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.. Research Support; Self; JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases. D.M. Dreon: Employee; Self; Calibra Medical. V. Aroda: Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc., AstraZeneca, Calibra Medical, Eisai Inc., Sanofi. Consultant; Self; Sanofi. Research Support; Self; Theracos, Inc.. Employee; Spouse/Partner; Merck & Co., Inc.. Other Relationship; Self; American Diabetes Association. Consultant; Self; ADOCIA. T.S. Bailey: Research Support; Self; Abbott. Consultant; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Ambra BioScience, Ascensia Diabetes Care, Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical. Consultant; Self; Calibra Medical. Research Support; Self; Companion Medical, Dexcom, Inc., Glooko, Inc., GlySens Incorporated, Lexicon Pharmaceuticals, Inc., Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; Medtronic MiniMed, Inc.. Consultant; Self; Medtronic MiniMed, Inc.. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Senseonics. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Versartis, Inc., Xeris Pharmaceuticals, Inc., MannKind Corporation. R.L. Brazg: Research Support; Self; Abbott, Calibra Medical, Dexcom, Inc., Eli Lilly and Company, GlucoMe, Novo Nordisk Inc., Medtronic. Speaker's Bureau; Self; Medtronic. Research Support; Self; Sanofi-Aventis, Senseonics, Gan & Lee Pharmaceuticals, Gelesis. J.P. Frias: Research Support; Self; AbbVie Inc., Allergan, Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company. Consultant; Self; CeQur Corporation. Research Support; Self; Cirius Therapeutics, AstraZeneca, Calibra Medical, Elcelyx Therapeutics, Inc.. Consultant; Self; Elcelyx Therapeutics, Inc.. Research Support; Self; Eli Lilly and Company, Genentech, Inc., Ionis Pharmaceuticals, Inc., ICON plc., Janssen Pharmaceuticals, Inc.. Consultant; Self; Johnson & Johnson Diabetes Institute, LLC.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc.. Consultant; Self; Ligand Pharmaceuticals, Inc.. Research Support; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc., Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Theracos, Inc. 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.C. Klonoff: Consultant; Self; Ascensia Diabetes Care, Lifecare, Intarcia Therapeutics, Inc., Voluntis USA, Novo Nordisk Inc., Onduo, Trividia Health, Inc., American Diabetes Association, The Endocrine Society, American Association of Diabetes Educators. D.F. Kruger: Research Support; Self; Dexcom, Inc.. Speaker's Bureau; Self; Dexcom, Inc.. Stock/Shareholder; Self; Dexcom, Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Intarcia Therapeutics, Inc., Abbott. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Research Support; Self; JAEB Center For Health Research. Consultant; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Research Support; Self; Hygieia, Lexicon Pharmaceuticals, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Valeritas, Inc., Insulet Corporation. Consultant; Self; Insulet Corporation. Research Support; Self; Insulet Corporation. Consultant; Self; Merck & Co., Inc. S. Ramtoola: Other Relationship; Self; Janssen Research & Development. Stock/Shareholder; Self; Novo Nordisk A/S, Johnson & Johnson, Eli Lilly and Company. J. Rosenstock: Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Consultant; Self; Sanofi. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Merck & Co., Inc., Pfizer Inc., Sanofi, Novo Nordisk Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Intarcia Therapeutics, Inc., Genentech, Inc. P. Serusclat: Board Member; Self; Novo Nordisk A/S, Medtronic, Abbott. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Sanofi. R.S. Weinstock: Research Support; Self; Medtronic MiniMed, Inc., Mylan, Kowa Pharmaceuticals America, Inc., Diasome Pharmaceuticals, Inc., Calibra Medical, Dexcom, Inc., Ultradian Diagnostics LLC., JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases. R.G. Naik: Other Relationship; Self; LifeScan, Inc.. D.M. Shearer: None. V. Zraick: Other Relationship; Self; Calibra Medical. B.L. Levy: Employee; Self; LifeScan, Inc..