<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/NCT04452396</url>
  </required_header>
  <id_info>
    <org_study_id>265405</org_study_id>
    <nct_id>NCT04452396</nct_id>
  </id_info>
  <brief_title>CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia</brief_title>
  <official_title>Continuous Glucose Monitoring: An Evaluation of Impact on Improving the Efficiency of Diagnostic Processes and Enhancing Patient Safety in the Management of Reactive and Spontaneous Hypoglycaemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barts &amp; The London NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Use of CGM to determine diagnosis in possible spontaneous or reactive hypoglycaemia.&#xD;
&#xD;
      Use of CGM to aid treatment optimisation in spontaneous or reactive hypoglycaemia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The human body's blood sugar levels are tightly controlled by the hormone insulin, produced&#xD;
      by the pancreas. If the pancreas produces too much insulin, then the blood sugar will fall to&#xD;
      low levels (hypoglycaemia). Insulin overproduction can happen as a result of the body&#xD;
      misreading a change in blood sugar levels after eating (such as after obesity surgery) or&#xD;
      through tumours of the pancreas which overproduce insulin (insulinomas).&#xD;
&#xD;
      Hypoglycaemia can cause subtle symptoms such as tiredness, poor concentration, or dizziness&#xD;
      and if untreated more severe symptoms including fits, coma and death. Low blood sugars can go&#xD;
      unnoticed at night and if levels fall frequently, people can lose their ability to notice&#xD;
      subtle symptoms.&#xD;
&#xD;
      People suspected of having hypoglycaemia require a series of investigations to try and&#xD;
      reproduce a low blood sugar under controlled conditions. This often requires an admission to&#xD;
      hospital for a few days and multiple finger pricks to test the blood sugar - which patients&#xD;
      often find painful. If low blood sugars caused by too much insulin are confirmed then medical&#xD;
      treatment is started in the first instance, with surgery possibly following later. The only&#xD;
      way to check whether these medications are working is by home fingerprick glucose&#xD;
      measurements. If people have low sugars at night or have lost their ability to notice&#xD;
      symptoms of low blood sugar, it is very difficult to be sure that the medical treatment is&#xD;
      working.&#xD;
&#xD;
      The investigators plan to use continuous glucose monitoring probes to measure patient's blood&#xD;
      sugar prior to and during admission for formal investigation for hypoglycaemia (alongside&#xD;
      conventional fingerprick and blood testing). This might allow us to exclude hypoglycaemia as&#xD;
      a cause of their symptoms, avoiding lengthy admissions.&#xD;
&#xD;
      The investigators will also use this technology (alongside fingerprick testing) to test how&#xD;
      well medical treatment is working in patients with proven hypoglycaemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 18, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>2 phases to study. Patients can enter at start of either phase and start phase 2 at the end of phase 1.&#xD;
Phase 1 - CGM monitoring of people with suspected spontaneous/reactive hypoglycaemia phase 2 - CGM monitoring of patients with medically managed spontaneous/reactive hypoglycaemia</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Phase 1 - (diagnostic) The CGM device will be blinded to the patient and physician until investigations into hypoglycaemia are complete phase 2 - (treatment optimisation) The CGM device will be blinded to the patient and physician for the first 10 days of treatment, medication will be optimised and the patient will continue with CGM in an unblinded way for up to 20 further days to aid further treatment optimisation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>study arm 1 - diagnosing hypoglycaemic episodes using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose</measure>
    <time_frame>up to 5 days prior to admission for hypoglycaemia investigations</time_frame>
    <description>outpatient - CGM findings reflect patient's fingerprick glucose readings&#xD;
Episodes of true hypoglycaemia (glucose measurement &lt;4, &lt;3.0, &lt;2.2mmol/L as decided by finger prick glucose testing) are captured by the CGM device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>study arm 1 - diagnosing hypoglycaemic episodes (glucose measurement &lt;4mmol/L) using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose</measure>
    <time_frame>up to 5 days in hospital during investigations for hypoglycaemia</time_frame>
    <description>inpatient - CGM findings reflect patient's fingerprick glucose readings&#xD;
Episodes of true hypoglycaemia (glucose measurement &lt;4, &lt;3.0, &lt;2.2mmol/L, as decided by finger prick glucose testing) are captured by the CGM device Inpatient - 72 hour fast - CGM device calls hypoglycaemia (glucose measurement &lt;4, &lt;3.0, &lt;2.2mmol/L) when fingerprick/lab glucoses also do</description>
  </primary_outcome>
  <primary_outcome>
    <measure>study arm 2 - using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose to optimise hypoglycaemia treatment in patients with an established diagnosis of spontaneous or reactive hypoglycaemia</measure>
    <time_frame>up to 30 days</time_frame>
    <description>blinded phase - CGM findings reflect patient's fingerprick glucose readings- any episodes of true hypoglycaemia (as decided by fingerprick glucose testing) are captured by CGM device unblinded phase - CGM recordings help with titration of anti hypoglycaemic medications and this reduces overall incidence of hypoglycaemic episodes or duration of time spent in hypoglycaemic range (&lt;4, &lt;3.0, &lt;2.2 mmol/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>assessing concordance between CGMS and lab/finger prick glucose testing</measure>
    <time_frame>up to 10 days (study arm 1) or up to 30 days (study arm 2)</time_frame>
    <description>To determine whether CGM systems accurately record hypoglycaemia and can be used in this context</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hypoglycemia, Reactive</condition>
  <condition>Hypoglycaemia Night</condition>
  <condition>Hypoglycemia Non-Diabetic</condition>
  <condition>Hypoglycemia Unawareness</condition>
  <condition>Insulinoma</condition>
  <condition>Insulinoma; Malignant, Pancreas</condition>
  <condition>Insulin Hypoglycemia</condition>
  <condition>Insulin Resistance</condition>
  <condition>Spontaneous Hypoglycemia</condition>
  <condition>Neuro Endocrine Tumours</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients undergoing CGM monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>use of continuous glucose monitoring</intervention_name>
    <description>Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.</description>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  phase 1 - under investigation for possible/probable hypoglycaemia&#xD;
&#xD;
          -  phase 2 - on medical therapy for established hypoglycaemia&#xD;
&#xD;
          -  Must be Able and willing to give informed consent. No vulnerable adults will be&#xD;
             included.&#xD;
&#xD;
          -  Must be Aged &gt;18 years&#xD;
&#xD;
        Can be;&#xD;
&#xD;
          -  Any ethnicity&#xD;
&#xD;
          -  Any socio economic group&#xD;
&#xD;
          -  Either conventional gender, or non-binary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must not be unwilling or unable to give consent&#xD;
&#xD;
          -  Must not be unable to speak sufficient English to give consent and understand study&#xD;
             requirements&#xD;
&#xD;
          -  Must not be Aged&lt;18 or &gt;90 years&#xD;
&#xD;
          -  Must not be lack capacity to consent&#xD;
&#xD;
          -  Must not have an underlying hepatic condition&#xD;
&#xD;
          -  Must not have a current excessive alcohol consumption (men regularly consuming &gt;50&#xD;
             units/week, women &gt;35 units/week)&#xD;
&#xD;
          -  Must not have Diabetes Mellitus&#xD;
&#xD;
          -  Must not be currently using Diabetic medication or insulin&#xD;
&#xD;
          -  Must not be currently pregnant&#xD;
&#xD;
          -  Must not be on haemo or peritoneal dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Scott Akker, MBBS</last_name>
    <phone>0207 377 7000</phone>
    <email>bhnt.endocrine@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Craig Stiles, MBBS</last_name>
    <phone>0207 377 7000</phone>
    <phone_ext>57133</phone_ext>
    <email>bhnt.endocrine@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St Bartholomew's Hospital, dept of endocrinology</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott Akker, MBBS</last_name>
      <phone>02073777000</phone>
      <email>bhnt.endocrine@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Craig Stiles, MBBS</last_name>
      <phone>02073777000</phone>
      <phone_ext>57133</phone_ext>
      <email>bhnt.endocrine@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 18, 2019</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypoglycaemia</keyword>
  <keyword>insulinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulinoma</mesh_term>
    <mesh_term>Endocrine Gland Neoplasms</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04452396/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04452396/ICF_001.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/NCT04452396
org study id: 265405
nct id: NCT04452396
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Use of CGM to determine diagnosis in possible spontaneous or reactive hypoglycaemia.

      Use of CGM to aid treatment optimisation in spontaneous or reactive hypoglycaemia
The human body's blood sugar levels are tightly controlled by the hormone insulin, produced
      by the pancreas. If the pancreas produces too much insulin, then the blood sugar will fall to
      low levels (hypoglycaemia). Insulin overproduction can happen as a result of the body
      misreading a change in blood sugar levels after eating (such as after obesity surgery) or
      through tumours of the pancreas which overproduce insulin (insulinomas).

      Hypoglycaemia can cause subtle symptoms such as tiredness, poor concentration, or dizziness
      and if untreated more severe symptoms including fits, coma and death. Low blood sugars can go
      unnoticed at night and if levels fall frequently, people can lose their ability to notice
      subtle symptoms.

      People suspected of having hypoglycaemia require a series of investigations to try and
      reproduce a low blood sugar under controlled conditions. This often requires an admission to
      hospital for a few days and multiple finger pricks to test the blood sugar - which patients
      often find painful. If low blood sugars caused by too much insulin are confirmed then medical
      treatment is started in the first instance, with surgery possibly following later. The only
      way to check whether these medications are working is by home fingerprick glucose
      measurements. If people have low sugars at night or have lost their ability to notice
      symptoms of low blood sugar, it is very difficult to be sure that the medical treatment is
      working.

      The investigators plan to use continuous glucose monitoring probes to measure patient's blood
      sugar prior to and during admission for formal investigation for hypoglycaemia (alongside
      conventional fingerprick and blood testing). This might allow us to exclude hypoglycaemia as
      a cause of their symptoms, avoiding lengthy admissions.

      The investigators will also use this technology (alongside fingerprick testing) to test how
      well medical treatment is working in patients with proven hypoglycaemia.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 2 phases to study. Patients can enter at start of either phase and start phase 2 at the end of phase 1.
Phase 1 - CGM monitoring of people with suspected spontaneous/reactive hypoglycaemia phase 2 - CGM monitoring of patients with medically managed spontaneous/reactive hypoglycaemia
primary purpose: Diagnostic
masking: None (Open Label)
masking description: Phase 1 - (diagnostic) The CGM device will be blinded to the patient and physician until investigations into hypoglycaemia are complete phase 2 - (treatment optimisation) The CGM device will be blinded to the patient and physician for the first 10 days of treatment, medication will be optimised and the patient will continue with CGM in an unblinded way for up to 20 further days to aid further treatment optimisation
measure: study arm 1 - diagnosing hypoglycaemic episodes using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose
time frame: up to 5 days prior to admission for hypoglycaemia investigations
description: outpatient - CGM findings reflect patient's fingerprick glucose readings
Episodes of true hypoglycaemia (glucose measurement <4, <3.0, <2.2mmol/L as decided by finger prick glucose testing) are captured by the CGM device
measure: study arm 1 - diagnosing hypoglycaemic episodes (glucose measurement <4mmol/L) using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose
time frame: up to 5 days in hospital during investigations for hypoglycaemia
description: inpatient - CGM findings reflect patient's fingerprick glucose readings
Episodes of true hypoglycaemia (glucose measurement <4, <3.0, <2.2mmol/L, as decided by finger prick glucose testing) are captured by the CGM device Inpatient - 72 hour fast - CGM device calls hypoglycaemia (glucose measurement <4, <3.0, <2.2mmol/L) when fingerprick/lab glucoses also do
measure: study arm 2 - using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose to optimise hypoglycaemia treatment in patients with an established diagnosis of spontaneous or reactive hypoglycaemia
time frame: up to 30 days
description: blinded phase - CGM findings reflect patient's fingerprick glucose readings- any episodes of true hypoglycaemia (as decided by fingerprick glucose testing) are captured by CGM device unblinded phase - CGM recordings help with titration of anti hypoglycaemic medications and this reduces overall incidence of hypoglycaemic episodes or duration of time spent in hypoglycaemic range (<4, <3.0, <2.2 mmol/L)
measure: assessing concordance between CGMS and lab/finger prick glucose testing
time frame: up to 10 days (study arm 1) or up to 30 days (study arm 2)
description: To determine whether CGM systems accurately record hypoglycaemia and can be used in this context
arm group label: patients
arm group type: Experimental
description: patients undergoing CGM monitoring
intervention type: Device
intervention name: use of continuous glucose monitoring
description: Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.
arm group label: patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Scott Akker, MBBS
phone: 0207 377 7000
email: bhnt.endocrine@nhs.net
last name: Craig Stiles, MBBS
phone: 0207 377 7000
phone ext: 57133
email: bhnt.endocrine@nhs.net
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Insulinoma
mesh term: Endocrine Gland Neoplasms
mesh term: Neuroendocrine Tumors
mesh term: Insulin Resistance
mesh term: Hypoglycemia
provided document: 
provided document: 