User-and health care provider-reported outcomes for a wearable bolus insulin delivery patch.
Levy BL, Bergenstal RM, Dreon DM, Zraick V, Aroda VR, Bailey TS, Brazg RL, Frias JP, Klonoff DC, Kruger DF, Ramtoola S, Rosenstock J, Serusclat P, Weinstock RS, and Peyrot M. User-and health care provider-reported outcomes for a wearable bolus insulin delivery patch. Diabetologia 2018; 61:S415.
Background and aims: This multi-center randomized, controlled trial compared efficacy, safety, and User- /Health Care Providerreported outcomes for adults with type 2 diabetes (HbA1c: 7.5- 11% [58-97 mmol/mol]) on basal insulin initiating mealtime insulin (aspart) with a wearable bolus insulin delivery patch (Patch, n = 139) vs an insulin pen (Pen, n =139). Patch was applied at least every 3 days and delivered subcutaneous bolus insulin in 2- U increments per manual click. Materials and methods: Study durationwas 48 weeks with cross-over at Week 44; 88% of Patch Users and 86% of Pen Users completedWeek 24 assessments; 77% and 76%, respectively, completed Week 48 assessments. TreatingHealth Care Providers (n = 89) rated their experience with Patch at Week 24. Results: Change in HbA1c from baseline to Week 24 (primary endpoint) was significant (p < 0.0001) in both groups (least squares mean change ± SEM: Patch, -1.7 ± 0.1% [-19 ± 1.0 mmol/mol] vs Pen, -1.6 ± 0.1% [-17 ± 1.0 mmol/mol]). 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 < 0.01). Change in User quality of life (measured by the Diabetes-Specific Quality of Life Survey) at Week 24 favored Patch over Pen for 6 of 7 measures; comparisons for daily functions and diet restrictions were significant (p < 0.05). Comparisons of User experience ratings at Week 24 favored Patch over Pen for all 11 items; 7 of those showed a significant difference (Table). A User preference survey (Week 48) indicated a significant preference for Patch over Pen in those who used Patch for 44 weeks and those who crossed over to Patch for 4 weeks (p < 0.0001); 69% in Patch group wanted to switch from Pen to Patch or had no preference (10%). Health Care Provider questionnaire ratings in favor of Patch at Week 24 ranged from 67% to 85% (p < 0.0001). Additionally, 74% rated training for Patch use as “easy” and 89% reported that it took ≤30 minutes; 91% of Health Care Providers preferred Patch over Pen for initiating mealtime insulin (p < 0.0001). Conclusion: The Patch is a viable alternative to Pen for mealtime insulin; both Users and Health Care Providers preferred patch to pen. (Table Presented)