<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/NCT03775057</url>
  </required_header>
  <id_info>
    <org_study_id>CIE01-18</org_study_id>
    <nct_id>NCT03775057</nct_id>
  </id_info>
  <brief_title>Use of the MyDose Coach Digital Tool for Self-titration of Insulin in Patients With Type 2 Diabetes</brief_title>
  <official_title>Use of the MyDose Coach Digital Tool for Self-titration of Insulin in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Dr. Jose E. Gonzalez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Clinica Nova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario Dr. Jose E. Gonzalez</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>
      Scientific studies show that the introduction of digital tools led to: Significant&#xD;
      improvement in glycemic control, greater patient satisfaction, reduction of emotional burden,&#xD;
      reduction of fear of hypoglycaemia, reduction of anxiety of the regimen, significantly fewer&#xD;
      of additional visits to the doctor in addition to those scheduled and a reduction of&#xD;
      resources.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To evaluate the efficacy and safety of the MyDose Coach digital tool in patients with T2D&#xD;
      with basal insulin or candidates for the use of basal insulin.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      Evaluate demographic variables and control variables (HbA1c, SMPG, FPG). Measure the units of&#xD;
      insulin used before and after the intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The maximum study duration will be 29 weeks per patient that will consist of a 12-week&#xD;
      screening period, a 16-week treatment period, and 1-week follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 22, 2018</start_date>
  <completion_date type="Anticipated">August 22, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 22, 2019</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients reaching fasting SMPG target without a severe hypoglycemic episode during the 16-week on-treatment period</measure>
    <time_frame>16 weeks</time_frame>
    <description>Percentage of patients reaching fasting SMPG (Self-Measured Plasma Glucose) target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 4 readings recorded over the last 2 weeks) without a severe hypoglycemic episode (defined as having low blood glucose levels that requires assistance from another person to treat) during the 16-week on-treatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean HbA1c change from baseline</measure>
    <time_frame>16 weeks</time_frame>
    <description>Mean Glycated hemoglobin A1c (in percentage) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients reaching HbA1c of &lt;7.5% and &lt;7%</measure>
    <time_frame>16 weeks</time_frame>
    <description>Percentage of patients reaching Glycated hemoglobin A1c of &lt;7.5% and &lt;7%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean fasting SMPG glucose change from baseline</measure>
    <time_frame>16 weeks</time_frame>
    <description>Mean fasting Self-Measured Plasma Glucose (mean of the last 4 readings recorded over the last 2 weeks, in mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach the first fasting SMPG target</measure>
    <time_frame>16 weeks</time_frame>
    <description>Time in weeks to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean FPG glucose change from baseline</measure>
    <time_frame>16 weeks</time_frame>
    <description>Mean fasting plasma glucose glucose change from baseline, in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with hypoglycemic events</measure>
    <time_frame>16 weeks</time_frame>
    <description>Percentage of patients with hypoglycemic events (blood glucose less than 70 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycemic events</measure>
    <time_frame>16 weeks</time_frame>
    <description>Number of hypoglycemic events (blood glucose less than 70 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with adverse events</measure>
    <time_frame>16 week</time_frame>
    <description>Percentage of patients with adverse events (other than hypoglycemia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of emotional well-being using WHO-5 well-being index</measure>
    <time_frame>16 week</time_frame>
    <description>Assessment of emotional well-being using WHO-5 well-being index. The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>MyDose Coach app intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention involves the use of the MyDose Coach application, which has been previously programmed with the following titration scheme according to fasting glucose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MyDoseCoach app</intervention_name>
    <description>The intervention involves the use of the MyDose Coach application, which has been previously programmed with the following titration scheme according to fasting glucose.</description>
    <arm_group_label>MyDose Coach app intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have type 2 diabetes&#xD;
&#xD;
          -  Greater than 18 years and up to 75 years of age&#xD;
&#xD;
          -  Use of basal insulin once a day or candidate for basal insulin once a day based on%&#xD;
             HbA1c according to international guidelines and doctor's criteria&#xD;
&#xD;
          -  HbA1c &gt; 7% in patients aged 18 to 65 years&#xD;
&#xD;
          -  HbA1c &gt; 7.5% in patients older than 65 years&#xD;
&#xD;
          -  Patients who use basal insulin twice a day or premix with diagnosed hypoglycemia and&#xD;
             who are candidates for switching from therapy to a basal insulin of one application&#xD;
             per day&#xD;
&#xD;
          -  Have a Smartphone&#xD;
&#xD;
          -  Informed consent signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuse to participate in the study.&#xD;
&#xD;
          -  Age younger than 18 years old and over 75 years old.&#xD;
&#xD;
          -  Diabetes type 1 or gestational (other than type 2 diabetes mellitus).&#xD;
&#xD;
          -  Patients with the following chronic complications of diabetes: retinopathy and chronic&#xD;
             kidney disease with a glomerular filtration rate &lt;30 ml / min.&#xD;
&#xD;
          -  The MyDose Coach tool is not appropriate for the patient or the use of the application&#xD;
             is contraindicated (in the opinion of the Researcher, for example, patients with&#xD;
             terminal illness, patients with cognitive or neurological disorders that are detailed&#xD;
             below, patients who live alone and they do not have support from the family, patients&#xD;
             with carpal tunnel who are not recommended to use a mobile phone, patients with&#xD;
             musculoskeletal injuries in their hands, etc.)&#xD;
&#xD;
          -  Patients who use insulin during the meal (short-acting analogue, regular human insulin&#xD;
             or insulin premix) for more than 10 days in the last 3 months before the screening&#xD;
             visit.&#xD;
&#xD;
          -  Patients with severe hypoglycemia in the last 90 days.&#xD;
&#xD;
          -  Hospitalization in the last 30 days (whatever the reason for hospitalization) In the&#xD;
             last 3 months prior to the screening period: history of myocardial infarction,&#xD;
             unstable angina, acute coronary syndrome, revascularization procedure, cerebrovascular&#xD;
             accident requiring hospitalization.&#xD;
&#xD;
          -  Severe or uncontrolled congestive heart failure (functional classification III and IV&#xD;
             of the New York Heart Association [NYHA]).&#xD;
&#xD;
          -  Use of systemic glucocorticoids (excluding topical application or inhaled forms) for a&#xD;
             week or more within 90 days prior to the time of the test.&#xD;
&#xD;
          -  Unable to meet specific protocol requirements (for example, inability to perform blood&#xD;
             glucose measurements, administer your own insulin dose, or consider it unlikely that&#xD;
             you will administer the titration safely according to your physician's guidance).&#xD;
&#xD;
          -  Patients with cognitive disorders, dementia or any neurological disorder that affects&#xD;
             the patient's ability to participate in the study, including the inability to&#xD;
             understand the requirements of the study or to provide complete information about the&#xD;
             adverse symptoms.&#xD;
&#xD;
          -  Pregnant or breast-feeding women or women who intend to become pregnant during the&#xD;
             study period.&#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_contact>
    <last_name>Hector Eloy Tamez, PhD</last_name>
    <phone>5218183483220</phone>
    <email>hectoreloytp@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clínica Nova</name>
      <address>
        <city>San Nicolás De Los Garza</city>
        <state>Nuevo León</state>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hector Eloy Tamez, PhD</last_name>
      <phone>5218183483220</phone>
      <email>hectoreloytp@gmail.com</email>
    </contact>
    <investigator>
      <last_name>David Soni, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oscar Cantu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rosalinda Gonzalez, BN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Dr. Jose E. Gonzalez</investigator_affiliation>
    <investigator_full_name>Dr. med. Hector Eloy Tamez Perez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <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/NCT03775057
org study id: CIE01-18
nct id: NCT03775057
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Scientific studies show that the introduction of digital tools led to: Significant
      improvement in glycemic control, greater patient satisfaction, reduction of emotional burden,
      reduction of fear of hypoglycaemia, reduction of anxiety of the regimen, significantly fewer
      of additional visits to the doctor in addition to those scheduled and a reduction of
      resources.

      Primary Objective:

      To evaluate the efficacy and safety of the MyDose Coach digital tool in patients with T2D
      with basal insulin or candidates for the use of basal insulin.

      Secondary Objectives:

      Evaluate demographic variables and control variables (HbA1c, SMPG, FPG). Measure the units of
      insulin used before and after the intervention
The maximum study duration will be 29 weeks per patient that will consist of a 12-week
      screening period, a 16-week treatment period, and 1-week follow-up period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of patients reaching fasting SMPG target without a severe hypoglycemic episode during the 16-week on-treatment period
time frame: 16 weeks
description: Percentage of patients reaching fasting SMPG (Self-Measured Plasma Glucose) target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 4 readings recorded over the last 2 weeks) without a severe hypoglycemic episode (defined as having low blood glucose levels that requires assistance from another person to treat) during the 16-week on-treatment period
measure: Mean HbA1c change from baseline
time frame: 16 weeks
description: Mean Glycated hemoglobin A1c (in percentage) from baseline
measure: Percentage of patients reaching HbA1c of <7.5% and <7%
time frame: 16 weeks
description: Percentage of patients reaching Glycated hemoglobin A1c of <7.5% and <7%
measure: Mean fasting SMPG glucose change from baseline
time frame: 16 weeks
description: Mean fasting Self-Measured Plasma Glucose (mean of the last 4 readings recorded over the last 2 weeks, in mg/dl)
measure: Time to reach the first fasting SMPG target
time frame: 16 weeks
description: Time in weeks to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L)
measure: Mean FPG glucose change from baseline
time frame: 16 weeks
description: Mean fasting plasma glucose glucose change from baseline, in mg/dl
measure: Percentage of patients with hypoglycemic events
time frame: 16 weeks
description: Percentage of patients with hypoglycemic events (blood glucose less than 70 mg/dL)
measure: Number of hypoglycemic events
time frame: 16 weeks
description: Number of hypoglycemic events (blood glucose less than 70 mg/dL)
measure: Percentage of patients with adverse events
time frame: 16 week
description: Percentage of patients with adverse events (other than hypoglycemia)
measure: Assessment of emotional well-being using WHO-5 well-being index
time frame: 16 week
description: Assessment of emotional well-being using WHO-5 well-being index. The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.
arm group label: MyDose Coach app intervention
arm group type: Experimental
description: The intervention involves the use of the MyDose Coach application, which has been previously programmed with the following titration scheme according to fasting glucose.
intervention type: Other
intervention name: MyDoseCoach app
description: The intervention involves the use of the MyDose Coach application, which has been previously programmed with the following titration scheme according to fasting glucose.
arm group label: MyDose Coach app intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hector Eloy Tamez, PhD
phone: 5218183483220
email: hectoreloytp@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Dr. Jose E. Gonzalez
investigator full name: Dr. med. Hector Eloy Tamez Perez
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided