Incidence of Hypoglycaemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Incidence of Hypoglycemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus: Continuous Glucose Monitoring vs. Self-Monitored Blood Glucose

Conditions
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Diabetes Mellitus Type 2 With Hypoglycemia

Intervention / Treatment
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* Device: periodic use of Continuous Glucose Monitoring (CGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being older than 40 years of age having type 2 diabetes for at least 1 year being on insulin therapy for at least 3 months before recruitment having the ability to perform self-monitoring being able to wear a CGM system during 2 weeks having a stable metabolic situation, defined as having no need to add new treatments or make any changes in insulin dosage of more than 10% in the preceding 2 months Exclusion Criteria: Having severe hearing or vision problems or any other acute or chronic condition that would limit the ability of the user to participate in the study Being institutionalised or person not capable of giving consent Pregnancy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: periodic use of Continuous Glucose Monitoring (CGM)|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of hypoglycaemic events |  | frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Management Indicator (GMI) correlation with HbA1c |  | 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks | 
| Glycaemic control (Time in Range) |  | 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks | 
| EQ5D (Generic HRQL) | Generic Health Related Quality of Life (HRQL) | 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks | 
| Problem Areas in Diabetes scale - PAID (Disease specific HRQL) |  | 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks | 
| Assess the risk of hypoglycemia with Hypoglycemia Patient Questionnaire |  | 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 |  | 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks |