Abstract
BackgroundMortality in individuals with diabetes with severe hypoglycemia requiring ambulance services intervention is high and it is unclear whether this is modifiable. Our aim was to characterise this high-risk group and assess the impact of nurse-led intervention on mortality.MethodsIn this single centre study, patients with diabetes and hypoglycemia requiring ambulance call out were randomized to nurse led support (intensive arm) or managed using existing pathways (standard arm). A third group agreed to have their data collected longitudinally (observational arm). The primary outcome was all-cause mortality comparing intensive with combined standard and observational arms as well as standard arm alone.ResultsOf 828 individuals identified, 323 agreed to participate with 132 assigned to intensive, 130 to standard and 61 to observational arms. Mean follow up period was 42.6 ± 15.6 months. Mortality in type 1 diabetes (n = 158) was similar across study arms but in type 2 diabetes (n = 160) this was reduced to 33% in the intensive arm compared with 51% in the combined arm (p = 0.025) and 50% in the standard arm (p = 0.06). Cardiovascular deaths, the leading cause of mortality, was lower in the intensive arm compared with combined and standard study arms (p < 0.01).ConclusionsMedium-term mortality following severe hypoglycemia requiring the assistance of emergency services is high in those with type 2 diabetes. In individuals with type 2 diabetes, nurse-led individualized intervention reduces cardiovascular mortality compared with standard care. Large-scale multicentre studies are warranted to further investigate this approach.Trial registration The trial was retrospectively registered on http://www.clinicaltrials.gov with reference NCT04422145
Highlights
Mortality in individuals with diabetes with severe hypoglycemia requiring ambulance services inter‐ vention is high and it is unclear whether this is modifiable
Intensive glycemic control increases the risk of hypoglycemia, which is associated with adverse clinical outcome [9,10,11,12]
While subsequent analysis failed to conclusively demonstrate that low glucose levels caused the higher mortality in intensively-treated patients, hypoglycemia was generally associated with increased mortality in the study population [14]
Summary
Mortality in individuals with diabetes with severe hypoglycemia requiring ambulance services inter‐ vention is high and it is unclear whether this is modifiable. Intensive glycemic control increases the risk of hypoglycemia, which is associated with adverse clinical outcome [9,10,11,12]. While subsequent analysis failed to conclusively demonstrate that low glucose levels caused the higher mortality in intensively-treated patients, hypoglycemia was generally associated with increased mortality in the study population [14]. A study in type 2 diabetes subjects has shown that low blood glucose levels, under controlled conditions, increases thrombosis risk for up to 1 week, providing one explanation for the relationship between cardiovascular death and hypoglycemia [16]. Large scale studies and anecdotal reports have shown associations between antecedent hypoglycemia and vascular mortality [12, 18−21]
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