ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2016
Hypoglycemia Event Rates: A Comparison Between Real-World Data and Randomized Controlled Trial Populations in Insulin-Treated Diabetes.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers, 1 of them a synthesis that pooled it.
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Who cites it
68 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative Effectiveness and Safety of High-Intensity Focused Ultrasound for Uterine Fibroids: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2021Pooled it
- No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial.Diabetes, obesity & metabolism · 2021Trial
- Early Postoperative Basal Insulin Therapy versus Standard of Care for the Prevention of Diabetes Mellitus after Kidney Transplantation: A Multicenter Randomized Trial.Journal of the American Society of Nephrology : JASN · 2021Trial
- Efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in patients with insufficiently controlled type 2 diabetes: results of the phase IV COBALTA trial.BMJ open diabetes research & care · 2020Trial
- A pragmatic study of mid-mixture insulin and basal insulin treatment in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic medications: A lesson from real-world experience.Diabetes, obesity & metabolism · 2020Trial
- Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial.Diabetologia · 2020Trial
- Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16).Applied health economics and health policy · 2019Trial
- Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2.Diabetes, obesity & metabolism · 2019Trial
- Effects of β-blockers on all-cause mortality in patients with type 2 diabetes and coronary heart disease.Diabetes, obesity & metabolism · 2017Trial
- Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial.BMJ (Clinical research ed.) · 2017Trial
- Effect of hypoglycemia on the diameter of cerebral vasculature in vivo and cerebral ischemia-reperfusion injury in mice.Experimental neurology · 2026Article
- Improved Glycaemic Control with IDegLira in Chinese Adults with Type 2 Diabetes in Real-World Settings: A Retrospective, Database Cohort Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Review
- Time-divided hypoglycemia management derived by continuous glucose monitoring may reduce microvascular diseases in type 2 diabetes patients.Endocrine · 2025Article
- Investigation of Severe Hypoglycemia Risk Among Patients with Diabetes Treated with Ultra-Rapid Lispro in Japan.Advances in therapy · 2025Observational
- Relationship Between Sensor-Detected Hypoglycemia and Patient-Reported Hypoglycemia in People With Type 1 and Insulin-Treated Type 2 Diabetes: The Hypo-METRICS Study.Diabetes care · 2024Article
- Severe (level 3) hypoglycaemia occurrence in a real-world cohort of adults with type 1 or 2 diabetes mellitus (iNPHORM, United States).Diabetes, obesity & metabolism · 2023Article
- The Role of Real-World Evidence in Treatment Decision-Making, Regulatory Assessment, and Understanding the Perspectives of People with Type 2 Diabetes: Examples with Gliclazide MR.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023Article
- Epidemiological, Social and Economic Burden of Severe Hypoglycaemia in Patients with Diabetes Mellitus in Portugal: A Structured Literature Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023Review
- The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia.Frontiers in pharmacology · 2023Review
8 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHypoglycemia is the most common adverse effect of diabetes therapy, particularly insulin treatment. Hypoglycemia is associated with considerable clinical and economic burden, and may be under-reported. The aim of this study was to com pare the frequency of hypoglycemic events reported in real-world settings with those reported in clinical trials.
methodsWe conducted a structured literature review in PubMed to identify hypoglycemic event rates in patients with type 1 diabetes mellitus (T1DM) and insulin-treated type 2 diabetes mellitus (T2DM) from real-world data (RWD) and randomized controlled trials (RCTs). The search was restricted to English language, full-text publications from 2010 onwards, reporting on treatment of T1DM or T2DM with basal only, basal-bolus, or premix insulin.
resultsThe final dataset included 30 studies (11 RWD studies and 19 RCTs). Six studies (RWD, n = 2; RCT, n = 4) reported hypoglycemia event rates in people with T1DM. For all reported categories of hypoglycemia (severe, non-severe, and nocturnal), rates were consistently higher in RWD studies compared with RCTs. Twenty-five studies (RWD, n = 10; RCT, n = 15) reported hypoglycemia event rates in people with insulin-treated T2DM. For T2DM basal-oral therapy; the highest rates were observed in RWD studies, although there was an overlap with RCT rates. For basal-bolus therapy, there was considerable between-study variability but higher rates of severe and non-severe hypoglycemia were generally observed in RWD studies. For T2DM premix insulin, reported rates of hypoglycemia in RWD studies and RCTs were similar.
conclusionWe found that higher rates of hypoglycemia are observed in real-world settings compared with clinical trial settings, although there is a large degree of overlap. Due to the inherent constraints of RCTs, they are likely to underestimate the burden of hypoglycemia in clinical practice. Further, high-quality RWD are needed to determine a more accurate incidence of hypoglycemia in clinical practice.
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