<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422145</url>
  </required_header>
  <id_info>
    <org_study_id>P1</org_study_id>
    <nct_id>NCT04422145</nct_id>
  </id_info>
  <brief_title>Hypoglycemia Requiring Emergency Services Intervention: Patient Characteristics, Outcome and Cardiovascular Risk Profile</brief_title>
  <official_title>Hypoglycemia Requiring Emergency Services Intervention: Patient Characteristics, Outcome and Cardiovascular Risk Profile</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yorkshire Ambulance Service NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LifeScan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who suffer hypoglycaemia in the community requiring the services of an ambulance are&#xD;
      known to have a high short term mortality based on previous work. What is not known is the&#xD;
      demographics of this group and also what the cause of death was for individuals whom&#xD;
      unfortunately passed away in the time following ambulance callout. Importantly, studies&#xD;
      looking at interventions to reduce poor outcomes in this group are lacking. The investigators&#xD;
      conducted a pilot trial with the main goals to:&#xD;
&#xD;
        1. Characterise this group in more detail and ascertain what was recorded as cause of death&#xD;
           in those whom passed away in the months/years following community hypoglycaemia&#xD;
&#xD;
        2. Ascertain if a simple nurse led intervention, focusing on educating participants on&#xD;
           avoidance of hypoglycaemia, could improve outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies, including our own, have shown that in those with diabetes, severe&#xD;
      hypoglycaemia (defined as requiring the assistance of emergency ambulance in the community)&#xD;
      carries with it a high mortality in the immediate months/short years following the event.&#xD;
      What isn't known is what this group of patients dies of and what the demographics of this&#xD;
      group may be. This is important as this is a vulnerable patient group in whom few&#xD;
      interventions to reduce this excess mortality have been trialled.&#xD;
&#xD;
      Through a collaboration with a local ambulance service, the hospital diabetes research team&#xD;
      set out to recruit participants to a small, pilot, randomized controlled trial to try and&#xD;
      ascertain more about the demographics of this group, follow them up in a longitudinal fashion&#xD;
      and report on their causes of death using information recorded on death certificates (a&#xD;
      statutory requirement in the UK). Additionally the investigators sought to provide pilot data&#xD;
      on whether a structured nurse led intervention programme could reduce risk.&#xD;
&#xD;
      The local ambulance service contacted the research team, with patient consent, once they had&#xD;
      been called to treat a patient with diabetes whom had severe hypoglycaemia. Within 7 days a&#xD;
      research nurse approached those whom had given consent to invite them to take part in a&#xD;
      clinical trial. Full eligibility criteria are available elsewhere in this document. Following&#xD;
      this, groups were split in the following way:&#xD;
&#xD;
        1. Intensive group - participants were randomized to receive a structured nurse led&#xD;
           intervention aiming to educate them on the treatment of and how to avoid hypoglycaemia.&#xD;
&#xD;
        2. Standard group - participants were randomized to continue on their current diabetes&#xD;
           treatment and were returned to their standard diabetes care provider.&#xD;
&#xD;
        3. Observational group - participants were happy to have a baseline visit, and for their&#xD;
           case to reviewed using electronic records moving forward, but they did not wish to be&#xD;
           randomized to an intervention.&#xD;
&#xD;
      All three groups had baseline data collected including:&#xD;
&#xD;
        -  Diabetes specific information, including HbA1c, type of diabetes, diabetes therapy,&#xD;
           duration of diabetes, presence of complications. Blood tests were taken at baseline for&#xD;
           all groups if participants consented to have this done.&#xD;
&#xD;
        -  Demographic data - including age, gender, smoking status, BMI&#xD;
&#xD;
        -  Information of co-morbidity - Any other illness the participant may suffer from, any&#xD;
           medications they take.&#xD;
&#xD;
      Information regarding baseline characteristics was confirmed using electronic patient&#xD;
      records.&#xD;
&#xD;
      Those whom were randomized to a nurse led intervention received a structured education&#xD;
      programme for 12 months, with the bulk of the work coming in the first 12 weeks.&#xD;
&#xD;
      At 12 months, all participants active engagement in the programme was terminated. Data was&#xD;
      collected electronically on new hospital admissions and deaths over this period as well as&#xD;
      changes in HbA1c. Participants also had their electronic records screened at study&#xD;
      termination and thus data could be provided on outcome at 12 months and study end (in this&#xD;
      case 42.6 months.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2013</start_date>
  <completion_date type="Actual">December 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 18, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>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</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>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.)</measure>
    <time_frame>Through study endpoint, which was 58 months following the recruitment of the first participant and 12 months following the recruitment of the last participant.</time_frame>
    <description>Electronic review of participants records to ascertain if they had passed away during the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality at 12 months from recruitment.</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of all-cause mortality at 12 months from recruitment to study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyse cause of death at study endpoint (12 months following recruitment of last participant).</measure>
    <time_frame>Study end point defined as 12 months following recruitment of last participant (approximately 40 months from start of study).</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of differences in mortality rate between type 1 and type 2 diabetes participants</measure>
    <time_frame>Study endpoint (12 months following recruitment of last participant.)</time_frame>
    <description>To analyse mortality at studies endpoint (defined as 12 months following recruitment of last participant)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">323</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Interventional/intensive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants returned to their standard diabetes care provider with no intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured nurse led intervention programme</intervention_name>
    <description>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.</description>
    <arm_group_label>Interventional/intensive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Participants continue on their current diabetes care plan and are looked after by their usual diabetes care provider</description>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diabetes mellitus Can provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Hypoglycaemia from cause not related to diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramzi Ajjan, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of metabolic medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes centre, St James hospital</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS97TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Ramzi Ajjan</investigator_full_name>
    <investigator_title>Professor of metabolic medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 10, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04422145/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422145
org study id: P1
nct id: NCT04422145
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: 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
measure: 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.)
time frame: Through study endpoint, which was 58 months following the recruitment of the first participant and 12 months following the recruitment of the last participant.
description: Electronic review of participants records to ascertain if they had passed away during the study
measure: All cause mortality at 12 months from recruitment.
time frame: 12 months
description: Assessment of all-cause mortality at 12 months from recruitment to study.
measure: Analyse cause of death at study endpoint (12 months following recruitment of last participant).
time frame: Study end point defined as 12 months following recruitment of last participant (approximately 40 months from start of study).
description: 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.
measure: Assessment of differences in mortality rate between type 1 and type 2 diabetes participants
time frame: Study endpoint (12 months following recruitment of last participant.)
description: To analyse mortality at studies endpoint (defined as 12 months following recruitment of last participant)
arm group label: Interventional/intensive
arm group type: Active Comparator
description: 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.
arm group label: Standard
arm group type: Placebo Comparator
description: Participants returned to their standard diabetes care provider with no intervention.
arm group label: Observational
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Structured nurse led intervention programme
description: 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.
arm group label: Interventional/intensive
intervention type: Other
intervention name: Standard care
description: Participants continue on their current diabetes care plan and are looked after by their usual diabetes care provider
arm group label: Standard
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ramzi Ajjan, PHD
role: Principal Investigator
affiliation: Professor of metabolic medicine
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Ramzi Ajjan
investigator title: Professor of metabolic medicine
mesh term: Hypoglycemia
mesh term: Emergencies
sharing ipd: No
ipd 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
provided document: 