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

NCT04422145 | Completed

• 1 other identifier: P1
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Ascertain if a simple nurse led intervention, focusing on educating participants on avoidance of hypoglycaemia, could improve outcome.

Conditions

Diabetes Mellitus; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• All cause mortality at study endpoint with each participant having a minimum follow up of 12 months and the final analysis of data being done 58 months after the first participant was recruited (this is study endpoint.)

  Electronic review of participants records to ascertain if they had passed away during the study

  Through study endpoint, which was 58 months following the recruitment of the first participant and 12 months following the recruitment of the last participant.

Secondary Outcomes (3)

• All cause mortality at 12 months from recruitment.

  12 months

• Analyse cause of death at study endpoint (12 months following recruitment of last participant).

  Study end point defined as 12 months following recruitment of last participant (approximately 40 months from start of study).

• Assessment of differences in mortality rate between type 1 and type 2 diabetes participants

  Study endpoint (12 months following recruitment of last participant.)

Study Arms (3)

Interventional/intensive

ACTIVE COMPARATOR

Participants received a structured nurse led education programme surrounding hypoglycaemia. They were encouraged to use self monitoring of blood glucose (SMBG) and had their diabetes medications adjusted according to this. They also received information on how to avoid hypoglycaemia (including the effects of diet, exercise, alcohol and their medications) and how to treat hypoglycaemia should it occur.

Behavioral: Structured nurse led intervention programme

Standard

PLACEBO COMPARATOR

Participants returned to their standard diabetes care provider with no intervention.

Other: Standard care

Observational

NO INTERVENTION

Participants were happy to have baseline characteristics collected and be followed up using electronic records in a longitudinal fashion but did not wish to be randomized. The observational and standard groups therefore received the same diabetes care.

Interventions

Structured nurse led intervention programme BEHAVIORAL

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.

Interventional/intensive

Standard care OTHER

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

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus Can provide written informed consent

You may not qualify if:

• Hypoglycaemia from cause not related to diabetes mellitus

Sponsors & Collaborators

• University of Leeds: lead
• Yorkshire Ambulance Service NHS Trust: collaborator
• LifeScan: collaborator

Study Sites (1)

Diabetes centre, St James hospital

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

Related Publications (1)

• Pearson SM, Whittam B, Kulavarasalingam K, Mitchell-Gears A, James C, Ajjan RA. 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. Cardiovasc Diabetol. 2021 Jan 12;20(1):18. doi: 10.1186/s12933-020-01204-3.

  PMID: 33435992 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ramzi Ajjan, PHD

  Professor of metabolic medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention 9a nurse led education programme) it was not possible to mask participant or trial team to the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of metabolic medicine

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 9, 2020
• Study Start: February 1, 2013
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2018
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)