<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/NCT02230137</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00915-42</org_study_id>
    <nct_id>NCT02230137</nct_id>
  </id_info>
  <brief_title>Text Message for Adolescents With Poorly Controlled Type 1 Diabetes</brief_title>
  <acronym>Diabeto-SMS</acronym>
  <official_title>Impact of Mobile Phone Short Text Messages on the Glycaemic Control of Adolescents With Poorly Controlled Type 1 Diabetes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess HbA1c reduction after supportive care by SMS among&#xD;
      adolescents with poorly controlled type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2010, the number of children with type 1 diabetes in France is estimated at 12,000 with&#xD;
      60% of them aged 12 to 17 years. Compliance is a major issue during adolescence. Mobile text&#xD;
      message is one of the strategies to enhance adherence. The main aim of this study is to&#xD;
      assess HbA1c reduction after a 6 month SMS support among adolescents with poorly controlled&#xD;
      type 1 diabetes. Adherence and quality of life will also be assessed at the end of the trial.&#xD;
      This study is a prospective randomized monocentric trial. Sixty adolescents with type 1&#xD;
      diabetes and HbA1c equal or higher than 8.5 % will be randomized according to the method of&#xD;
      Zelen in two groups : standard treatment versus standard treatment plus support by SMS. The&#xD;
      patients will receive one SMS before each injection of insulin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c level</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c level</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>3 months</time_frame>
    <description>blood glucose level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>6 months</time_frame>
    <description>blood glucose level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>PedsQL version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>PedsQL version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction survey</measure>
    <time_frame>6 months</time_frame>
    <description>7 items for patients randomized in the &quot;Text message arm&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Text message arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No text message arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text message arm</intervention_name>
    <description>Text message sent before each injection of insulin</description>
    <arm_group_label>Text message arm</arm_group_label>
    <other_name>Mobile phone short text message</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 12 and 21 years old&#xD;
&#xD;
          -  with type 1 diabetes for more than 6 months&#xD;
&#xD;
          -  HbA1c at enrollment &gt; 8.5%&#xD;
&#xD;
          -  non-opposition of one of the parents&#xD;
&#xD;
          -  previous medical exam (art. L.1121-11 du CSP)&#xD;
&#xD;
          -  Possible follow-up for 6 months&#xD;
&#xD;
          -  social welfare coverage&#xD;
&#xD;
          -  Adolescents with a mobile phone, able to receive short text message&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aged less than 12 or higher than 21 years old&#xD;
&#xD;
          -  with HbA1c at enrollment &lt; 8.5%&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  psychiatric disease&#xD;
&#xD;
          -  do not understand french&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marc Tréluyer, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AP-HP Necker</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Louch G, Dalkin S, Bodansky J, Conner M. An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. Psychol Health Med. 2013;18(2):166-74. doi: 10.1080/13548506.2012.689841. Epub 2012 May 30.</citation>
    <PMID>22646659</PMID>
  </reference>
  <reference>
    <citation>Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.</citation>
    <PMID>17395516</PMID>
  </reference>
  <reference>
    <citation>Rami B, Popow C, Horn W, Waldhoer T, Schober E. Telemedical support to improve glycemic control in adolescents with type 1 diabetes mellitus. Eur J Pediatr. 2006 Oct;165(10):701-5. doi: 10.1007/s00431-006-0156-6. Epub 2006 May 3.</citation>
    <PMID>16670859</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>July 19, 2016</last_update_submitted>
  <last_update_submitted_qc>July 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adolescents</keyword>
  <keyword>type 1 diabetes</keyword>
  <keyword>poorly controlled</keyword>
  <keyword>SMS</keyword>
  <keyword>Improve glycaemic control</keyword>
  <keyword>HbA1c reduction</keyword>
  <keyword>poorly controlled type 1 diabetic adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02230137
org study id: 2014-A00915-42
nct id: NCT02230137
lead sponsor: 
has dmc: No
The purpose of this study is to assess HbA1c reduction after supportive care by SMS among
      adolescents with poorly controlled type 1 diabetes.
In 2010, the number of children with type 1 diabetes in France is estimated at 12,000 with
      60% of them aged 12 to 17 years. Compliance is a major issue during adolescence. Mobile text
      message is one of the strategies to enhance adherence. The main aim of this study is to
      assess HbA1c reduction after a 6 month SMS support among adolescents with poorly controlled
      type 1 diabetes. Adherence and quality of life will also be assessed at the end of the trial.
      This study is a prospective randomized monocentric trial. Sixty adolescents with type 1
      diabetes and HbA1c equal or higher than 8.5 % will be randomized according to the method of
      Zelen in two groups : standard treatment versus standard treatment plus support by SMS. The
      patients will receive one SMS before each injection of insulin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: HbA1c level
time frame: 6 months
measure: HbA1c level
time frame: 3 months
measure: Compliance
time frame: 3 months
description: blood glucose level
measure: Compliance
time frame: 6 months
description: blood glucose level
measure: Quality of life
time frame: 3 months
description: PedsQL version 4.0
measure: Quality of life
time frame: 6 months
description: PedsQL version 4.0
measure: Satisfaction survey
time frame: 6 months
description: 7 items for patients randomized in the "Text message arm"
arm group label: Text message arm
arm group type: Experimental
arm group label: No text message arm
arm group type: No Intervention
intervention type: Behavioral
intervention name: Text message arm
description: Text message sent before each injection of insulin
arm group label: Text message arm
other name: Mobile phone short text message
criteria: 
gender: All
minimum age: 12 Years
maximum age: 20 Years
healthy volunteers: No
last name: Jean-Marc Tréluyer, MD, PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: Louch G, Dalkin S, Bodansky J, Conner M. An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. Psychol Health Med. 2013;18(2):166-74. doi: 10.1080/13548506.2012.689841. Epub 2012 May 30.
PMID: 22646659
citation: Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.
PMID: 17395516
citation: Rami B, Popow C, Horn W, Waldhoer T, Schober E. Telemedical support to improve glycemic control in adolescents with type 1 diabetes mellitus. Eur J Pediatr. 2006 Oct;165(10):701-5. doi: 10.1007/s00431-006-0156-6. Epub 2006 May 3.
PMID: 16670859
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No