Reduction in cardiovascular mortality following severe hypoglycemia in individuals with type 2 diabetes: the role of a pragmatic and structured intervention : Structured intervention for community hypoglycemia

Sam M Pearson, Beverley Whittam, Kavita Kulavarasalingam, Amelia Mitchell-Gears, Cathyrn James, Ramzi A Ajjan, Sam M Pearson, Beverley Whittam, Kavita Kulavarasalingam, Amelia Mitchell-Gears, Cathyrn James, Ramzi A Ajjan

Abstract

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.

Keywords: Cardiovascular mortality; Community hypoglycemia; Structured intervention.

Conflict of interest statement

R.A.A received Institutional Research Grants from Abbott, Bayer, Eli Lilly, LifeScan, NovoNordisk, Roche, Takeda as well as honoraria/education support/consultancy from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, NovoNordisk and Takeda. All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
A diagrammatic depiction of trial design. Out of 828 diabetes patients suffering severe hypoglycemia, 323 agreed to participate in the study. A total of 61 participants did not wish to be involved in an interventional study and were entered into an observational arm. The remaining 262 participants were randomized to structured nurse led intervention or standard care
Fig. 2
Fig. 2
Kaplan Meier survival curves for all-cause mortality. Participants were followed up for a mean of 42.6 ± 15.6 months. a All individuals in the study. b Individuals with type 1 diabetes. c Individuals with type 2 diabetes. The green line denotes participants in the intensive arm of the study, the blue line those in the standard arm and the red line the observational arm

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Source: PubMed

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