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Ambulance 'Hypos Can Strike Twice' Study

NCT04243200 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5015

Last updated 2021-09-30

No results posted yet for this study

Summary

This study will assess the effectiveness the "Hypos can strike twice" intervention on people with diabetes experiencing hypoglycaemia (or "hypo", meaning low blood sugar). The intervention should help prevent recurrence of "hypos", improve patients' future health, reduce calls to ambulance services and thus reduce NHS pressures and costs.

Hypoglycaemia affects increasing numbers of people with diabetes. It is a side effect of treatment with insulin or certain tablets, where blood glucose (sugar) falls causing the brain to malfunction. In mild cases this can lead to sweating, drowsiness and confusion; in more severe cases, coma can occur needing medical assistance for recovery, and if prolonged can be fatal. It results in 1% of calls to ambulance services.

The "Hypos can strike twice" intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a "Hypos can strike twice" information booklet which they can read when they recover.

Universities of Lincoln and Leicester are working with East Midlands Ambulance Service NHS Trust and patient groups on this study. The "Hypos can strike twice" intervention has now been implemented by ambulance services in Leicester, Northamptonshire, Nottinghamshire, Derbyshire and Lincolnshire from October 2018-May 2019.

The investigators will analyse data from the ambulance services before, during and after the introduction of the 'Hypos can strike twice' intervention to evaluate the effect of the intervention on repeat ambulance calls and attendances for hypoglycaemia and the costs and consequences of implementing it. The investigators will also interview/survey ambulance staff who provided the intervention and patients who received it, to understand how and why it works (or does not) and how, if it works, it could be scaled up over a larger geographical area. The duration of this study is 1 year.

Conditions

Interventions

OTHER

Hypos can strike twice

The "Hypos can strike twice" intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a "Hypos can strike twice" information booklet which they can read when they recover.

Sponsors & Collaborators

  • University of Lincoln

    lead OTHER

Principal Investigators

  • Niro Siriwardena · University of Lincoln, UK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-04-30
Completion
2021-04-30

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 NCT04243200 on ClinicalTrials.gov