Adolescents With Type 1 Diabetes Using Dapagliflozin as an Adjunct-to-Insulin: Perspectives on Experiences of Clinical Trial Participation

Abstract

Objectives: The Adolescent Type 1 diabetes Treatment with SGLT2i for hyperglycEMia & hyPerfilTration (ATTEMPT) study evaluated the impact of sodium-glucose cotransporter-2 inhibitors (SGLT2i) as an adjunct-to-insulin therapy. Adolescent experiences were explored to gain their informed perspective on adjunct-to-insulin medications as a potential therapeutic intervention in pediatric diabetes and clinical trial protocol.

Methods: Within an embedded experimental mixed method design, a qualitative description approach was used with content and thematic analysis to explore emergent findings.

Results: A total of 24 adolescents (n = 13 males), ages 12 to 17 years, participated in semi-structured interviews. Insights were gained from their shared experience, comprising 3 themes describing how: (1) decision-making about trial participation was multifaceted, (2) adhering to an SGLT2i adjunctive medication was non-burdensome, and (3) participating in the trial had unexpected informative benefits, including improved self-management skills and ketone measurement awareness.

Conclusions: Adolescents in the ATTEMPT study did not express a higher burden of daily diabetes management with adjunct-to-insulin therapy. Findings support the value of a strong research team to ensure communication with adolescents with attention to ethical considerations around recruitment, consent, and participation. Adolescent perspectives in efficacy studies of new treatments in type 1 diabetes can optimize trial designs, research validity, and inform outcome findings.

Keywords: Adjunct to insulin therapy; Adolescents; Qualitative; Type 1 Diabetes.