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The Ambulance-Hypo Study

Innovative hypoglycaemia pathway for self-care at home and admission avoidance: a partnership approach with a regional ambulance trust

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56314240
Enrollment
216
Registered
2016-02-10
Start date
2016-03-01
Completion date
Unknown
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of hypoglycaemia in people with diabetes Nutritional, Metabolic, Endocrine

Interventions

Patients are randomised to the intervention arm (intervention from a diabetes nurse) or the control arm (GP referral). The intervention involves ambulance staff from East Midlands Amb

Sponsors

University of Leicester (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Willing and able to give informed consent 2. Age 18 years and older 3. Able to speak and read English 4. Paramedic assessment of a hypoglycaemic event on the basis of blood glucose reading of <4.0 mmol/l 5. Lives in Northamptonshire or Lincolnshire 6. Responsible for their own care and/or medication

Exclusion criteria

Exclusion criteria: 1. Unwilling or not able to give informed consent 2. Aged under 18 years 3. Not able to speak and read English 4. Lives outside Northamptonshire and Lincolnshire 5. Not responsible for their own care and/or their medication 6. Previously referred to the present study 7. Admitted to hospital for more than 2 days 8. Registered with a GP outside of the Northamptonshire or Lincolnshire CCGs (i.e., Nene and Corby, West Lincolnshire, East Lincolnshire, South West Lincolnshire and South Lincolnshire, respectively)

Design outcomes

Primary

MeasureTime frame
Documented evidence in the patient’s notes (practice notes or those maintained by DSNs) that the hypoglycaemic episode was discussed (within 4 weeks of the call-out) during a telephone consultation or a face-to-face consultation with a Health Care Professional (HCP), and that advice was given and/or changes made to their medication

Secondary

MeasureTime frame
1. Patient’s satisfaction with the treatment they have received (Diabetes Treatment Satisfaction Questionnaire (Bradley, 1994)) 4 weeks after consent 2. Patient’s knowledge of DVLA driving regulations relating to hypoglycaemia (unvalidated questionnaire) 4 weeks after consent 3. Patient’s fear of hypoglycaemia, Fear of Hypoglycaemia Scale (Cox et al., 1987) 4 weeks after consent 4. Patient’s quality of life EQ5D (The EuroQol Group, 1990) 4 weeks after consent 5. Rates of CVD and CVD-related mortality (rates of all-cause mortality) extracted from patients medical notes at 12 months after consent 6. Rate of hypoglycaemic episodes requiring repeat ambulance attendance (recorded by ambulance service) collected at 12 months after consent 7. Rate of hypoglycaemic episodes requiring repeat ambulance attendance and conveyance to hospital (including information on whether or not admitted) (recorded by ambulance service) collected at 12 months after consent

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026