Aim: The PDM-ProValue study program showed the benefit of iPDM for people with type 2 diabetes mellitus (T2D) on insulin therapy. Here, we analyze which treatment process conditions may be key for this success.
Methods: The study program was conducted over 12 months in a prospective, controlled, cluster-randomized setting. 101 medical practices were randomized to the iPDM arm (n=53) or the control (CNL) arm (n=48). In addition to medical and patient related outcomes, parameters of process quality and data sources for therapy decisions were monitored e.g., by means of Likert-scaled requests.
Results: After 12 months, HbA1c reduction vs. baseline was higher for patients in iPDM (0.5%, p<0.0001) compared to those in CNL (0.3%, p<0.0001; between-group difference=0.2%, p<0.05). The degree of using both patient reports and SMBG data to assess glycemic status increased: after 12 months, 94% of physicians in the iPDM group stated to use a combination of data sources vs. 75% in CNL (Baseline: 56% iPDM, 59% CNL). Similarly, doctors’ appreciation of the combined information of SMBG and HbA1c (iPDM group only) increased in the course of the study. (Baseline: 43%, 12 months: 61%). After 12 months, 82% of physicians rated the usefulness of all information sources high or very high in the iPDM group compared to 49% in CNL (baseline: 28% vs. 28%). Physicians rated the iPDM process as more structured and better adaptable to the individual situation of the patient compared to before iPDM implementation.
Discussion: A more holistic and beneficial use of data sources by implementing iPDM may be key for the improvements observed in this difficult to treat patient group. A more structured treatment process applied by the physicians and better personalization of therapy seem to enhance physician-patient interaction. Physicians’ positive perception of iPDM may facilitate more focused treatment decisions, thereby overcoming clinical inertia.
L. Heinemann: Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Consultant; Self; Roche Diabetes Care Health and Digital Solutions. D. Messinger: Other Relationship; Self; Roche Diagnostics Corporation, Roche Diagnostics Corporation, Roche Pharma, AbbVie Inc., Merck KGaA. W. Schramm: Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. I. Vesper: None. J. Weissmann: Employee; Self; Roche Diabetes Care Deutschland GmbH. B. Kulzer: Research Support; Self; Berlin-Chemie AG. Speaker's Bureau; Self; Berlin-Chemie AG, Novo Nordisk Inc.. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Abbott. Speaker's Bureau; Self; Abbott, Eli Lilly and Company. Advisory Panel; Self; Novo Nordisk Inc., Medtronic, Ascensia Diabetes Care. Speaker's Bureau; Self; Ascensia Diabetes Care.