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Aims/Introduction  ‘The Standard Diabetes Manual’ has been developed by clinical researchers from multiple major institutions in Japan, such as the National Center for Global Health and Medicine, as a comprehensive disease management program, including collaboration between primary care physicians ( PCP s) and specialist services. The present study evaluated the efficacy of the manual as a quality improvement strategy in diabetes care by  PCP s.    Materials and Methods  A total of 42  PCP s in eight domestic districts of the Japan Medical Association were allocated to either the intervention group or the control group in a cluster‐randomized design. The  PCP s in both groups were provided with a copy of the  Diabetes Treatment Guide  published by the Japan Diabetes Society, and the  PCP s in the intervention group additionally received a copy of the manual and a 30‐min relevant seminar at the inception of the intervention. The primary end‐point was the adherence to the following performances as quality indicators: evaluation of retinopathy, and urinary albumin excretion measurements and serum creatinine measurements, as recommended by the Japan Medical Association.    Results  A total of 416 patients were enrolled by 36  PCP s. During the 1‐year follow‐up period, the proportion of  PCP s who adhered to recommendation‐concordant measurements of urinary albumin excretion was significantly higher in the intervention group than in the control group (adherence: 17.9% vs 5.3%,  P  = 0.016). The other parameters were not statistically different between the two groups.    Conclusions  Implementation of ‘The Standard Diabetes Manual’ potentially leads to an improved quality of diabetes management by  PCP s.

journal of diabetes investigation

Cluster‐randomized trial to improve the quality of diabetes management: The study for the efficacy assessment of the standard diabetes manual (SEAS‐DM)