Optimizing Basal-Bolus Therapy in T2D—A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch vs. an Insulin Pen
Authors: BERGENSTAL RICHARD M. , PEYROT MARK , DREON DARLENE M. , ARODA VANITA , BAILEY TIMOTHY S. , BRAZG RONALD L. , FRIAS JUAN P. , JOHNSON MARY L. , KLONOFF DAVID C. , KRUGER DAVIDA F. , RAMTOOLA SHENAZ , ROSENSTOCK JULIO , SERUSCLAT PIERRE , WEINSTOCK RUTH S. , NAIK RAMACHANDRA G. , SHEARER DAVID M. , ZRAICK VIVIEN , LEVY BRIAN L. 
Published: June 2018

This multicenter RCT compared clinical, subject-reported, and safety outcomes in T2D subjects on basal insulin (A1C 7.5-11%) initiating mealtime insulin with a wearable bolus insulin delivery patch (Patch, Calibra Medical) vs. an insulin pen (Pen, NovoLog FlexPen®). The Patch was applied at least every 3 days and delivered subcutaneous bolus insulin in 2-U increments per manual click.

T2D adults (N=278, age: 59.2 y, duration: 15 y), were randomized to Patch (n=139) or Pen (n=139). Baseline glargine dose was divided 1:1, basal:bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly based on fasting and pre-meal glucose targets.

Change in A1C (%) from baseline to Week 24 (primary endpoint) for Patch was noninferior (p&lt;.0001) to Pen (LS mean change ± SE: Patch, −1.69 ± 0.vs. Pen, −1.60 ± 0.08) and this reduction was significant (p&lt;.0001) in both groups. A1C improvement was maintained at 44 weeks (Fig).

There were no significant differences in adverse events, including hypoglycemia (3 severe episodes/group). There were significantly greater improvements in subject-reported outcomes for Patch vs. Pen.

In conclusion, bolus insulin delivered by Patch or Pen along with an algorithm-based weekly insulin dose titration significantly improved A1C levels in subjects with T2D, with improved patient experience and a preference for Patch.

Disclosure

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. M. 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