Certain groups of patients with Type 2 Diabetes Mellitus (T2DM) appear to have higher risk of hypoglycaemia. Periodic use of Continuous Glucose Monitoring (CGM), has been suggested as a method to detect hypoglycaemia events in certain subgroups of patients with high risk of hypoglycaemia. The aim of the present study is to contribute to the identification of subgroups of T2DM patients with high risk of hypoglycemia events, based on periodic use of Continuous Glucose Monitoring (CGM).
Some studies successfully achieved standard glycemic targets without increased hypoglycaemia in older adults and other groups of patients with high risk of hypoglycaemia events. However these trials usually exclude adults with poor health and comorbidities, when they support the concept that intensive strategies for selected individuals can be effective and safe. The compendium of results from these and other published analyses suggests that although some patients may benefit from tighter targets, many are unable to reach these targets, and aggressive therapy may be harmful to some patients without the benefit of reducing complications. Although avoidance of hypoglycaemia is a critical treatment strategy, overall glucose control remains an important goal. The present treatment guidelines fail to locate the proper subgroup of patients with Type 2 Diabetes Mellitus (T2DM), that could be benefited of glycemic control balanced with the adverse effects of glucose-lowering medications and a patient's age, overall health status, and functional and intellectual capacity. The aim of the present study is to contribute to the identification of subgroups of T2DM patients with high risk of hypoglycemia events, based on periodic use of Continuous Glucose Monitoring (CGM).
Study Type
OBSERVATIONAL
Enrollment
75
Identification of hypoglycaemia events, based on use of Continuous Glucose Monitoring (CGM) for at least 14days, in subgroups of T2DM patients with high risk of hypoglycaemia
Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa
Larissa, Thessaly, Greece
RECRUITINGDetection of hypoglycaemic events
Time frame: frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Glucose Management Indicator (GMI) correlation with HbA1c
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Glycaemic control (Time in Range)
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
EQ5D (Generic HRQL)
Generic Health Related Quality of Life (HRQL)
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Problem Areas in Diabetes scale - PAID (Disease specific HRQL)
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Assess the risk of hypoglycemia with Hypoglycemia Patient Questionnaire
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Registry of hypoglycaemia events in patients with T2DM treated with insulin and insulin secretagogues
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
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