Hypoglycaemic events in patients with type 2 diabetes in the United Kingdom: associations with patient-reported outcomes and self-reported HbA1c

Mitchell, Beth; Vietri, Jeffrey; Zagar, Anthony; Curtis, Bradley; Reaney, Matthew

doi:10.1186/1472-6823-13-59

Cited by 38 publications

(47 citation statements)

References 39 publications

(39 reference statements)

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“…Older age, diabetes duration, the presence of comorbidities, treatment intensification and insulin treatment have all been associated with an increased risk of hypoglycaemia [3-5, 18, 19]. Of particular importance are recent findings demonstrating an association between SH and insulin use [3-5], even in patients who do not achieve intensive glucose targets [6, 7, 20]. The current investigation presents blood biomarkers which are associated with SH and a failure to achieve an HbA 1c level of <6.0 (42 mmol/mol) in the setting of intensive treatment, thereby providing potential tools to identify type 2 diabetes patients who can achieve lower HbA 1c targets without a significant risk of SH.…”

Section: Discussionmentioning

confidence: 99%

Biomarkers related to severe hypoglycaemia and lack of good glycaemic control in ACCORD

et al. 2015

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Aims/hypothesis In patients with diabetes, intensive glycaemic control reduces microvascular complications. However, severe hypoglycaemia frequently complicates intensive glycaemic control. Blood biomarkers that predict successful intensification of glycaemic control in patients with type 2 diabetes without the development of severe hypoglycaemia would advance patient care. In patients who received intensive treatment for type 2 diabetes from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, we hypothesised that insulin deficiency and islet autoantibodies would be associated with severe hypoglycaemia and failure to achieve near- normal glycaemia (HbA1c <6.0% [42 mmol/mol]). Methods A nested case–control design was used. Cases (n=326) were defined as participants having severe hypoglycaemia and failure to achieve an HbA1c level of <6.0% (42 mmol/mol) prior to the ACCORD transition or death. Controls (n=1075) were those achieved an HbA1c level of <6.0% (42 mmol/mol) prior to the ACCORD transition or death without severe hypoglycaemia. Each case was matched (for race, age and BMI) by up to four controls. Baseline insulin deficiency (fasting C-peptide ≤0.15 nmol/l) and islet autoantibodies (glutamic acid decarboxylase [GAD], tyrosine phosphatase-related islet antigen 2 [IA2], insulin [IAA] and zinc transporter 8 [ZnT8]) were measured. Conditional logistic regression with and without adjustment for age, BMI and diabetes duration was used on the full cohort and after removal of patients who died and their respective controls. Results Severe hypoglycaemia accompanied by an inability to achieve an HbA1c level of <6.0% (42 mmol/mol) was associated with insulin deficiency (adjusted OR 23.2 [95% CI 9.0, 59.5], p<0.0001), the presence of IAA autoantibodies or baseline insulin use (adjusted OR 3.8 [95% CI 2.7, 5.3], p<0.0001), GAD autoantibodies (OR 3.9 [95% CI 2.5, 6.0], p<0.0001), IA2 autoantibodies (OR 16.7 [95% CI 3.9, 71.6], p=0.0001), and ZnT8 autoantibodies (adjusted OR 3.9 [95% CI 1.2, 12.4], p=0.02). Conclusions C-peptide and islet autoantibodies may serve as biomarkers to predict the risk of severe hypoglycaemia during intensification of type 2 diabetes treatment. Trial registration ClinicalTrials.gov NCT00000620 (original ACCORD study)

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Section: Discussionmentioning

confidence: 99%

Biomarkers related to severe hypoglycaemia and lack of good glycaemic control in ACCORD

et al. 2015

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“…19,30 However, it has also been reported that, despite the fact that hypoglycaemia results in poorer adherence, participants experiencing hypoglycaemia achieved lower HbA1c levels than those who did not experience hypoglycaemia. 19,30 However, it has also been reported that, despite the fact that hypoglycaemia results in poorer adherence, participants experiencing hypoglycaemia achieved lower HbA1c levels than those who did not experience hypoglycaemia.…”

Section: Hba1c Target Achievement At 12 Weeksmultivariate Modelmentioning

confidence: 99%

The Diabetes Unmet Need with Basal Insulin Evaluation (DUNE) study in type 2 diabetes: Achieving HbA1c targets with basal insulin in a real‐world setting

Meneghini

Mauricio

Orsi

et al. 2019

Diabetes Obesity Metabolism

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Aims To describe in a real‐world setting the achievement of physician‐selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement. Materials and methods A 12‐week, prospective, single‐arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP‐1 receptor agonists. Results Individualized targets for almost all of the 3139 evaluable participants (99.7%) had been set by their physicians, with 57% of participants having HbA1c targets between 7.0% and <7.5% (53 and <58 mmol/mol). By week 12, 28% and 27% of newly and previously initiated participants, respectively, achieved individualized HbA1c targets with modest average increases in daily insulin dose of 9 and 5 U (0.10 and 0.06 U/kg), respectively, from baseline (14 and 23 U [0.17 and 0.29 U/kg], respectively). Overall, 16% of participants experienced at least one episode of hypoglycaemia. Both the incidence and frequency of hypoglycaemia, but not the severity, were positively associated with a higher likelihood of achieving individualized HbA1c targets (P < 0.05). Conclusions In this prospective real‐world study, most participants using basal insulin did not achieve the individualized HbA1c targets set by their physicians. Participants who experienced symptomatic hypoglycaemia were more likely to achieve HbA1c targets than those who did not.

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“…Furthermore, hypoglycaemia has a well‐established significant negative impact on well‐being, productivity and quality of life (QOL) . Recent studies have confirmed that, in addition to decreased overall health‐related QOL, hypoglycaemia can negatively impact physical and mental well‐being, limit mobility, lead to anxiety and depression, interfere with social activities, result in missed work (absenteeism), impair performance while at work (presenteeism) and decrease overall work productivity . In addition to an economic burden for patients, hypoglycaemia is associated with increased healthcare resource utilization and health‐economic burden .…”

Section: Introductionmentioning

confidence: 99%

Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real‐world studies

Pedersen‐Bjergaard

Alsifri

Aronson

et al. 2018

Diabetes Obesity Metabolism

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Aims Optimal diabetes care requires clear understanding of the incidence of hypoglycaemia in real‐world clinical practice. Current data on hypoglycaemia are generally limited to those reported from randomised controlled clinical trials. The Hypoglycaemia Assessment Tool (HAT) study, a non‐interventional real‐world study of hypoglycaemia, assessed hypoglycaemia in 27 585 individuals across 24 countries. The present study compared the incidence of hypoglycaemia from the HAT study with other similarly designed, large, real‐world studies. Materials and Methods A literature search of PubMed (1995‐2017) for population‐based studies of insulin‐treated patients with type 1 or type 2 diabetes (T1D, T2D), excluding clinical trials and reviews, identified comparable population‐based studies reporting the incidence of hypoglycaemia. Results The 24 comparative studies, including more than 24 000 participants with T1D and more than 160 000 participants with T2D, varied in design, size, inclusion criteria, definitions of hypoglycaemia and method of recording hypoglycaemia. Reported rates (events per patient‐year [PPY]) of hypoglycaemia were higher in patients with T1D than in those with T2D (overall T1D, 21.8‐73.3 and T2D, 1.3‐37.7; mild/non‐severe T1D, 29.0‐126.7 and T2D, 1.3‐41.5; severe T1D, 0.7‐5.8 and T2D, 0.0‐2.5; nocturnal T1D, 2.6‐11.3 and T2D, 0.38‐9.7) and were similar to the ranges found in the HAT study. Conclusions The HAT data on hypoglycaemia incidence were comparable with those from other real‐world studies and indicate a high incidence of hypoglycaemia among insulin‐treated patients. Differences in rates among studies are mostly explained by differences in patient populations and study methodology. The goal of reducing hypoglycaemia should be a target for continued educational and evidence‐based pharmacological interventions.

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Hypoglycaemic events in patients with type 2 diabetes in the United Kingdom: associations with patient-reported outcomes and self-reported HbA1c

Cited by 38 publications

References 39 publications

Biomarkers related to severe hypoglycaemia and lack of good glycaemic control in ACCORD

Biomarkers related to severe hypoglycaemia and lack of good glycaemic control in ACCORD

The Diabetes Unmet Need with Basal Insulin Evaluation (DUNE) study in type 2 diabetes: Achieving HbA1c targets with basal insulin in a real‐world setting

Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real‐world studies

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