 28.3 
CGM Glucose >250 mg/dL, % time (± SD) 18.3 ± 18.3 5.6 ± 9.7 23.4 ± 21.8 4.6 ± 8.3 
CGM Glucose >180 mg/dL, % time (± SD) 50.4 ± 26.1 21.1 ± 19.9 56.7 ± 24.8 19.7 ± 17.5 
CGM Glucose 70-180 mg/dL, % time (± SD) 48.4 ± 25.2 74.1 ± 18.7 42.4 ± 23.8 75.2 ± 16.1 
CGM Glucose <70 mg/dL, % time (± SD) 1.2 ± 2.4 4.7 ± 5.2 0.9 ± 3.2 5.1 ± 5.8 
CGM Glucose <54 mg/dL, % time (± SD) 0.2 ± 0.7 1.1 ± 2.0 0.2 ± 1.2 1.2 ± 2.0 
 Patch Baseline Patch Week 24 Pen Baseline Pen Week 24 
Central Lab A1c, % (± SD) 8.54 ± 0.90 6.82 ± 0.95 8.75 ± 1.03 6.70 ± 0.79 
CGM Average Glucose, mg/dL (± SD) 188.9 ± 40.9 142.4 ± 31.4 200.3 ± 41.4 140.4 ± 28.3 
CGM Glucose >250 mg/dL, % time (± SD) 18.3 ± 18.3 5.6 ± 9.7 23.4 ± 21.8 4.6 ± 8.3 
CGM Glucose >180 mg/dL, % time (± SD) 50.4 ± 26.1 21.1 ± 19.9 56.7 ± 24.8 19.7 ± 17.5 
CGM Glucose 70-180 mg/dL, % time (± SD) 48.4 ± 25.2 74.1 ± 18.7 42.4 ± 23.8 75.2 ± 16.1 
CGM Glucose <70 mg/dL, % time (± SD) 1.2 ± 2.4 4.7 ± 5.2 0.9 ± 3.2 5.1 ± 5.8 
CGM Glucose <54 mg/dL, % time (± SD) 0.2 ± 0.7 1.1 ± 2.0 0.2 ± 1.2 1.2 ± 2.0 
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Disclosure

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.. S. Richter: None. D. Mullen: None. 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.

© 2018 by the American Diabetes Association.
2018
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