Factors associated with hypoglycemia unawareness and severe hypoglycemia in type 1 diabetes mellitus patients.

AIMS/INTRODUCTION: Several factors are associated with hypoglycemia unawareness and severe hypoglycemia, but few large studies have analyzed Japanese patients with type 1 diabetes. The aim of this study was to analyze the risk factors for hypoglycemia unawareness and severe hypoglycemia in Japanese type 1 diabetes patients. MATERIALS AND METHODS: A self-administered questionnaire investigated events, complications and treatments associated with hypoglycemia in patients with type 1 diabetes. Multiple logistic regression analysis of factors associated with hypoglycemia unawareness and severe hypoglycemia requiring medical treatment was carried out. The coefficient of variation (CV) of blood glucose levels was determined using blood samples collected at six outpatient visits. RESULTS: Of the 1,619 participants, 44.2% and 10.4% experienced hypoglycemia unawareness and severe hypoglycemia, respectively. Mean HbA1c levels in patients with hypoglycemia unawareness were lower than those in patients without hypoglycemia unawareness. The type 1 diabetes subtype, glycated hemoglobin (HbA1c) level, CV of blood glucose levels and history of severe hypoglycemia requiring medical treatment were significant independent variables predicting the presence of hypoglycemia unawareness. The glucose CV and a history of hypoglycemia unawareness were significant independent variables predicting severe hypoglycemia requiring medical treatment. In stratified analyses of patients divided into four groups according to glucose CV and HbA1c levels, the high-glucose-CV/low-HbA1c group had the highest odds ratios for hypoglycemia unawareness (2.60) and severe hypoglycemia requiring medical treatment (2.55). CONCLUSIONS: The ambulant glucose CV correlated with both hypoglycemia unawareness and severe hypoglycemia. Patients with high glucose CV and low HbA1c are at high risk of such adverse events, and their treatment strategies should be reviewed.

A sensor augmented pump may improve awareness of hypoglycemia and quality of life in Japanese patients with type 1 diabetes mellitus.

OBJECTIVE: Sensor-augmented pump (SAP) therapy reportedly improves glycemic control and quality of life. However, there is limited information on changes in awareness of hypoglycemia and quality of life (QOL) after starting SAP therapy in Japanese patients with type 1 diabetes. The aim of this study was to evaluate glycemic control, awareness of hypoglycemia, and QOL after initiation of SAP therapy in these patients. METHODS: The study included 20 patients with type 1 diabetes who started SAP therapy. HbA1c levels, values derived from continuous glucose monitoring [including percentages of time in target range (70-180 mg/dL), time below range (< 70 mg/dL), and time above range (> 180 mg/dL)], the Diabetes Treatment Satisfaction Questionnaire score, and the Clarke score were compared between baseline and after 3 and 6 months of SAP therapy. RESULTS: There was a significant decrease in HbA1c at 3 and 6 months after starting on the SAP (p < 0.0001). There was also a significant decrease in time above range (> 180 mg/dL) at the two time points (p = 0.0069 and p = 0.0042, respectively). There was no significant change in time below range (< 70 mg/dL). There was a significant reduction in the Clarke score (p = 0.0347 and p = 0.0003, respectively) and a significant increase in the treatment satisfaction score (both p < 0.0001). There was no significant change in any of the three MOS 36-Item Short-Form Health Survey v2 component summary scores. CONCLUSION: SAP therapy was associated with improvement of glycemic control, mainly by reducing hyperglycemia, and patients' satisfaction with treatment.