Abstract
AIMS: We sought to develop descriptions of health states associated with daytime and nocturnal hypoglycemia in a structured fashion from the patient's perspective under different combinations of severity and frequency of hypoglycemic events. METHODS: An expert meeting followed by two patient focus groups was used to develop comprehensive descriptions of acute consequences of severe and non-severe, daytime and nocturnal hypoglycemia. Patients with diabetes (type 1 = 85, type 2 = 162) from a survey panel then validated these descriptions and assessed how often they worried and took different actions to prevent hypoglycemia. Severity and frequency of hypoglycemia were compared with respect to how often people worried and took actions to prevent an event. The effect of hypoglycemia on 35 different life activities was quantitatively compared for patients who had and had not experienced a severe hypoglycemic event. RESULTS: At least 95% of respondents agreed that the detailed patient-level descriptions of health states accurately reflected their experience of severe and non-severe, daytime and nocturnal hypoglycemia, thereby validating these descriptions. Respondents who had experienced a severe hypoglycemic event were generally more adversely affected in their worries and actions and life events than those who experienced only non-severe events; those who experienced nocturnal events were more affected than those who experienced only daytime events. CONCLUSION: The negative psychosocial consequences and undesirable compensatory behaviors arising from hypoglycemia underscore the importance of preventing severe episodes, particularly severe nocturnal episodes. These validated descriptions for hypoglycemia from the patient's perspective may also help inform future qualitative and quantitative research.