975-P: Simplifying Therapy to Assure Glycemic Control and Engagement (STAGE) for Patients with Clinic Refractory Diabetes

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Patients with type 2 diabetes (T2D) who maintain poor glycemic control despite use of complex insulin regimens may not benefit from this costly and burdensome treatment approach. In a 16-week feasibility pilot, we proactively simplified the insulin regimens of patients with clinic refractory T2D, or maintenance of an HbA1c ≥8.5% for ≥1 year despite engagement with Primary or Endocrinology care. We recruited 12 patients with clinic-refractory T2D on 3-4 daily insulin injections. Using an algorithm created for this study, insulin regimens were simplified to 2 daily injections of pre-mixed 70/30 insulin (NPH/regular vial and syringe or Aspart 70/30 Flexpen) or U-500 regular insulin pens. Simplification was followed by weekly telephone calls for 4 weeks to ensure safety and continued insulin adjustments. The next and final scheduled follow-up was at 16 weeks. Primary feasibility and acceptability outcomes were treatment acceptability by the Treatment Acceptability and Preferences (TAP) measure, adherence by the Voils Medication Nonadherence measure and T2D distress by the Diabetes Distress Scale. HbA1c was examined as a secondary outcome at baseline and 16 weeks. Mean patient age was 68.8 (SD 8.9) , 2/12 were female, and 7/12 were African American. At baseline, mean HbA1c was 9.5%, 6/12 reported nonadherence to insulin and 5/12 reported high regimen-related T2D distress. At 16 weeks, retention rate was 100% and 2/12 patients had reverted back to a 3-4 shot regimen due to development of a diabetic foot infection (as a precaution) and gastrointestinal side effects. Mean TAP score was 3.33 (range 0-4) ; 1 less patient reported nonadherence to insulin and 4 less patients reported regimen-related distress at study conclusion. Mean HbA1c improved by 0.66% during the study period. This pilot study demonstrates feasibility and acceptability of insulin simplification for patients with clinic refractory T2D on complex insulin regimens. Disclosure A.Alexopoulos: None. D.Soliman: None. A.Lewinski: Other Relationship; Otsuka America Pharmaceutical, Inc., PhRMA Foundation. E.Strawbridge: None. K.Steinhauser: None. D.Edelman: None. M.J.Crowley: None. Funding Durham VA ADAPT (internal pilot funding)