Introduction: The burdens associated with type 2 diabetes mellitus (T2DM) treatments, particularly injectable treatments, are liabilities to adherence and desired health outcomes. Patient-focused research was conducted to identify critical aspects of treatment burden related to adequate disease control and adherence to treatment.
Methods: A targeted review of the literature, advice meetings with therapeutic experts, and open-ended qualitative concept elicitation interviews with T2DM patients were conducted. Results from this research were thematically analyzed to identify concepts pertinent to T2DM treatment burden, then harmonized and organized into broader categorical domains.
Results: The literature review (N=26 publications), meetings with global experts (N=13), and patient interviews (N=20; mean age=60.5±9.5 years, 45% female) yielded a total of 45 unique concepts associated with T2DM treatment burden, with the most frequently reported by experts being aversion to needles (n=9), polypharmacy (n=8), and cost of medication (n=8); and by patients, treatment regimen (i.e., process of administering treatment; n=16), storage (i.e., refrigeration of medication; n=16), and planning/preparation of treatment administration (n=15). These 45 concepts were organized into eight broader domains: issues with mode of treatment administration/regimen, side effects and efficacy of treatment, impact on activities of daily living, and emotional, financial, social, and work impacts.
Conclusions: Evidence elicited from this research highlights aspects of T2DM treatment burden and substantiates the significant obligation of disease management for patients. The treatment burdens identified here can inform new (1) treatment technologies and regimens to lessen this burden and, ultimately, encourage adherence, glycemic control, and improvement in other health outcomes for patients with T2DM and (2) outcome assessment strategies to evaluate the burden of existing and novel T2DM treatments.
K. Yu-Isenberg: Employee; Self; Intarcia Therapeutics, Inc. G.D. Gray: Employee; Self; Servier Global Medical Affairs. C. Foley: Consultant; Self; Intarcia Therapeutics, Inc., Servier. J.T. Stokes: None. A. Shields: Consultant; Self; Intarcia Therapeutics, Inc. G. Dickie: Consultant; Self; Intarcia Therapeutics, Inc. R. Lamoureux: Research Support; Self; Intarcia Therapeutics, Inc.. C.V. Jackson: None. B. Padilla: None. W. Polonsky: Consultant; Self; Abbott, AstraZeneca, Dexcom, Inc., Sanofi, Novo Nordisk Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Servier, Ascensia Diabetes Care, Merck & Co., Inc., MannKind Corporation, Glooko, Inc., Roche Diabetes Care Health and Digital Solutions.