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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Hypoglycemia
• Intervention / Treatment: Behavioral: Structured nurse led intervention programme; Other: Standard care

Detailed Description

Previous studies, including our own, have shown that in those with diabetes, severe hypoglycaemia (defined as requiring the assistance of emergency ambulance in the community) carries with it a high mortality in the immediate months/short years following the event. What isn't known is what this group of patients dies of and what the demographics of this group may be. This is important as this is a vulnerable patient group in whom few interventions to reduce this excess mortality have been trialled.

Through a collaboration with a local ambulance service, the hospital diabetes research team set out to recruit participants to a small, pilot, randomized controlled trial to try and ascertain more about the demographics of this group, follow them up in a longitudinal fashion and report on their causes of death using information recorded on death certificates (a statutory requirement in the UK). Additionally the investigators sought to provide pilot data on whether a structured nurse led intervention programme could reduce risk.

The local ambulance service contacted the research team, with patient consent, once they had been called to treat a patient with diabetes whom had severe hypoglycaemia. Within 7 days a research nurse approached those whom had given consent to invite them to take part in a clinical trial. Full eligibility criteria are available elsewhere in this document. Following this, groups were split in the following way:

1. Intensive group - participants were randomized to receive a structured nurse led intervention aiming to educate them on the treatment of and how to avoid hypoglycaemia.
2. Standard group - participants were randomized to continue on their current diabetes treatment and were returned to their standard diabetes care provider.
3. Observational group - participants were happy to have a baseline visit, and for their case to reviewed using electronic records moving forward, but they did not wish to be randomized to an intervention.

All three groups had baseline data collected including:

• Diabetes specific information, including HbA1c, type of diabetes, diabetes therapy, duration of diabetes, presence of complications. Blood tests were taken at baseline for all groups if participants consented to have this done.
• Demographic data - including age, gender, smoking status, BMI
• Information of co-morbidity - Any other illness the participant may suffer from, any medications they take.

Information regarding baseline characteristics was confirmed using electronic patient records.

Those whom were randomized to a nurse led intervention received a structured education programme for 12 months, with the bulk of the work coming in the first 12 weeks.

At 12 months, all participants active engagement in the programme was terminated. Data was collected electronically on new hospital admissions and deaths over this period as well as changes in HbA1c. Participants also had their electronic records screened at study termination and thus data could be provided on outcome at 12 months and study end (in this case 42.6 months.)

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS97TF
      • Diabetes centre, St James hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Diabetes mellitus Can provide written informed consent

Exclusion Criteria:

Hypoglycaemia from cause not related to diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional/intensive; 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; 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.
Placebo Comparator: Standard; Participants returned to their standard diabetes care provider with no intervention.	Other: Standard care; Participants continue on their current diabetes care plan and are looked after by their usual diabetes care provider
No Intervention: Observational; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality at 12 months from recruitment.	Assessment of all-cause mortality at 12 months from recruitment to study.	12 months
Analyse cause of death at study endpoint (12 months following recruitment of last participant).	Using death certificates to compare cause of death between study groups and between type 1 and type 2 diabetes. After cause of death was obtained, participants were grouped into categories as to mortality, eg cardiovascular cause.	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	To analyse mortality at studies endpoint (defined as 12 months following recruitment of last participant)	Study endpoint (12 months following recruitment of last participant.)

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Yorkshire Ambulance Service NHS Trust; LifeScan
• Investigators: Principal Investigator: Ramzi Ajjan, PHD, Professor of metabolic medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Emergencies; Hypoglycemia
• Other Study ID Numbers: p1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to do so is currently in place. Of course once data is submitted if other researchers contact us we would consider providing data for the purpose of meta analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No