Background Mortality 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. Methods In 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. Results Of 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). Conclusions Medium-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

Background Severe hypoglycaemia may pose significant risk to individuals with type 2 diabetes (T2D), and evidence surrounding strategies to mitigate this risk is lacking. Methods Data was re-analysed from a previous randomised controlled trial studying the impact of nurse-led intervention on mortality following severe hypoglycaemia in the community. A Cox-regression model was used to identify baseline characteristics associated with mortality and to adjust for differences between groups. Kaplan-Meier curves were created to demonstrate differences in outcome between groups across different variables. Results A total of 124 participants (mean age = 75, 56.5% male) were analysed. In univariate analysis, Diabetes Severity Score (DSS), age and insulin use were baseline factors found to correlate to mortality, while HbA1C and established cardiovascular disease showed no significant correlations. Hazard ratio favoured the intervention (0.68, 95% CI: 0.38–1.19) and in multivariate analysis, only DSS demonstrated a relationship with mortality. Comparison of Kaplan-Meier curves across study groups suggested the intervention is beneficial irrespective of HbA1c, diabetes severity score or age. Conclusion While DSS predicts mortality following severe community hypoglycaemia in individuals with T2D, a structured nurse-led intervention appears to reduce the risk of death across a range of baseline parameters.

BackgroundRecent evidence suggests severe hypoglycaemia may pose a risk of premature mortality to individuals with type 2 diabetes. Evidence surrounding strategies to mitigate this risk is currently lacking as is evidence regarding risk stratification of such patients. MethodsWe performed a post-hoc analysis from a previously published RCT studying the impact of a structured nurse led intervention following severe hypoglycaemia. A Cox regression model was used to identify baseline characteristics associated with increased mortality and to adjust for differences between study groups. Kaplan Meier (KM) curves were created to demonstrate differences in outcome between study groups across a number of variables.Results124 participants (mean age 75, 57% male) were included in analysis. Diabetes severity score, age and insulin use were found to correlate with mortality, while other variables including HbA1c and presence of established cardiovascular disease showed no correlations. When comparing KM curves between study groups, the intervention appeared to be beneficial irrespective of glycaemic control, presence of vascular disease, diabetes severity score or age.ConclusionIn this analysis, only diabetes severity score, age and insulin use were significantly associated with death following severe hypoglycaemia in the community. A structured nurse-led intervention appears to reduce the risk of death irrespective of age, co-morbidities or type of treatment. Trial registrationData is taken from a previously published randomised controlled trial with trial registration NCT04422145.

Aims: The aim of this work is to provide in depth characterization of patients with type 2 diabetes (T2D) with severe hypoglycemia and assess the role of structured nurse-led intervention on clinical outcome. Methods: Individuals with T2D and severe hypoglycemia requiring ambulance services assistance were recruited into the study. Participants were randomized into standard arm (n=64), managed using existing pathways, or intervention arm (n=60), receiving nurse-led support for a period of 90 days. A third group did not wish to participate in the interventional study but consented for their data to be collected and were analyzed separately (observational arm; n=36). Results: Of the 160 participants, 88 were men and median age was 77.0 (IQR 69.3-82.0) years. Mean HbA1c±SD was 59.7±16.1 mmol/mol and capillary glucose levels at ambulance crew arrival was 2.2±0.75 mmol/L. HbA1c, smoking status, age and presenting glucose were similar in the standard and intervention arms. 9 participants withdrew or lost to follow-up and were excluded from analysis. Individuals were followed-up for a median of 1350 days (IQR 870-1627) and mortality occurred in 67 participants (44.4%), with cardiovascular events as the leading cause (34%) followed by infections (27%). The number of deaths in the intervention arm was 17 (32%) compared with 31 (50%) in conventionally managed individuals (p=0.047), mainly due to a reduction in cardiovascular mortality [1 (2%) and 11 (18%), respectively; p&lt;0.01]. Individuals in the observational and standard arms had similar mortality rate. Discussion: This pilot study demonstrates that cardiovascular events and infections are the main cause of mortality following severe hypoglycemia in the community requiring ambulance services assistance. A structured nurse-led intervention for 3 months reduces mortality primarily due to a decrease in cardiovascular events. Disclosure S. Pearson: Speaker's Bureau; Self; Novo Nordisk Inc. K. Kulavarasalingam: None. P. Baxter: None. A.K. Mitchell-Gears: Other Relationship; Self; Heart Research UK. B.A. Whittam: None. R. Ajjan: Consultant; Self; Abbott. Research Support; Self; Abbott, LifeScan, Inc.