Hypoglycemia is a major barrier to achieving the glycemic goal in patients with type 2 diabetes. In particular, severe hypoglycemia, which is defined as an event that requires the assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions, is a serious clinical concern in patients with diabetes. If severe hypoglycemia is not managed promptly, it can be life threatening. Hypoglycemia-associated autonomic failure (HAAF) is the main pathogenic mechanism behind severe hypoglycemia. Defective glucose counter-regulation (altered insulin secretion, glucagon secretion, and an attenuated increase in epinephrine during hypoglycemia) and a lack of awareness regarding hypoglycemia (attenuated sympathoadrenal activity) are common components of HAAF in patients with diabetes. There is considerable evidence that hypoglycemia is an independent risk factor for cardiovascular disease. In addition, hypoglycemia has a significant influence on the quality of life of patients with diabetes. To prevent hypoglycemic events, the setting of glycemic goals should be individualized, particularly in elderly individuals or patients with complicated or advanced type 2 diabetes. Patients at high-risk for the future development of severe hypoglycemia should be selected carefully, and intensive education with reinforcement should be implemented.
Autonomic Nervous System/physiopathology ; Biological Markers/blood ; Blood Glucose/*drug effects/metabolism ; Diabetes Mellitus, Type 2/blood/complications/diagnosis/*drug therapy/physiopathology ; Health Knowledge, Attitudes, Practice ; Humans ; Hypoglycemia/blood/chemically induced/epidemiology/physiopathology/*prevention & control ; Hypoglycemic Agents/*adverse effects ; Incidence ; Patient Education as Topic ; Prevalence ; Prognosis ; Risk Assessment ; Risk Factors

BACKGROUND/AIMS: Based on the results of well designed clinical studies, intensive insulin therapy has been established to improve glycemic control in newly diagnosed diabetes. However, discrepancies exist between the findings of clinical trials and experiences in general practice. Furthermore, the efficacy of an early insulin therapy (EIT) - commonly used in general practice - on long-term glycemic control has not been established. Therefore, we evaluated the effects of EIT on pancreatic beta-cell function and glycemic control using insulin-based methods widely employed in general practice. METHODS: We performed a retrospective cohort study that initially involved reviewing patients' medical records. Following a thorough review, 61 patients who received either biphasic or prandial EIT at the time of diagnosis were enrolled. We then evaluated changes in beta-cell function and glycemic control during a 48-month follow-up period. RESULTS: Mean HbA1c decreased significantly as a result of EIT from 10.7 +/- 1.8% to 6.2 +/- 1.1% (p < 0.001). On average, 2.6 months was required to achieve an HbA1c value < 7%. EIT significantly improved the insulinogenic index. Glycemic control was well maintained for 48 months. More than 70% of patients were able to maintain glycemic control following lifestyle modifications or treatment with oral antidiabetic drugs. No significant differences were identified between patients receiving biphasic EIT and prandial EIT in terms of glycemic control or pancreatic beta-cell function. CONCLUSIONS: Our results suggest that regardless of the method of delivery, EIT significantly improves beta-cell function and facilitates long-term glycemic control in patients with newly diagnosed type 2 diabetes mellitus.
Administration, Oral ; Adult ; Blood Glucose/metabolism ; Cohort Studies ; Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy/*physiopathology ; Female ; Hemoglobin A, Glycosylated/metabolism ; Humans ; Hypoglycemic Agents/administration & dosage ; Insulin/administration & dosage/*therapeutic use ; Insulin Resistance ; Insulin-Secreting Cells/*drug effects/*physiology ; Male ; Middle Aged ; Retrospective Studies