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/NCT06033872</url>
    </required_header>
    <id_info>
      <org_study_id>2019/2888</org_study_id>
      <nct_id>NCT06033872</nct_id>
    </id_info>
    <brief_title>Effectiveness of Education, Medication Adjustment and Telemonitoring in Reducing Diabetes Complications During Ramadan</brief_title>
    <official_title>Effectiveness of Diabetes Education and Medication Adjustment With Telemonitoring Intervention in Reducing Diabetes Complications During Ramadan Fasting - a Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sengkang General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>SingHealth Polyclinics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Singapore Clinical Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sengkang General Hospital</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>
        Introduction Diabetes is a global emergency with detrimental clinical and financial&#xD;
        consequences. Poorly managed diabetes leads to a myriad of serious complications, especially&#xD;
        cardiovascular and infectious complications, with consequent increased cost and mortality&#xD;
        rate. For Muslims in particular, the annual fasting month of Ramadan is one such period when&#xD;
        diabetes control is essential. Adequate adjustments in diabetes management need to be made in&#xD;
        line with the allowed meal times to avoid the risk of diabetes complications during Ramadan.&#xD;
  &#xD;
        Objective Investigators aim to investigate the effectiveness of focused diabetes education&#xD;
        and medication adjustment with telemonitoring to reduce diabetes complications during Ramadan&#xD;
        fasting as well as to assess the cost-effectiveness of this intervention for Muslims with&#xD;
        diabetes in Singapore.&#xD;
  &#xD;
        Methodology In a parallel group randomized controlled trial, investigators aim to recruit 100&#xD;
        adults with diabetes who are able to fast at least 15 days in Ramadan. You will be randomized&#xD;
        to the intervention group comprising of focused diabetes education, medication adjustment and&#xD;
        telemonitoring, and control group receiving standard care. You will be followed up during&#xD;
        Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary&#xD;
        outcomes are (i) incidence of other diabetes complications in Ramadan episodes including&#xD;
        hyperglycemia, episodes of acute infections, attendances in clinic and emergency department&#xD;
        and that of hospital admission, and (ii) cost-effectiveness of the intervention.&#xD;
  &#xD;
        Clinical Significance The study enables investigators to evaluate focused pre-Ramadan&#xD;
        diabetes education and medication adjustment with tele-monitoring as a means to reduce the&#xD;
        markedly increased risk of diabetes complications for a large population during the fasting&#xD;
        month, with potential for increased cost-effectiveness through reducing unscheduled&#xD;
        attendances at clinic and hospital.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 25, 2021</start_date>
    <completion_date type="Actual">May 31, 2022</completion_date>
    <primary_completion_date type="Actual">September 1, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan</measure>
      <time_frame>30 day</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>i. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan when compared to before and after Ramadan</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ii. To compare the first incidence rate of complications in Ramadan when compared to before and after 1. Hyperglycemia and crises 2. Acute infections, clinic and emergency department attendances and hospital admissions</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality-of-Life using European Quality of Life Five Dimensions (EQ-5D) - to provide a summary of index value of health and health change, cost-utility calculation.</measure>
      <time_frame>17 weeks</time_frame>
      <description>Five dimensions are mobility, self-care, usual activities, pain or discomfort and anxiety or depression. Scored health as 0 to 100 where 0 is worst and 100 is best</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare utilizations costs - Medical services, drugs and devices utilized, outpatient and inpatient visits, cost of intervention sessions, telemonitoring and equipment, indirect costs related to health care utilisation, and caregiver costs.</measure>
      <time_frame>17 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">79</enrollment>
    <condition>Diabetes Mellitus</condition>
    <condition>Fasting</condition>
    <condition>Diabetes Complications</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Focused education, medication adjustment and telemonitoring</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard care</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Focused education, medication adjustment and telemonitoring</intervention_name>
      <description>Focused diabetes education session for Ramadan fasting&#xD;
  You will be taught to record&#xD;
  Meal plans&#xD;
  Physical activities&#xD;
  Blood glucose monitoring, and&#xD;
  Monitoring for diabetes complications. Then perform a trial fasting day prior to Ramadan when control is not optimal or medication with risk of hypoglycemia.&#xD;
  Medication adjustment for Ramadan fasting You will be provided regimen modified for Ramadan fasting.&#xD;
  Telemonitoring&#xD;
  You will be taught to perform blood glucose monitoring 4 times daily using a glucometer and upload recordings of glucose levels onto the data software.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          You must meet all of the inclusion criteria to participate in this study:&#xD;
  &#xD;
            1. Adults aged at least 21 years old,&#xD;
  &#xD;
            2. Able to fast at least 15 days in Ramadan based on experience of fasting in previous&#xD;
               year's Ramadan,&#xD;
  &#xD;
            3. Known physician-diagnosed diabetes mellitus (DM) based on the following criteria&#xD;
               before starting treatment&#xD;
  &#xD;
               a. Symptoms of polyuria, polydipsia and unexplained weight loss with i. fasting&#xD;
               glucose ≥ 7.0mmol/l or ii. random plasma glucose ≥ 11.1 mmol/l or iii. 2-hour post 75g&#xD;
               oral glucose challenge test plasma glucose ≥ 11.1 mmol/l b. Absence of symptoms of&#xD;
               polyuria, polydipsia and unexplained weight loss with the following tests done twice&#xD;
               showing the values i. fasting glucose ≥ 7.0mmol/l or ii. random plasma glucose ≥ 11.1&#xD;
               mmol/l or iii. 2-hour post 75g oral glucose challenge test plasma glucose ≥ 11.1&#xD;
               mmol/l&#xD;
  &#xD;
            4. Performed laboratory tests as per standard care : serum glycated hemoglobin A1c&#xD;
               (HbA1c) level, blood Low Density Lipoprotein-Cholesterol, blood triglyceride level,&#xD;
               blood High Density Lipoprotein-Cholesterol, blood Total Cholesterol and serum&#xD;
               creatinine&#xD;
  &#xD;
            5. Most recent HbA1c level was &gt;7.0% (&gt;53mmol/mol)&#xD;
  &#xD;
            6. Ability to give informed consent,&#xD;
  &#xD;
            7. Ability to perform weekly recordings in the diary,&#xD;
  &#xD;
            8. Able to use and owns a mobile phone for recordings on mobile application&#xD;
  &#xD;
            9. Should have had DM-related clinic visits or hospitalization in the past 10 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Meeting any of the exclusion criteria at baseline will exclude you from participation:&#xD;
  &#xD;
            1. Severe diabetes complications including end-stage renal failure, severe hypoglycemia&#xD;
               and hyperglycemic crises within the last 1 month negating ability to fast,&#xD;
  &#xD;
            2. Pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sueziani B Zainudin, MBBS FRCPG</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sengkang General Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Sengkang General Hospital</name>
        <address>
          <city>Singapore</city>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>
      <mesh_term>Diabetes Complications</mesh_term>
    </condition_browse>
    <!-- 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/NCT06033872
  org study id: 2019/2888
  nct id: NCT06033872
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Introduction Diabetes is a global emergency with detrimental clinical and financial
        consequences. Poorly managed diabetes leads to a myriad of serious complications, especially
        cardiovascular and infectious complications, with consequent increased cost and mortality
        rate. For Muslims in particular, the annual fasting month of Ramadan is one such period when
        diabetes control is essential. Adequate adjustments in diabetes management need to be made in
        line with the allowed meal times to avoid the risk of diabetes complications during Ramadan.
  
        Objective Investigators aim to investigate the effectiveness of focused diabetes education
        and medication adjustment with telemonitoring to reduce diabetes complications during Ramadan
        fasting as well as to assess the cost-effectiveness of this intervention for Muslims with
        diabetes in Singapore.
  
        Methodology In a parallel group randomized controlled trial, investigators aim to recruit 100
        adults with diabetes who are able to fast at least 15 days in Ramadan. You will be randomized
        to the intervention group comprising of focused diabetes education, medication adjustment and
        telemonitoring, and control group receiving standard care. You will be followed up during
        Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary
        outcomes are (i) incidence of other diabetes complications in Ramadan episodes including
        hyperglycemia, episodes of acute infections, attendances in clinic and emergency department
        and that of hospital admission, and (ii) cost-effectiveness of the intervention.
  
        Clinical Significance The study enables investigators to evaluate focused pre-Ramadan
        diabetes education and medication adjustment with tele-monitoring as a means to reduce the
        markedly increased risk of diabetes complications for a large population during the fasting
        month, with potential for increased cost-effectiveness through reducing unscheduled
        attendances at clinic and hospital.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  measure: a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan
  time frame: 30 day
  measure: i. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan when compared to before and after Ramadan
  time frame: 12 weeks
  measure: ii. To compare the first incidence rate of complications in Ramadan when compared to before and after 1. Hyperglycemia and crises 2. Acute infections, clinic and emergency department attendances and hospital admissions
  time frame: 12 weeks
  measure: Health-related Quality-of-Life using European Quality of Life Five Dimensions (EQ-5D) - to provide a summary of index value of health and health change, cost-utility calculation.
  time frame: 17 weeks
  description: Five dimensions are mobility, self-care, usual activities, pain or discomfort and anxiety or depression. Scored health as 0 to 100 where 0 is worst and 100 is best
  measure: Healthcare utilizations costs - Medical services, drugs and devices utilized, outpatient and inpatient visits, cost of intervention sessions, telemonitoring and equipment, indirect costs related to health care utilisation, and caregiver costs.
  time frame: 17 weeks
  arm group label: Intervention
  arm group type: Active Comparator
  description: Focused education, medication adjustment and telemonitoring
  arm group label: Control
  arm group type: No Intervention
  description: Standard care
  intervention type: Combination Product
  intervention name: Focused education, medication adjustment and telemonitoring
  description: Focused diabetes education session for Ramadan fasting
  You will be taught to record
  Meal plans
  Physical activities
  Blood glucose monitoring, and
  Monitoring for diabetes complications. Then perform a trial fasting day prior to Ramadan when control is not optimal or medication with risk of hypoglycemia.
  Medication adjustment for Ramadan fasting You will be provided regimen modified for Ramadan fasting.
  Telemonitoring
  You will be taught to perform blood glucose monitoring 4 times daily using a glucometer and upload recordings of glucose levels onto the data software.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Sueziani B Zainudin, MBBS FRCPG
  role: Principal Investigator
  affiliation: Sengkang General Hospital
  facility: 
  country: Singapore
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Complications