<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/NCT03837262</url>
  </required_header>
  <id_info>
    <org_study_id>GLiMPSE-POC1</org_study_id>
    <nct_id>NCT03837262</nct_id>
  </id_info>
  <brief_title>GLucose Monitoring Programme SingaporeE (GLiMPSE)</brief_title>
  <acronym>GLiMPSE</acronym>
  <official_title>GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SingHealth Polyclinics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Singapore General Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to&#xD;
      evaluate the feasibility and acceptability of the flash glucose monitoring system together&#xD;
      with a structured education programme in individuals with Type 2 Diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore.&#xD;
&#xD;
      For Adults, this phase consists of screening and intervention periods.&#xD;
&#xD;
      Screening Period (Week -2 to -1):&#xD;
&#xD;
      Participants will be asked to wear a blinded flash glucose monitoring system and will be&#xD;
      asked to continue testing their capillary glucose readings at least once daily for 2 weeks&#xD;
      (week -2 to week -1). Sensor glucose measurements are not available to both participants and&#xD;
      investigators during this screening period. Participants who are able to wear the sensor for&#xD;
      the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for&#xD;
      the 2 weeks (&gt;10 readings/2weeks), will proceed on with the intervention period.&#xD;
&#xD;
      Intervention Period (Week 0 - 26):&#xD;
&#xD;
      Participants will wear a personal version of the flash glucose monitoring system continuously&#xD;
      for the next 6 weeks. After these 6 weeks, they will wear the sensor intermittently (one&#xD;
      sensor lasting 2 weeks, per 4 weeks) for the following 18 weeks.Participants in this arm will&#xD;
      receive an education package that consists of Diabetes nurse educator and/or dietitian&#xD;
      appointments during weeks 0, 2, 6 and 24. After week 24, they will put on a blinded sensor&#xD;
      for the last 2 weeks of the intervention period (week 25 to week 26). HbA1c will be monitored&#xD;
      at weeks 0, 14 and 24. Questionnaires will be administered to assess acceptability of wear,&#xD;
      and perceived value to the end-user.&#xD;
&#xD;
      Paediatric participants will not undergo blinded sensor wear but will undergo the&#xD;
      intervention period, with the schedule of wear identical to the adults'. The education&#xD;
      curriculum will be age-appropriate and will be delivered over weeks 0, 2, 6, 12, and 24.&#xD;
      Their HbA1c will be monitored at week 0, 12 and 24. Questionnaires will be administered to&#xD;
      assess acceptability of wear, and perceived value to the end-user.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 23, 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>Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment and retention</measure>
    <time_frame>26 weeks</time_frame>
    <description>Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>Questionnaire to assess the acceptability of wear of the flash glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>24 weeks</time_frame>
    <description>Measurement of HbA1c will be performed at baseline, week 12 and week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DSS questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>Diabetes Distress scale to be administered at baseline and week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L Questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>EQ-5D-5L Questionnaire to be administered at baseline and week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WPAI questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Flash glucose monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Flash Glucose Monitoring and structured education</intervention_name>
    <description>A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children</description>
    <arm_group_label>Flash glucose monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults&#xD;
&#xD;
          1. Adults (Age &gt; 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)&#xD;
&#xD;
          2. Singapore Citizen or Permanent Resident&#xD;
&#xD;
          3. Treatment with diet and exercise alone or other glucose-lowering therapies except&#xD;
             prandial insulin. GLP-1 agonists and / or basal insulin (NPH insulin, Insulin Lantus,&#xD;
             Insulin Toujeo, Insulin Detemir) are permitted.&#xD;
&#xD;
          4. Self-reported regular blood glucose testing via CBG (more than 3/week)&#xD;
&#xD;
        Children&#xD;
&#xD;
          1. Children and adolescents (Age between 12 and 21 years old) with Type 2 diabetes and&#xD;
             HbA1c &gt;8% at the time of enrolment&#xD;
&#xD;
          2. Singapore Citizen or Permanent Resident&#xD;
&#xD;
          3. Insulin replacement as part of diabetes management&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age above 75 years&#xD;
&#xD;
          2. Type 1 diabetes, monogenic diabetes&#xD;
&#xD;
          3. Prandial insulin (quick-acting insulin or premixed insulin)&#xD;
&#xD;
          4. Cancer requiring treatment in the past 5 years&#xD;
&#xD;
          5. Chronic renal failure (eGFR&lt;45ml/min) or dialysis&#xD;
&#xD;
          6. Amputation of lower limbs (excluding toe amputations)&#xD;
&#xD;
          7. Bariatric surgery for weight loss&#xD;
&#xD;
          8. Current systemic treatment with steroids&#xD;
&#xD;
          9. Pregnancy, attempting pregnancy or lactation.&#xD;
&#xD;
         10. Haemolytic anaemia or haemoglobinopathy&#xD;
&#xD;
         11. Prior use of the flash glucose monitoring system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daphne SL Gardner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore General Hospital, SingHealth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169856</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KKH</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pasir Ris Polyclinic</name>
      <address>
        <city>Singapore</city>
        <zip>519457</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>September 6, 2020</last_update_submitted>
  <last_update_submitted_qc>September 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Flash Glucose Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03837262
org study id: GLiMPSE-POC1
nct id: NCT03837262
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to
      evaluate the feasibility and acceptability of the flash glucose monitoring system together
      with a structured education programme in individuals with Type 2 Diabetes.
Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore.

      For Adults, this phase consists of screening and intervention periods.

      Screening Period (Week -2 to -1):

      Participants will be asked to wear a blinded flash glucose monitoring system and will be
      asked to continue testing their capillary glucose readings at least once daily for 2 weeks
      (week -2 to week -1). Sensor glucose measurements are not available to both participants and
      investigators during this screening period. Participants who are able to wear the sensor for
      the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for
      the 2 weeks (>10 readings/2weeks), will proceed on with the intervention period.

      Intervention Period (Week 0 - 26):

      Participants will wear a personal version of the flash glucose monitoring system continuously
      for the next 6 weeks. After these 6 weeks, they will wear the sensor intermittently (one
      sensor lasting 2 weeks, per 4 weeks) for the following 18 weeks.Participants in this arm will
      receive an education package that consists of Diabetes nurse educator and/or dietitian
      appointments during weeks 0, 2, 6 and 24. After week 24, they will put on a blinded sensor
      for the last 2 weeks of the intervention period (week 25 to week 26). HbA1c will be monitored
      at weeks 0, 14 and 24. Questionnaires will be administered to assess acceptability of wear,
      and perceived value to the end-user.

      Paediatric participants will not undergo blinded sensor wear but will undergo the
      intervention period, with the schedule of wear identical to the adults'. The education
      curriculum will be age-appropriate and will be delivered over weeks 0, 2, 6, 12, and 24.
      Their HbA1c will be monitored at week 0, 12 and 24. Questionnaires will be administered to
      assess acceptability of wear, and perceived value to the end-user.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
primary purpose: Other
masking: None (Open Label)
measure: Recruitment and retention
time frame: 26 weeks
description: Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites
measure: Questionnaire
time frame: 24 weeks
description: Questionnaire to assess the acceptability of wear of the flash glucose monitoring system
measure: HbA1c
time frame: 24 weeks
description: Measurement of HbA1c will be performed at baseline, week 12 and week 24
measure: DSS questionnaire
time frame: 24 weeks
description: Diabetes Distress scale to be administered at baseline and week 24
measure: EQ-5D-5L Questionnaire
time frame: 24 weeks
description: EQ-5D-5L Questionnaire to be administered at baseline and week 24
measure: WPAI questionnaire
time frame: 24 weeks
description: Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24
arm group label: Flash glucose monitoring
arm group type: Experimental
description: Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education
intervention type: Combination Product
intervention name: Flash Glucose Monitoring and structured education
description: A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children
arm group label: Flash glucose monitoring
criteria: 
gender: All
minimum age: 12 Years
maximum age: 75 Years
healthy volunteers: No
last name: Daphne SL Gardner, MD
role: Principal Investigator
affiliation: Singapore General Hospital, SingHealth
facility: 
facility: 
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided