User- and Health Care Provider–Reported Outcomes for a Wearable Bolus Insulin Delivery Patch
Authors: PEYROT MARK , BERGENSTAL RICHARD M. , 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 efficacy, safety, and User-/HCP-reported outcomes for adults with T2D (Users, A1C: 7.5-11%) on basal insulin initiating mealtime insulin with a wearable bolus insulin delivery patch (Patch, Calibra Medical, n=139) vs. an insulin pen (Pen, NovoLog FlexPen®, n=139). The Patch was applied at least every 3 days and delivered subcutaneous bolus insulin in 2-U increments per manual click.
Study duration was 48 weeks with cross-over at Week 44; 88% (Patch) and 86% (Pen) of Users completed Week 24 assessments; 77% and 76% completed Week 48 assessments. Treating HCPs (N=89) rated their experience with Patch at Week 24.
Change in A1C (%) from baseline to Week 24 (primary endpoint) showed noninferiority of Patch vs. Pen (p&lt;.0001). Change in User satisfaction (measured by the Insulin Delivery System Rating Questionnaire) at Week 24 favored Patch over Pen for all measures; comparisons for convenience and overall satisfaction were significant (p&lt;.01). Change in User quality of life (measured by the Diabetes-Specific Quality of Life Questionnaire) at Week 24 favored Patch over Pen for 6/7 measures; comparisons for daily functions and diet restrictions were significant (p&lt;.05). Comparisons of User experience ratings at Week 24 favored Patch over Pen for all 11 items; 7 of those showed a significant difference (p&lt;.01). At Week 48, User preferences for Patch over Pen among those who had used Patch for 44 weeks ranged from 72% to 82%; 69% wanted to change from Pen to Patch. Results were similar but less pronounced for those who had used Patch for 4 weeks.
HCP questionnaire ratings for clinical appropriateness of Patch at Week 24 ranged from 67% to 85% in favor. Additionally, 74% rated training for Patch use as “easy” and 89% reported that it took ≤30 minutes; 91% of HCPs preferred Patch over Pen for initiating mealtime insulin.
These results suggest that Patch is a viable alternative to Pen for mealtime insulin; both Users and HCPs preferred Patch to Pen.

Disclosure
M. Peyrot: Consultant; Self; Calibra Medical, Eli Lilly and Company, Novo Nordisk Inc.. Research Support; Spouse/Partner; Eli Lilly and Company, Novo Nordisk 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.. 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