<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/NCT02189135</url>
  </required_header>
  <id_info>
    <org_study_id>MRFAST</org_study_id>
    <nct_id>NCT02189135</nct_id>
  </id_info>
  <brief_title>Making Ramadhan Fasting a Safer Experience With Technology Study</brief_title>
  <official_title>Making Ramadhan Fasting a Safer Experience With Technology Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Monash University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Segi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Monash University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of&#xD;
      illness, disability, and death in Malaysia with an increasing prevalence. Despite the best&#xD;
      effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2&#xD;
      diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk&#xD;
      of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM&#xD;
      Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at&#xD;
      sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will&#xD;
      generally consume large quantities of fried and sugary foods when they break their fast or&#xD;
      during the night. Given the importance and public health significance of poor diabetes&#xD;
      management and its associated risk especially during Ramadan, the investigators aim to test&#xD;
      the intervention of using remote monitoring within community provider practice for patients&#xD;
      with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer&#xD;
      which can directly feedback the patients glycaemic levels to the physicians will reduce and&#xD;
      even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain&#xD;
      euglycaemic throughout the whole Ramadan month.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible participants will be assigned based upon their participating site. Treatment&#xD;
      assignments are unmasked. Intervention group will utilize a web enabled glucometer&#xD;
      manufactured by Entra Health System (San Diego, California). The glucometer acts by&#xD;
      automatically uploading any glucose readings to an online portal currently managed by Entra&#xD;
      Health System. The web portal would host the patient's raw blood glucose in a logbook form&#xD;
      and laboratory data. A summary of the patient's gylcaemic and metabolic control (lipid, blood&#xD;
      pressure, weight) control, self-management skills as well as compliance to other key measures&#xD;
      such as eye examination, screening for microvascular complications would also be provided if&#xD;
      available. All patients in this intervention arm would be given a system-driven guidance on&#xD;
      when to test their blood glucose based on their disease status, medication regimen, and time&#xD;
      of poorest control so that the most useful, patient specific blood profile can be created and&#xD;
      used for future self-management coaching for patient.&#xD;
&#xD;
      In the event that there is 3 continuous readings of hypoglycaemia (3.9mmol/L and below) or&#xD;
      hyperglycaemia (11.1mmol/L and above), the system will automatically generate a message to&#xD;
      inform the attending physician. The physician then has an option to use this information, but&#xD;
      will remain responsible for all treatment decisions. For quality assurance, the physicians&#xD;
      will be required to periodically review the participant's electronic logbook data and summary&#xD;
      analysis reports, generated for patients and physicians. These feedbacks will be entered into&#xD;
      an electronic logbook and captured real-time. A report will be generated summarizing the&#xD;
      self-management actions for improving their diabetes control will be sent to the patients,&#xD;
      physicians as well as family member every month. Each patient will also be informed that&#xD;
      action plan serves as a pre-visit summary for the patient's next visit to their physician. In&#xD;
      addition, the participant's family member(s) will also be invited to participate and if&#xD;
      consented updated on the status of the participants blood glucose status periodically and be&#xD;
      prompted whenever their glycaemic levels are beyond the target.&#xD;
&#xD;
      Participants assigned to the control group will continue to receive their usual medical care&#xD;
      as they would from their physician or general practitioner including checking patient&#xD;
      self-management blood glucose and log books. In addition, participants will receive standard&#xD;
      lifestyle advice and will be given basic information on diabetes prevention, weight loss,&#xD;
      diet, and exercise consistent with expert recommendation for a healthy lifestyle.&#xD;
      Participants will also receive a glucose meter and supplies for 3 months. Participants will&#xD;
      be told to use the glucose meter as recommended by their physicians. Control participants&#xD;
      will also receive publically available literatures such as flyers and brochures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan</measure>
    <time_frame>Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in fructosamine from start of Ramadan (day -1) to end of Ramadan (day 29) in usual care versus telemedicine</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of hypoglycaemic rates in usual care versus telemedicine during Ramadan</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of hypoglycaemic rates in usual care versus telemedicine from baseline to end of treatment</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycaemic control of patients measured with HbA1c in patients under usual care versus telemedicine from baseline to end of treatment</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Diabetes Mellitus, Non-Insulin-Dependent</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care from physician/ doctor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telemedicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobile wireless glucometer with feedback from physicians</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemedicine</intervention_name>
    <description>The glucometer acts by automatically uploading any glucose readings to an online portal. A summary of the patient's glycaemic and metabolic control, self-management skills as well as compliance to other key measures such as eye examination, screening for microvascular complications would also be provided if available. All patients in this intervention arm would be given a system-driven guidance on when to test their blood glucose based on their disease status, medication regimen, and time of poorest control so that the most useful, patient specific blood profile can be created and used for future self-management coaching for patient</description>
    <arm_group_label>Telemedicine</arm_group_label>
    <other_name>Myglucohealth wireless bluetooth glucometer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes diagnosed by a physician at least six months prior to study&#xD;
             enrollment. This will be determined via self-report with verification (medical&#xD;
             records, current treatment, or test results meeting the 2009 Malaysian Clinical&#xD;
             Practice Guideline for Management of Type 2 Diabetes Mellitus (4th edition) criteria&#xD;
             of fasting blood glucose &gt; 7.0 mmol/L , symptoms of hyperglycaemia with casual plasma&#xD;
             glucose &gt;11.1mmol/L or two-hour plasma glucose &gt;11.1mmol/L after a 75gram oral glucose&#xD;
             load)&#xD;
&#xD;
          -  HbA1c of &gt; 7.5% but less than 11.0% within the most recent 3 months. Individuals with&#xD;
             HbA1c exceeding this level may require more urgent care and as such will be asked to&#xD;
             seek treatment&#xD;
&#xD;
          -  Aged 18 - 75 years are eligible. Participants older than 75 years of age are excluded&#xD;
             due to the increased risk of competing mortality and potential safety concerns related&#xD;
             to hypoglycaemia&#xD;
&#xD;
          -  Willing or has an intention to fast for at least 15 days during Ramadan&#xD;
&#xD;
          -  Access to internet and an e-mail address , or access to a smartphone with 3G services&#xD;
             in the intervention group&#xD;
&#xD;
          -  Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any&#xD;
             other conditions that can impede participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to give informed consent or communicate with local study staff&#xD;
&#xD;
          -  Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder&#xD;
&#xD;
          -  Hospitalization for depression in past six months&#xD;
&#xD;
          -  Plans to relocate to an area or travel plans that do not permit full participation in&#xD;
             the study&#xD;
&#xD;
          -  Lack of support from primary health care provider or family members&#xD;
&#xD;
          -  History of bariatric surgery, small bowel resection, or extensive bowel resection&#xD;
&#xD;
          -  Currently pregnant or nursing&#xD;
&#xD;
          -  Cancer: requiring treatment in the past five years, except for non-melanoma skin&#xD;
             cancers or cancers that have clearly been cured or in the opinion of the investigator&#xD;
             carry an excellent prognosis (e.g., Stage 1 cervical cancer)&#xD;
&#xD;
          -  Cardiovascular disease (heart attack or procedure within the past three months or&#xD;
             participation in a cardiac rehabilitation program within last three months, stroke or&#xD;
             history/treatment for transient ischemic attacks in the past three months, or&#xD;
             documented history of pulmonary embolus in past six months)&#xD;
&#xD;
          -  Other medical, psychiatric, or behavioral factors that in the judgment of the&#xD;
             Principal Investigator may interfere with study participation or the ability to follow&#xD;
             the intervention protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaun Lee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monash University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik Kesihatan Pandamaran</name>
      <address>
        <city>Klang</city>
        <state>Selangor</state>
        <zip>42000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Monash University</investigator_affiliation>
    <investigator_full_name>Shaun Lee Wen Huey</investigator_full_name>
    <investigator_title>Shaun Lee</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02189135
org study id: MRFAST
nct id: NCT02189135
lead sponsor: 
collaborator: 
has dmc: No
Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of
      illness, disability, and death in Malaysia with an increasing prevalence. Despite the best
      effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2
      diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk
      of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM
      Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at
      sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will
      generally consume large quantities of fried and sugary foods when they break their fast or
      during the night. Given the importance and public health significance of poor diabetes
      management and its associated risk especially during Ramadan, the investigators aim to test
      the intervention of using remote monitoring within community provider practice for patients
      with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer
      which can directly feedback the patients glycaemic levels to the physicians will reduce and
      even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain
      euglycaemic throughout the whole Ramadan month.
Eligible participants will be assigned based upon their participating site. Treatment
      assignments are unmasked. Intervention group will utilize a web enabled glucometer
      manufactured by Entra Health System (San Diego, California). The glucometer acts by
      automatically uploading any glucose readings to an online portal currently managed by Entra
      Health System. The web portal would host the patient's raw blood glucose in a logbook form
      and laboratory data. A summary of the patient's gylcaemic and metabolic control (lipid, blood
      pressure, weight) control, self-management skills as well as compliance to other key measures
      such as eye examination, screening for microvascular complications would also be provided if
      available. All patients in this intervention arm would be given a system-driven guidance on
      when to test their blood glucose based on their disease status, medication regimen, and time
      of poorest control so that the most useful, patient specific blood profile can be created and
      used for future self-management coaching for patient.

      In the event that there is 3 continuous readings of hypoglycaemia (3.9mmol/L and below) or
      hyperglycaemia (11.1mmol/L and above), the system will automatically generate a message to
      inform the attending physician. The physician then has an option to use this information, but
      will remain responsible for all treatment decisions. For quality assurance, the physicians
      will be required to periodically review the participant's electronic logbook data and summary
      analysis reports, generated for patients and physicians. These feedbacks will be entered into
      an electronic logbook and captured real-time. A report will be generated summarizing the
      self-management actions for improving their diabetes control will be sent to the patients,
      physicians as well as family member every month. Each patient will also be informed that
      action plan serves as a pre-visit summary for the patient's next visit to their physician. In
      addition, the participant's family member(s) will also be invited to participate and if
      consented updated on the status of the participants blood glucose status periodically and be
      prompted whenever their glycaemic levels are beyond the target.

      Participants assigned to the control group will continue to receive their usual medical care
      as they would from their physician or general practitioner including checking patient
      self-management blood glucose and log books. In addition, participants will receive standard
      lifestyle advice and will be given basic information on diabetes prevention, weight loss,
      diet, and exercise consistent with expert recommendation for a healthy lifestyle.
      Participants will also receive a glucose meter and supplies for 3 months. Participants will
      be told to use the glucose meter as recommended by their physicians. Control participants
      will also receive publically available literatures such as flyers and brochures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan
time frame: Week 4
measure: Mean change in fructosamine from start of Ramadan (day -1) to end of Ramadan (day 29) in usual care versus telemedicine
time frame: Week 4
measure: Total number of hypoglycaemic rates in usual care versus telemedicine during Ramadan
time frame: Week 4
measure: Total number of hypoglycaemic rates in usual care versus telemedicine from baseline to end of treatment
time frame: Week 12
measure: Glycaemic control of patients measured with HbA1c in patients under usual care versus telemedicine from baseline to end of treatment
time frame: Week 12
arm group label: Usual care
arm group type: No Intervention
description: Usual care from physician/ doctor
arm group label: Telemedicine
arm group type: Experimental
description: Mobile wireless glucometer with feedback from physicians
intervention type: Device
intervention name: Telemedicine
description: The glucometer acts by automatically uploading any glucose readings to an online portal. A summary of the patient's glycaemic and metabolic control, self-management skills as well as compliance to other key measures such as eye examination, screening for microvascular complications would also be provided if available. All patients in this intervention arm would be given a system-driven guidance on when to test their blood glucose based on their disease status, medication regimen, and time of poorest control so that the most useful, patient specific blood profile can be created and used for future self-management coaching for patient
arm group label: Telemedicine
other name: Myglucohealth wireless bluetooth glucometer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shaun Lee, PhD
role: Principal Investigator
affiliation: Monash University
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Monash University
investigator full name: Shaun Lee Wen Huey
investigator title: Shaun Lee
mesh term: Diabetes Mellitus, Type 2