User-and health care provider-reported outcomes for a wearable bolus insulin delivery patch.

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Conference Proceeding

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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)



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