Bernhard Kulzer1, Wilfried Daenschel2, Ingrid Daenschel3, Wendelin Schramm4, Diethelm Messinger5, Joerg Weissmann6, Iris Vesper7, Christopher G Parkin8, Lutz Heinemann9. 1. Forschungsinstitut Diabetes Akademie Bad Mergentheim, Theodor-Klotzbücher-Straße 12, D-97980 Bad Mergentheim, Germany. Electronic address: kulzer@fidam.de. 2. Medizinisches Versorgungszentrum am Küchwald GmbH, Bürgerstr. 2, D-9113 Chemnitz, Germany. Electronic address: daenschel@herzcentrum-chemnitz.de. 3. Medizinisches Versorgungszentrum am Küchwald GmbH, Bürgerstr. 2, D-9113 Chemnitz, Germany; Hausarztpraxis, Karl-Marx-Str. 15-17, D-09328 Lunzenau, Germany. Electronic address: i.daenschel@t-online.de. 4. GECKO Institute for Medicine, Informatics and Economics, Heilbronn University, Max-Planck Str. 39, D-74081 Heilbronn, Germany. Electronic address: wendelin.schramm@hs-heilbronn.de. 5. Biometrics Department, Prometris GmbH, Soldnerstrasse 1, D-68219 Mannheim, Germany. Electronic address: diethelm.messinger@prometris.com. 6. Roche Diabetes Care GmbH, Sandhofer Straße 116, D-68305 Mannheim, Germany. Electronic address: joerg.weissmann@roche.com. 7. Roche Diabetes Care GmbH, Sandhofer Straße 116, D-68305 Mannheim, Germany. Electronic address: iris.vesper@roche.com. 8. CGParkin Communications, Inc., 2352 Martinique Ave, Henderson, NV, USA. Electronic address: chris@cgparkin.org. 9. Science & Co, Geulenstr. 50, D-41462 Neuss, Germany. Electronic address: Lutz.Heinemann@profil.com.
Abstract
AIMS: Globally, many patients with insulin-treated type-2 diabetes are suboptimally controlled. The PDM-ProValue study program evaluated whether integrated personalized diabetes management (iPDM) has the potential to improve clinical outcomes. METHODS:101 practices with 907 patients participated in the 12-month, prospective, controlled, cluster-randomized study program. HbA1c levels, therapy changes, frequency of hypoglycemic episodes, patient reported outcomes, and physician satisfaction were assessed. RESULTS: iPDM led to a greater reduction in HbA1c after 12 months vs. usual care (-0.5%, p < 0.0001 vs. -0.3%, p < 0.0001), (Diff. 0.2%, p = 0.0324). Most of the HbA1c reduction occurred after 3 months and remained stable thereafter. The percentage of patients with therapy adjustments was higher in the iPDM group at all visits (p < 0.01 at week 3, month 3, month 6). Patient adherence at month 12 was higher in the iPDM group compared to baseline (Odds ratio = 2.39; p = 0.0003); also, patient treatment satisfaction (DTSQc: 12.2 vs. 10.4, δ = 1.78, p = 0.004; DTSQs: 31.0 vs. 30.0, δ = 0.924, p = 0.02), and physician satisfaction was higher in the intervention group. CONCLUSIONS: iPDM improved the use of diagnostic data leading to better glycemic control, more timely treatment adjustments (indicating reduced clinical inertia), and increased patient adherence and treatment satisfaction among patients and physicians.
RCT Entities:
AIMS: Globally, many patients with insulin-treated type-2 diabetes are suboptimally controlled. The PDM-ProValue study program evaluated whether integrated personalized diabetes management (iPDM) has the potential to improve clinical outcomes. METHODS: 101 practices with 907 patients participated in the 12-month, prospective, controlled, cluster-randomized study program. HbA1c levels, therapy changes, frequency of hypoglycemic episodes, patient reported outcomes, and physician satisfaction were assessed. RESULTS:iPDM led to a greater reduction in HbA1c after 12 months vs. usual care (-0.5%, p < 0.0001 vs. -0.3%, p < 0.0001), (Diff. 0.2%, p = 0.0324). Most of the HbA1c reduction occurred after 3 months and remained stable thereafter. The percentage of patients with therapy adjustments was higher in the iPDM group at all visits (p < 0.01 at week 3, month 3, month 6). Patient adherence at month 12 was higher in the iPDM group compared to baseline (Odds ratio = 2.39; p = 0.0003); also, patient treatment satisfaction (DTSQc: 12.2 vs. 10.4, δ = 1.78, p = 0.004; DTSQs: 31.0 vs. 30.0, δ = 0.924, p = 0.02), and physician satisfaction was higher in the intervention group. CONCLUSIONS:iPDM improved the use of diagnostic data leading to better glycemic control, more timely treatment adjustments (indicating reduced clinical inertia), and increased patient adherence and treatment satisfaction among patients and physicians.
Authors: Amelia D Dahlén; Giovanna Dashi; Ivan Maslov; Misty M Attwood; Jörgen Jonsson; Vladimir Trukhan; Helgi B Schiöth Journal: Front Pharmacol Date: 2022-01-19 Impact factor: 5.810