Introduction: Type 2 diabetes mellitus (T2DM) exacts tremendous burdens on the patient and patient-focused qualitative research can yield data to deepen our understanding of the individual disease experience.

Methods: Research was conducted to illustrate the T2DM patient experience ranging from its proximal signs/symptoms to its distal impacts (e.g., the disease’s impact on physical, social, or emotional functioning). A targeted literature review, meetings with therapeutic experts, and qualitative concept elicitation interviews with T2DM patients were conducted, and results were thematically analyzed and then harmonized into a conceptual model to organize the sign, symptom, and disease-related impact experiences most relevant to T2DM.

Results: A total of 38 unique sign/symptom and 62 impact concepts of T2DM were identified across the reviewed literature (N=26 publications), expert advice meetings (N=13), and patient interviews (N=20, mean age=60.5±9.5 years, 45% female). The signs/symptoms most frequently reported by patients were tiredness (n=16), dizziness (n=10), and neuropathy-related (n=10), while experts reported excessive thirst (n=12), frequent urination (n=11), and vision problems (n=11) most frequently. For disease impacts, the concepts most frequently reported by both experts and patients were the need to modify diet (n=11 and n=20, respectively), implement an exercise regimen (n=13 and n=17, respectively), and monitor glucose more frequently (n=10 and n=16, respectively). The most bothersome signs/symptoms reported by patients were neuropathy-related (n=8), tiredness (n=5), and vision disorders (n=4).

Conclusions: Patients with T2DM experience many signs, symptoms, and impacts that if improved could give meaningful treatment benefit. Data generated from this research could be used by researchers and healthcare providers to identify treatment outcomes and inform the target concepts of T2DM questionnaires to reliably assess those outcomes.


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.

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