Diabetes Mellitus Clinical Trial
Official title:
Hypoglycemia Requiring Emergency Services Intervention: Patient Characteristics, Outcome and Cardiovascular Risk Profile
NCT number | NCT04422145 |
Other study ID # | P1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2013 |
Est. completion date | December 18, 2018 |
Verified date | June 2020 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 323 |
Est. completion date | December 18, 2018 |
Est. primary completion date | December 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Diabetes mellitus Can provide written informed consent Exclusion Criteria: Hypoglycaemia from cause not related to diabetes mellitus |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Diabetes centre, St James hospital | Leeds | West Yorkshire |
Lead Sponsor | Collaborator |
---|---|
University of Leeds | LifeScan, Yorkshire Ambulance Service NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | All cause mortality at 12 months from recruitment. | Assessment of all-cause mortality at 12 months from recruitment to study. | 12 months | |
Secondary | 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). | |
Secondary | 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.) |
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