<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/NCT03748433</url>
  </required_header>
  <id_info>
    <org_study_id>18HH4609</org_study_id>
    <nct_id>NCT03748433</nct_id>
  </id_info>
  <brief_title>Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia</brief_title>
  <acronym>AIR-CGM</acronym>
  <official_title>Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>London Ambulance Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the impact of real-time continuous glucose monitoring on the&#xD;
      frequency, duration, awareness and severity of hypoglycaemia in people with type 1 diabetes&#xD;
      and a recent history of severe hypoglycaemia, compared to usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 diabetes (T1DM), which affects 300,000 in the UK, is characterised by autoimmune&#xD;
      destruction of the pancreatic beta cells, leading to absolute deficiency of insulin.&#xD;
      Management of T1DM requires exogenous insulin administration, aiming for glucose&#xD;
      concentrations as close to physiological values as possible. Intensive management of T1DM&#xD;
      improves glucose control and reduces the risk of microvascular diabetes complications and&#xD;
      cardiovascular disease1. In the UK diabetes consumes more than 10% of the National Health&#xD;
      Service budget 2 and in the USA a relatively greater amount is spent on type 1 compared with&#xD;
      type 2 diabetes (8.6% of the diabetes budget compared with 5.6% of diabetes prevalence)3.&#xD;
      Medication and insulin pump therapy accounts for less than 10% of diabetes expenditure with&#xD;
      the majority of costs incurred in the treatment of complications4.&#xD;
&#xD;
      Optimal control remains challenging to achieve and intensive insulin treatment increases the&#xD;
      risk of severe hypoglycaemia, with lower glucose values also associated with an increased&#xD;
      frequency and severity of moderate hypoglycaemia5, 6. Severe hypoglycaemia is defined as any&#xD;
      episode of hypoglycaemia requiring the assistance of a third party actively to treat.&#xD;
      Hypoglycaemia is associated with morbidity and even mortality, and places a financial burden&#xD;
      on health systems.&#xD;
&#xD;
      Severe hypoglycaemia costs £13million per year in NHS costs7. Between 4 and 10% of deaths in&#xD;
      people with type 1 diabetes are attributed to hypoglycaemia and the risk of severe&#xD;
      hypoglycaemia increases 6-fold in people with impaired awareness of hypoglycaemia. Avoidance&#xD;
      of hypoglycaemia is associated with restoration of hypoglycaemia awareness and this may be&#xD;
      enabled by the use of continuous glucose monitoring.&#xD;
&#xD;
      In type 1 diabetes real-time continuous glucose monitoring (CGM) improves overall glucose&#xD;
      control in all age groups when used continuously, reduces hypoglycaemia in people with an&#xD;
      HbA1c &lt;7.0%, and may reduce severe hypoglycaemia8-10.&#xD;
&#xD;
      The predictive Low-Glucose suspend (PLGS) feature in sensor augmented insulin pumps (SAP)&#xD;
      automatically reduces insulin delivery when trends in CGM glucose concentrations predict&#xD;
      future hypoglycaemia, and significantly reduces hypoglycaemia without rebound hyperglycaemia&#xD;
      compared to SAP without PLGS11.&#xD;
&#xD;
      In England continuous glucose monitoring is supported by NICE for people with type 1 diabetes&#xD;
      who are willing to commit to using it at least 70% of the time and to calibrate it as needed,&#xD;
      and who have any of the following despite optimised use of insulin therapy and conventional&#xD;
      blood glucose monitoring12:&#xD;
&#xD;
        -  More than 1 episode a year of severe hypoglycaemia with no obvious preventable&#xD;
           precipitating cause.&#xD;
&#xD;
        -  Complete loss of awareness of hypoglycaemia.&#xD;
&#xD;
        -  Frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing&#xD;
           problems with daily activities.&#xD;
&#xD;
        -  Extreme fear of hypoglycaemia.&#xD;
&#xD;
        -  Hyperglycaemia (HbA1c level of 75 mmol/mol [9%] or higher) that persists despite testing&#xD;
           at least 10 times a day&#xD;
&#xD;
      Addressing severe hypoglycaemia, reducing the risk of further episodes and acting promptly to&#xD;
      optimise hypoglycaemia awareness are critical in people at high risk.&#xD;
&#xD;
      Continuous subcutaneous insulin pump therapy is supported for adults and children over 12&#xD;
      with type 1 diabetes in whom attempts to achieve target haemoglobin A1c (HbA1c) with multiple&#xD;
      daily injections (MDI) have resulted in disabling hypoglycaemia or HbA1c levels have remained&#xD;
      high (8.5% [69 mmol/mol] or above) despite high level care12.&#xD;
&#xD;
      This study consists of 3 phases: The main study (SMBG vs RT-CGM for 12 weeks), an optional&#xD;
      Extended Phase 1 (RT-CGM for 6 months) and a further optional Extended phase 2 (where&#xD;
      participants have the choice to continue on RT-CGM or to be re-randomised onto RT-CGM alone&#xD;
      or RT-CGM with CSII).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">September 9, 2021</completion_date>
  <primary_completion_date type="Actual">September 9, 2021</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>
    <intervention_model_description>Randomised open-label parallel group study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time spent in hypoglycaemia</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage time spent in hypoglycaemia (&lt;3.0mmol/L, 55mg/dL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time spent in hypoglycaemia (&lt;3.9mmol/L, 70mg/dL)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage time spent in hypoglycaemia (&lt;3.9mmol/L, 70mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of episode of serious hypoglycaemia</measure>
    <time_frame>12 weeks</time_frame>
    <description>defined as a sensor glucose &lt;3.0mmol/L (55mg/dL) for &gt;20 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time in euglycaemia</measure>
    <time_frame>12 weeks</time_frame>
    <description>% time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time spent in target</measure>
    <time_frame>12 weeks</time_frame>
    <description>% time spent in target (3.9-10mmol/L, 70-180mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time spent in hyperglycaemia</measure>
    <time_frame>12 weeks</time_frame>
    <description>% time spent in hyperglycaemia (&gt;10mmol/L, 180mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hypoglycaemic excursions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number hypoglycaemic excursions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Hypoglycaemia</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured via CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Absolute Difference in Glucose (MAD%)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured via CGM expressed as a percentage reference value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Variability</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured via CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured via venous blood tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulance call-out rates</measure>
    <time_frame>12 weeks</time_frame>
    <description>Provided by LAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DTSQ</measure>
    <time_frame>12 weeks</time_frame>
    <description>Diabetes Treatment Satisfaction Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Usability</measure>
    <time_frame>12 weeks</time_frame>
    <description>Continuous Glucose Monitoring Usability Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAID</measure>
    <time_frame>12 weeks</time_frame>
    <description>Problem Area in Diabetes Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gold Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hypoglycaemia awareness (GOLD score) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HFS2 questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fear of Hypoglycaemia Survey Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness (measured in pounds sterling)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cost effectiveness of CGM when compared with SMBG</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Hypoglycemia Unawareness</condition>
  <condition>Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Continuous Glucose Monitoring (CGM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self Monitoring Blood Glucose (SMBG)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous Subcutaneous Insulin Infusion (CSII)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be re-consented with the choice to continue using RT-CGM for a further 16 weeks or be re-randomised to either receive the Tandem t:slim X2 insulin pump or RT-CGM. Participants randomised to the Tandem t:slim X2 group will be proficiently trained to safely use the Tandem t:slim X2 insulin pump. All participants (Tandem t:slim X2 and RT-CGM) will be provided with Dexcom G6 real time CGM transmitters and sensors for the 16-week second extension phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom G6 CGM</intervention_name>
    <description>Commercially available Dexcom G6 Continuous Glucose Monitoring</description>
    <arm_group_label>Continuous Glucose Monitoring (CGM)</arm_group_label>
    <arm_group_label>Continuous Subcutaneous Insulin Infusion (CSII)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tandem t:slim X2 Insulin Pump</intervention_name>
    <description>sensor augmented insulin pump with predictive low glucose suspend</description>
    <arm_group_label>Continuous Subcutaneous Insulin Infusion (CSII)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PRE-REGISTRATION EVALUATIONS&#xD;
&#xD;
          -  Episode of severe hypoglycaemia&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes&#xD;
&#xD;
        INCLUSION CRITERIA&#xD;
&#xD;
          -  Adults over 18 years of age&#xD;
&#xD;
          -  Severe hypoglycaemia requiring ambulance call-out or emergency department attendance&#xD;
             within 2 weeks&#xD;
&#xD;
          -  Type 1 diabetes confirmed on the basis of clinical features&#xD;
&#xD;
          -  Type 1 diabetes for greater than 3 years&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Use of CGM within the last 6 months (except short periods of diagnostic blinded use&#xD;
             under clinic supervision). Prior use of Abbott FreeStyle Libre Device is permitted.&#xD;
&#xD;
          -  Use of pre-mixed insulin&#xD;
&#xD;
          -  No access to smartphone or computer&#xD;
&#xD;
          -  Pregnant or planning pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Have active malignancy or under investigation for malignancy&#xD;
&#xD;
          -  Severe visual impairment&#xD;
&#xD;
          -  Reduced manual dexterity&#xD;
&#xD;
          -  Unable to participate due to other factors, as assessed by the Chief Investigators&#xD;
&#xD;
        WITHDRAWAL CRITERIA&#xD;
&#xD;
        Participants will be withdrawn if their ability to give informed consent is impaired.&#xD;
        Participants will also be withdrawn, at the chief investigators discretion, if glucose&#xD;
        control is negatively impacted by the use of either intervention.&#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>Nick Oliver</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imperial College Clinical Research Facility</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.nice.org.uk/guidance/ng17/resources/type-1-diabetes-in-adults-diagnosis-and-management-pdf-1837276469701</url>
    <description>NICE Guidelines</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 20, 2018</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Real time continuous glucose monitoring</keyword>
  <keyword>continuous subcutaneous insulin infusion</keyword>
  <keyword>self monitoring blood glucose</keyword>
  <keyword>sensor augmented pump</keyword>
  <keyword>severe hypoglycaemia</keyword>
  <keyword>hypounaware</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 10, 2022</submitted>
    <returned>August 25, 2023</returned>
    <submitted>September 14, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03748433
org study id: 18HH4609
nct id: NCT03748433
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to assess the impact of real-time continuous glucose monitoring on the
      frequency, duration, awareness and severity of hypoglycaemia in people with type 1 diabetes
      and a recent history of severe hypoglycaemia, compared to usual care.
Type 1 diabetes (T1DM), which affects 300,000 in the UK, is characterised by autoimmune
      destruction of the pancreatic beta cells, leading to absolute deficiency of insulin.
      Management of T1DM requires exogenous insulin administration, aiming for glucose
      concentrations as close to physiological values as possible. Intensive management of T1DM
      improves glucose control and reduces the risk of microvascular diabetes complications and
      cardiovascular disease1. In the UK diabetes consumes more than 10% of the National Health
      Service budget 2 and in the USA a relatively greater amount is spent on type 1 compared with
      type 2 diabetes (8.6% of the diabetes budget compared with 5.6% of diabetes prevalence)3.
      Medication and insulin pump therapy accounts for less than 10% of diabetes expenditure with
      the majority of costs incurred in the treatment of complications4.

      Optimal control remains challenging to achieve and intensive insulin treatment increases the
      risk of severe hypoglycaemia, with lower glucose values also associated with an increased
      frequency and severity of moderate hypoglycaemia5, 6. Severe hypoglycaemia is defined as any
      episode of hypoglycaemia requiring the assistance of a third party actively to treat.
      Hypoglycaemia is associated with morbidity and even mortality, and places a financial burden
      on health systems.

      Severe hypoglycaemia costs £13million per year in NHS costs7. Between 4 and 10% of deaths in
      people with type 1 diabetes are attributed to hypoglycaemia and the risk of severe
      hypoglycaemia increases 6-fold in people with impaired awareness of hypoglycaemia. Avoidance
      of hypoglycaemia is associated with restoration of hypoglycaemia awareness and this may be
      enabled by the use of continuous glucose monitoring.

      In type 1 diabetes real-time continuous glucose monitoring (CGM) improves overall glucose
      control in all age groups when used continuously, reduces hypoglycaemia in people with an
      HbA1c <7.0%, and may reduce severe hypoglycaemia8-10.

      The predictive Low-Glucose suspend (PLGS) feature in sensor augmented insulin pumps (SAP)
      automatically reduces insulin delivery when trends in CGM glucose concentrations predict
      future hypoglycaemia, and significantly reduces hypoglycaemia without rebound hyperglycaemia
      compared to SAP without PLGS11.

      In England continuous glucose monitoring is supported by NICE for people with type 1 diabetes
      who are willing to commit to using it at least 70% of the time and to calibrate it as needed,
      and who have any of the following despite optimised use of insulin therapy and conventional
      blood glucose monitoring12:

        -  More than 1 episode a year of severe hypoglycaemia with no obvious preventable
           precipitating cause.

        -  Complete loss of awareness of hypoglycaemia.

        -  Frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing
           problems with daily activities.

        -  Extreme fear of hypoglycaemia.

        -  Hyperglycaemia (HbA1c level of 75 mmol/mol [9%] or higher) that persists despite testing
           at least 10 times a day

      Addressing severe hypoglycaemia, reducing the risk of further episodes and acting promptly to
      optimise hypoglycaemia awareness are critical in people at high risk.

      Continuous subcutaneous insulin pump therapy is supported for adults and children over 12
      with type 1 diabetes in whom attempts to achieve target haemoglobin A1c (HbA1c) with multiple
      daily injections (MDI) have resulted in disabling hypoglycaemia or HbA1c levels have remained
      high (8.5% [69 mmol/mol] or above) despite high level care12.

      This study consists of 3 phases: The main study (SMBG vs RT-CGM for 12 weeks), an optional
      Extended Phase 1 (RT-CGM for 6 months) and a further optional Extended phase 2 (where
      participants have the choice to continue on RT-CGM or to be re-randomised onto RT-CGM alone
      or RT-CGM with CSII).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised open-label parallel group study
primary purpose: Treatment
masking: None (Open Label)
measure: Time spent in hypoglycaemia
time frame: 12 weeks
description: Percentage time spent in hypoglycaemia (<3.0mmol/L, 55mg/dL)
measure: Time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)
time frame: 12 weeks
description: Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)
measure: Number of episode of serious hypoglycaemia
time frame: 12 weeks
description: defined as a sensor glucose <3.0mmol/L (55mg/dL) for >20 minutes
measure: time in euglycaemia
time frame: 12 weeks
description: % time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
measure: time spent in target
time frame: 12 weeks
description: % time spent in target (3.9-10mmol/L, 70-180mg/dL)
measure: time spent in hyperglycaemia
time frame: 12 weeks
description: % time spent in hyperglycaemia (>10mmol/L, 180mg/dL)
measure: hypoglycaemic excursions
time frame: 12 weeks
description: Number hypoglycaemic excursions
measure: Severe Hypoglycaemia
time frame: 12 weeks
description: Measured via CGM
measure: Mean Absolute Difference in Glucose (MAD%)
time frame: 12 weeks
description: Measured via CGM expressed as a percentage reference value
measure: Glucose Variability
time frame: 12 weeks
description: Measured via CGM
measure: HbA1C
time frame: 12 weeks
description: Measured via venous blood tests
measure: Ambulance call-out rates
time frame: 12 weeks
description: Provided by LAS
measure: DTSQ
time frame: 12 weeks
description: Diabetes Treatment Satisfaction Questionnaire
measure: CGM Usability
time frame: 12 weeks
description: Continuous Glucose Monitoring Usability Questionnaire
measure: PAID
time frame: 12 weeks
description: Problem Area in Diabetes Questionnaire
measure: Gold Score
time frame: 12 weeks
description: Hypoglycaemia awareness (GOLD score) questionnaire
measure: HFS2 questionnaire
time frame: 12 weeks
description: Fear of Hypoglycaemia Survey Score
measure: Cost effectiveness (measured in pounds sterling)
time frame: 12 weeks
description: Cost effectiveness of CGM when compared with SMBG
arm group label: Continuous Glucose Monitoring (CGM)
arm group type: Experimental
description: The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management.
arm group label: Self Monitoring Blood Glucose (SMBG)
arm group type: No Intervention
description: The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.
arm group label: Continuous Subcutaneous Insulin Infusion (CSII)
arm group type: Experimental
description: All participants will be re-consented with the choice to continue using RT-CGM for a further 16 weeks or be re-randomised to either receive the Tandem t:slim X2 insulin pump or RT-CGM. Participants randomised to the Tandem t:slim X2 group will be proficiently trained to safely use the Tandem t:slim X2 insulin pump. All participants (Tandem t:slim X2 and RT-CGM) will be provided with Dexcom G6 real time CGM transmitters and sensors for the 16-week second extension phase.
intervention type: Device
intervention name: Dexcom G6 CGM
description: Commercially available Dexcom G6 Continuous Glucose Monitoring
arm group label: Continuous Glucose Monitoring (CGM)
arm group label: Continuous Subcutaneous Insulin Infusion (CSII)
intervention type: Device
intervention name: Tandem t:slim X2 Insulin Pump
description: sensor augmented insulin pump with predictive low glucose suspend
arm group label: Continuous Subcutaneous Insulin Infusion (CSII)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nick Oliver
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
url: https://www.nice.org.uk/guidance/ng17/resources/type-1-diabetes-in-adults-diagnosis-and-management-pdf-1837276469701
description: NICE Guidelines
responsible party type: Sponsor
mesh term: Hypoglycemia
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
sharing ipd: No
submitted: October 10, 2022
returned: August 25, 2023
submitted: September 14, 2023