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

Abstract

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.

Nocturnal Hypoglycaemia in Patients with Diabetes Mellitus: Database Analysis of a Cohort Using Telemedicine Support for Self-Monitoring of Blood Glucose over a 10-Year-Long Period

“…Regarding patients’ distribution according to antihyperglycaemic therapy, the majority (78.5%) was only on insulin treatment while an additional part of the patients (8.8%) was treated with insulin plus oral drugs in combination. These results are consistent with former publications indicating that insulin treatment is a major risk factor for hypoglycaemia, particularly for nocturnal hypoglycaemia [ 2 , 3 , 8 , 17 , 36 ].…”

“…Nocturnal hypoglycaemia is particularly important in patients with diabetes as the clinical consequences of lower blood glucose values may be even more serious than those observed daytime. Although nocturnal hypoglycaemic episodes are regularly registered and published—with other outcome parameters—in randomized, controlled clinical trials conducted in patients with type 1 or type 2 diabetes, real-world data about their occurrence are limited [ 16 , 17 ]. As SMBG has increasingly become popular in daily clinical practice, important real-world aspects could be expected from an analysis of a large database of patients using SMBG regularly.…”

Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future

“…Consequently, patients with diabetes must be carefully managed (20). This includes addressing poor glycaemic control which increases morbidity, mortality and costs (21)(22)(23). Whilst only a minority of patients with diabetes are receiving insulin, which can be up to 40% of patients with diabetes in lowand middle-income countries (LMICs) (24)(25)(26), long-acting insulin analogues were developed to reduce the risk of hypoglycaemia, including nocturnal hypoglycaemia.…”

Expert Panel Guidance and Narrative Review of Treatment Simplification of Complex Insulin Regimens to Improve Outcomes in Type 2 Diabetes

“…However, in older individuals, where the risk of hypoglycaemia and its consequences occurring is high, the costs of aggressive lowering of HbA 1c may outweigh the benefits of tight glycaemic control on these complications and can increase the risk of hypoglycaemia, weight gain and treatment burden [23,24]. Hypoglycaemia is not only associated with difficulties in adherence and reduced QoL but can also incur significant healthcare system expenditure [25][26][27].…”