To assess the quality of life (QOL) in elderly diabetic patients, 452 elderly outpatients aged over 60 years old who lived in 4 districts near our hospital were visited at home and of them were asked to follow 83 questionnaires concerning QOL by professional interviewers. Using the 37 questions about the impact of diabetes on elderly diabetic patients, we have developed the Elderly Diabetes Impact Scales (EDIS). The EDIS consisted of 6 subscales (burden of symptoms, burden of daily life, burden of diet therapy, burden of drug therapy, satisfaction, worry). Responses to questions were estimated with a 4-point multiple-choice assessment. The impact was rated from 1 (no impact, never worried, or very satisfied) to 4 (very burdened, always worried, or very dissatisfied) for each question and total EDIS scores were calculated by summing up the scores of the 37 questions. The internal consistency of the EDIS and its six subscales were of a satisfactory magnitude (0.66-0.88). There was also a significant correlation between the EDIS and PGC morale scales (r = -0.48, p < 0.001) and between the EDIS subscales and 3 moral components suggesting a convergent validity of the EDIS. The EDIS may be useful in evaluating the quality of life in elderly patients with diabetes mellitus.