Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T)
<h4>Aims</h4> <p>Hypoglycaemia is a significant risk in insulin treated type 2 diabetes and has been associated with future risk of cardiovascular events. We compared the frequency of low-glucose events using continuous glucose monitoring (CGM) with that of self-reported hypoglyce...
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格式: | Journal article |
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Elsevier
2017
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_version_ | 1826300649874128896 |
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author | Levy, J Davies, M Holman, R |
author_facet | Levy, J Davies, M Holman, R |
author_sort | Levy, J |
collection | OXFORD |
description | <h4>Aims</h4> <p>Hypoglycaemia is a significant risk in insulin treated type 2 diabetes and has been associated with future risk of cardiovascular events. We compared the frequency of low-glucose events using continuous glucose monitoring (CGM) with that of self-reported hypoglycemic events at the end of the first and third years of the Treating to Target in Type 2 Diabetes Trial (4-T), which compared biphasic, prandial and basal insulin regimens added to sulfonylurea and metformin.</p> <h4>Methods</h4> <p>CGM using a Medtronic Gold system was performed in a subgroup of 4-T participants. CGM detected low-glucose events were defined at thresholds of ≤3.0 (CGM3.0) and ≤2.2 (CGM2.2) mmol/l.</p> <h4>Results</h4> <p>Of the 110 participants, 106 and 70 had CGM analysable data at the end of years 1 and 3 respectively. In both years, the frequency of CGM detected low glucose events was several fold higher than that of self-reported hypoglycaemia (symptoms with blood glucose less than 3.1 mmol/l [<56 mg/dl]). At the end of the first year, CGM3.0 and CGM2.2 mean (95%CI) event frequencies, expressed at events per participant per year, were 120 (85, 155) and 41 (21, 61) compared with 17 (8, 29) self-reported events during CGM, each p=0.001. The disparity at the end of the third year was similar.</p> <h4>Conclusions</h4> <p>These data demonstrate the likely under-reporting of hypoglycaemia and of potential hypoglycaemia unawareness in clinical trials. The clinical implications of these findings need to be explored further.</p> |
first_indexed | 2024-03-07T05:20:25Z |
format | Journal article |
id | oxford-uuid:deafd8b9-1446-4a2e-bfbe-f8be46e8e30b |
institution | University of Oxford |
last_indexed | 2024-03-07T05:20:25Z |
publishDate | 2017 |
publisher | Elsevier |
record_format | dspace |
spelling | oxford-uuid:deafd8b9-1446-4a2e-bfbe-f8be46e8e30b2022-03-27T09:34:02ZContinuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:deafd8b9-1446-4a2e-bfbe-f8be46e8e30bSymplectic Elements at OxfordElsevier2017Levy, JDavies, MHolman, R <h4>Aims</h4> <p>Hypoglycaemia is a significant risk in insulin treated type 2 diabetes and has been associated with future risk of cardiovascular events. We compared the frequency of low-glucose events using continuous glucose monitoring (CGM) with that of self-reported hypoglycemic events at the end of the first and third years of the Treating to Target in Type 2 Diabetes Trial (4-T), which compared biphasic, prandial and basal insulin regimens added to sulfonylurea and metformin.</p> <h4>Methods</h4> <p>CGM using a Medtronic Gold system was performed in a subgroup of 4-T participants. CGM detected low-glucose events were defined at thresholds of ≤3.0 (CGM3.0) and ≤2.2 (CGM2.2) mmol/l.</p> <h4>Results</h4> <p>Of the 110 participants, 106 and 70 had CGM analysable data at the end of years 1 and 3 respectively. In both years, the frequency of CGM detected low glucose events was several fold higher than that of self-reported hypoglycaemia (symptoms with blood glucose less than 3.1 mmol/l [<56 mg/dl]). At the end of the first year, CGM3.0 and CGM2.2 mean (95%CI) event frequencies, expressed at events per participant per year, were 120 (85, 155) and 41 (21, 61) compared with 17 (8, 29) self-reported events during CGM, each p=0.001. The disparity at the end of the third year was similar.</p> <h4>Conclusions</h4> <p>These data demonstrate the likely under-reporting of hypoglycaemia and of potential hypoglycaemia unawareness in clinical trials. The clinical implications of these findings need to be explored further.</p> |
spellingShingle | Levy, J Davies, M Holman, R Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T) |
title | Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T) |
title_full | Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T) |
title_fullStr | Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T) |
title_full_unstemmed | Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T) |
title_short | Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T) |
title_sort | continuous glucose monitoring detected hypoglycaemia in the treating to target in type 2 diabetes trial 4 t |
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