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...

全面介紹

書目詳細資料
Main Authors: Levy, J, Davies, M, Holman, R
格式: Journal article
出版: Elsevier 2017
_version_ 1826300649874128896
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 [&lt;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 [&lt;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
work_keys_str_mv AT levyj continuousglucosemonitoringdetectedhypoglycaemiainthetreatingtotargetintype2diabetestrial4t
AT daviesm continuousglucosemonitoringdetectedhypoglycaemiainthetreatingtotargetintype2diabetestrial4t
AT holmanr continuousglucosemonitoringdetectedhypoglycaemiainthetreatingtotargetintype2diabetestrial4t