A 3-year prospective randomized controlled clinical trial of group care in type 1 diabetes

BACKGROUND AND AIMS: We showed that continuing education can be embedded into routine diabetes care by seeing patients in small groups rather than individually. Group care was cost-effective in improving quality of life, knowledge of diabetes, health behaviours and clinical outcomes in people with type 2 diabetes. The aim of this study was to verify if group care can also be applied to type 1 diabetes. METHODS AND RESULTS: Randomized, controlled clinical trial comparing 31 patients managed by group care with 31 managed by traditional one-to-one care. A syllabus was built and later remodulated with the patients in a series of focus-group meetings. The primary end-point was changes in quality of life. Secondary end-points were: knowledge of diabetes, health behaviours, HbA1c and circulating lipids. Differential costs to the Italian National Health System and to the patients were also calculated. After 3 years, quality of life improved among patients on group care, along with knowledge and health behaviours (p<0.001, all). Knowledge added its effects to those of group care by independently influencing behaviours (p=0.004) while quality of life changed independently of either (p<0.001). Among controls, quality of life worsened (p<0.001) whereas knowledge and behaviours remained unchanged. HDL cholesterol increased among patients on group care (p=0.027) and total cholesterol decreased in the controls (p<0.05). HbA1c decreased, though not significantly, in both. Direct costs for group and one-to-one care were Euros 933.19 and Euros 697.10 per patient, respectively, giving a cost-effectiveness ratio of Euros 19.42 spent per point gained in the quality of life scale. CONCLUSIONS: Group care is applicable and also cost-effective in type 1 diabetes. It improves quality of life, knowledge and behaviours. Future programme adjustments should strive to impact more on metabolic control.