Objective: This study was designed to assess diabetes-related distress and its association with clinical outcomes in patients with type 2 diabetes using basal insulin who were treated with pramlintide.
Methods: In a 16-week, double-blind, placebo-controlled study 211 patients using insulin glargine with or without oral antidiabetes agents were randomized to addition of pramlintide or placebo. Clinical outcomes (change in A1C, postprandial glucose, daily basal insulin dose, and weight) and during-trial hypoglycemia were assessed, along with the Diabetes Distress Scale (DDS). The DDS assesses overall diabetes distress and four subdomains: regimen distress (RD), emotional burden (EB), interpersonal distress (ID), and physician-related distress (PD). Hierarchical, stepwise multiple regression was used to assess the association of clinical outcomes and during-trial hypoglycemia with DDS score changes during the study.
Results: Pramlintide use was associated with a significant reduction in total DDS and RD, but only among those above the median of distress at baseline. Across treatment groups, reduction in basal insulin dose was linked to a drop in total DDS, RD, EB, and ID, reduction in postprandial glucose was associated with reduced total DDS and ID, and reduction in A1C was associated with reduced EB and RD. PD was not associated with hypoglycemia or any clinical outcome. Reduction in weight and incidence of hypoglycemia were not associated with any DDS measure.
Conclusions: Pramlintide use reduced diabetes-related distress among those with high levels of distress at baseline, and better clinical outcomes were associated with improvements in several domains of diabetes-related distress. Efforts should be made to enhance these potential benefits of treatment.
Trial registration: ClinicalTrials.gov NCT00240253.