xml: <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/NCT06038669</url>
    </required_header>
    <id_info>
      <org_study_id>3242</org_study_id>
      <nct_id>NCT06038669</nct_id>
    </id_info>
    <brief_title>User Evaluation of a Home-collection Kit for People With Diabetes</brief_title>
    <official_title>User Evaluation of a Home-collection Kit for People With Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospitals of North Midlands NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospitals of North Midlands NHS Trust</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>
        Type 1 and Type 2 are the most common types of diabetes mellitus. Although the cause of Type&#xD;
        1 is different to Type 2, they can both lead to high blood glucose levels as the patient is&#xD;
        unable to store and use sugar. The disease is an epidemic of the 21st century which is&#xD;
        increasing, having a current prevalence of approximately 8%.&#xD;
  &#xD;
        Poor disease control is associated with a range of long-term health conditions which have a&#xD;
        severe impact upon quality of life and are responsible for the increased morbidity and&#xD;
        mortality associated with the disease.&#xD;
  &#xD;
        Healthcare professionals use HbA1c as the main marker to monitor diabetic control. Patients&#xD;
        with diabetes have regular review appointments to monitor their overall health and discuss&#xD;
        their HbA1c target and results. The purpose of monitoring patients with diabetes is to&#xD;
        improve patient outcomes. It is known that poor control is associated with poor clinical&#xD;
        outcomes and also that reduced monitoring is linked to suboptimal diabetic control.&#xD;
        Therefore, aiming for the correct monitoring frequency helps towards achieving the best&#xD;
        control which can lead to the most favourable clinical outcomes. The inconvenience of&#xD;
        attending for a blood test and follow-up appointment is a major factor affecting patient&#xD;
        adherence to monitoring, locally approximately 50% of patients with diabetes have their HbA1c&#xD;
        level measured either too soon or too late.&#xD;
  &#xD;
        To address this issue and improve access to monitoring at the correct time interval we aim to&#xD;
        produce a HbA1c home testing kit which can be posted back to the laboratory at the&#xD;
        convenience of the patient. The kit will be developed based on feedback from patients with&#xD;
        diabetes and will use a dried blood spot sample to produce HbA1c results comparable to the&#xD;
        whole blood standard method.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>DBS kit outcome</measure>
      <time_frame>1 year, 3 months</time_frame>
      <description>For the DBS-based home collection kit used by patients to be 'fit for purpose', it must achieve the following:&#xD;
  Assay performance - correlation and bias. Correlation coefficient (r2 value) from linear regression plot should be &gt;0.95 with a bias of less than 5%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participant questionnaires</measure>
      <time_frame>1 year, 3 months</time_frame>
      <description>Completed participant questionnaires will be collated and analysed for themes. We aim to determine whether participants deem the home-collection kit to be acceptable. The information gained will be used to design a full study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interviews</measure>
      <time_frame>1 year, 3 months</time_frame>
      <description>The health care professional interview transcripts will be recorded and analysed. The emerging themes will be taken into consideration when designing the full study.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Diabetes</condition>
    <arm_group>
      <arm_group_label>People with diabetes</arm_group_label>
      <description>Patients who have diabetes will be asked to use a home collection kit to collect a dried blood spot sample which will be compared to the HbA1C result.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Health care professionals</arm_group_label>
      <description>Health care professionals who work with diabetic patients will be interviewed and asked about diabetes monitoring in the healthcare setting, comments on current laboratory service, patient engagement, comments on service improvement</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dried blood spot device</intervention_name>
      <description>Patients will be asked to provide a dried blood spot sample</description>
      <arm_group_label>People with diabetes</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Healthcare professional interviews</intervention_name>
      <description>Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring</description>
      <arm_group_label>Health care professionals</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Diabetic patients (type I and II) aged over 18 years old.&#xD;
  &#xD;
          Healthcare professionals aged 18 or over who work with patients with diabetes.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of Type I or Type II diabetes&#xD;
  &#xD;
            -  Aged 18 years or over&#xD;
  &#xD;
            -  Venous blood sample for HbA1c collected within the two weeks prior to the clinic&#xD;
               appointment&#xD;
  &#xD;
            -  Ability to provide fully informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English speaking where translation of the study documents and procedures could&#xD;
               limit fully informed consent&#xD;
  &#xD;
            -  Severe visual impairment which would leave the participant unable to complete the&#xD;
               study procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University Hospitals of North Midlands NHS Trust</name>
        <address>
          <city>Stoke-on-Trent</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Megan Young</last_name>
        <phone>01782 675384</phone>
        <email>megan.young@uhnm.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Kate Ford</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038669
  org study id: 3242
  nct id: NCT06038669
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Type 1 and Type 2 are the most common types of diabetes mellitus. Although the cause of Type
        1 is different to Type 2, they can both lead to high blood glucose levels as the patient is
        unable to store and use sugar. The disease is an epidemic of the 21st century which is
        increasing, having a current prevalence of approximately 8%.
  
        Poor disease control is associated with a range of long-term health conditions which have a
        severe impact upon quality of life and are responsible for the increased morbidity and
        mortality associated with the disease.
  
        Healthcare professionals use HbA1c as the main marker to monitor diabetic control. Patients
        with diabetes have regular review appointments to monitor their overall health and discuss
        their HbA1c target and results. The purpose of monitoring patients with diabetes is to
        improve patient outcomes. It is known that poor control is associated with poor clinical
        outcomes and also that reduced monitoring is linked to suboptimal diabetic control.
        Therefore, aiming for the correct monitoring frequency helps towards achieving the best
        control which can lead to the most favourable clinical outcomes. The inconvenience of
        attending for a blood test and follow-up appointment is a major factor affecting patient
        adherence to monitoring, locally approximately 50% of patients with diabetes have their HbA1c
        level measured either too soon or too late.
  
        To address this issue and improve access to monitoring at the correct time interval we aim to
        produce a HbA1c home testing kit which can be posted back to the laboratory at the
        convenience of the patient. The kit will be developed based on feedback from patients with
        diabetes and will use a dried blood spot sample to produce HbA1c results comparable to the
        whole blood standard method.
  observational model: Cohort
  time perspective: Prospective
  measure: DBS kit outcome
  time frame: 1 year, 3 months
  description: For the DBS-based home collection kit used by patients to be 'fit for purpose', it must achieve the following:
  Assay performance - correlation and bias. Correlation coefficient (r2 value) from linear regression plot should be >0.95 with a bias of less than 5%.
  measure: Participant questionnaires
  time frame: 1 year, 3 months
  description: Completed participant questionnaires will be collated and analysed for themes. We aim to determine whether participants deem the home-collection kit to be acceptable. The information gained will be used to design a full study.
  measure: Interviews
  time frame: 1 year, 3 months
  description: The health care professional interview transcripts will be recorded and analysed. The emerging themes will be taken into consideration when designing the full study.
  arm group label: People with diabetes
  description: Patients who have diabetes will be asked to use a home collection kit to collect a dried blood spot sample which will be compared to the HbA1C result.
  arm group label: Health care professionals
  description: Health care professionals who work with diabetic patients will be interviewed and asked about diabetes monitoring in the healthcare setting, comments on current laboratory service, patient engagement, comments on service improvement
  intervention type: Device
  intervention name: Dried blood spot device
  description: Patients will be asked to provide a dried blood spot sample
  arm group label: People with diabetes
  intervention type: Other
  intervention name: Healthcare professional interviews
  description: Health care professionals only will be interviewed using the topic guide and asked about their experience of diabetes monitoring
  arm group label: Health care professionals
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  sharing ipd: No