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| Name | Class |
|---|---|
| Centre for Research and Technology Hellas | OTHER |
| University of Ioannina | OTHER |
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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).
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| periodic use of Continuous Glucose Monitoring (CGM) | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from the Primary Care Services or the Outpatient Department of the Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George E, Dafoulas | Contact | +306957830903 | gdafoulas@med.uth.gr | |
| Alexandra Bargiota | Contact | abargio@med.uth.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa | Recruiting | Larissa | Thessaly | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26254702 | Background | Pazos-Couselo M, Garcia-Lopez JM, Gonzalez-Rodriguez M, Gude F, Mayan-Santos JM, Rodriguez-Segade S, Rodriguez-Garcia J, Casanueva F. High incidence of hypoglycemia in stable insulin-treated type 2 diabetes mellitus: continuous glucose monitoring vs. self-monitored blood glucose. Observational prospective study. Can J Diabetes. 2015 Oct;39(5):428-33. doi: 10.1016/j.jcjd.2015.05.007. Epub 2015 Aug 5. | |
| 23589542 |
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The IPD are going to be shared within the provisions of the European Commission Grant Agreement and Consortium Agreement of the Study
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| 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 |
| Background |
| Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013 May;36(5):1384-95. doi: 10.2337/dc12-2480. Epub 2013 Apr 15. |