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Hypoglycemia Requiring Emergency Services Intervention: Patient Characteristics, Outcome and Cardiovascular Risk Profile

NCT04422145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2020-06-09

No results posted yet for this study

Summary

Patients who suffer hypoglycaemia in the community requiring the services of an ambulance are known to have a high short term mortality based on previous work. What is not known is the demographics of this group and also what the cause of death was for individuals whom unfortunately passed away in the time following ambulance callout. Importantly, studies looking at interventions to reduce poor outcomes in this group are lacking. The investigators conducted a pilot trial with the main goals to:

1. Characterise this group in more detail and ascertain what was recorded as cause of death in those whom passed away in the months/years following community hypoglycaemia
2. Ascertain if a simple nurse led intervention, focusing on educating participants on avoidance of hypoglycaemia, could improve outcome.

Conditions

Interventions

BEHAVIORAL

Structured nurse led intervention programme

A diabetes research nurse, over a period of 12 months, provided a structured education programme to participants focussing on the avoidance of hypoglycaemia and the treatment of this if/when it occurred.

OTHER

Standard care

Participants continue on their current diabetes care plan and are looked after by their usual diabetes care provider

Sponsors & Collaborators

  • Yorkshire Ambulance Service NHS Trust

    collaborator OTHER_GOV

  • LifeScan

    collaborator INDUSTRY

  • University of Leeds

    lead OTHER

Principal Investigators

  • Ramzi Ajjan, PHD · Professor of metabolic medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2017-12-18
Completion
2018-12-18

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04422145 on ClinicalTrials.gov