<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/NCT03761251</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0044</org_study_id>
    <nct_id>NCT03761251</nct_id>
  </id_info>
  <brief_title>Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes</brief_title>
  <official_title>Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This study evaluates the short-term effects of incorporating the structured care of a pet&#xD;
      fish into a diabetes self-care routine on glucose control in early adolescents with type 1&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to&#xD;
      self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time&#xD;
      for the deterioration of glycemic control in patients with T1DM. In particular, parental&#xD;
      monitoring declines during early adolescence. This often occurs before the child has&#xD;
      developed self-efficacy and competence in independently performing diabetes-related tasks,&#xD;
      including blood glucose monitoring. Consequently, there is a great need for innovative&#xD;
      strategies in early adolescents that promote self-efficacy development and facilitate&#xD;
      parental involvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2018</start_date>
  <completion_date type="Actual">September 25, 2019</completion_date>
  <primary_completion_date type="Actual">July 9, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>3 months</time_frame>
    <description>Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Pet Fish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pet Fish</intervention_name>
    <description>Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care:&#xD;
feed fish one pellet in the morning after waking; check and record BG reading at that time&#xD;
feed fish one pellet in the evening before dinner; check and record BG reading at that time&#xD;
feed fish one pellet at night before bedtime; check and record BG reading at that time&#xD;
every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern.&#xD;
Each child will also receive two books intended to supplement and enrich their pet fish experience.</description>
    <arm_group_label>Pet Fish</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 10-13 years&#xD;
&#xD;
          -  diagnosis of T1DM&#xD;
&#xD;
          -  duration of T1DM for at least one year&#xD;
&#xD;
          -  fluency in English&#xD;
&#xD;
          -  two recent consecutive HbA1c values 8.0 - 13%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical or laboratory characteristics suggestive of type 2 diabetes mellitus&#xD;
&#xD;
          -  involvement in foster care&#xD;
&#xD;
          -  dual-home living situation&#xD;
&#xD;
          -  severe psychiatric disorders&#xD;
&#xD;
          -  developmental delay or cognitive impairment&#xD;
&#xD;
          -  current participation in another study that may impact glycemic control&#xD;
&#xD;
          -  regular usage of a continuous glucose monitor&#xD;
&#xD;
          -  HbA1c &gt; 13% (because these individuals may need a more intensive intervention than&#xD;
             this is intended to provide).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Olga Gupta</investigator_full_name>
    <investigator_title>Assistant Professor</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 1</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/NCT03761251
org study id: 2018-0044
nct id: NCT03761251
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the short-term effects of incorporating the structured care of a pet
      fish into a diabetes self-care routine on glucose control in early adolescents with type 1
      diabetes.
Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to
      self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time
      for the deterioration of glycemic control in patients with T1DM. In particular, parental
      monitoring declines during early adolescence. This often occurs before the child has
      developed self-efficacy and competence in independently performing diabetes-related tasks,
      including blood glucose monitoring. Consequently, there is a great need for innovative
      strategies in early adolescents that promote self-efficacy development and facilitate
      parental involvement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hemoglobin A1c
time frame: 3 months
description: Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.
arm group label: Pet Fish
arm group type: Experimental
description: Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months
intervention type: Behavioral
intervention name: Pet Fish
description: Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care:
feed fish one pellet in the morning after waking; check and record BG reading at that time
feed fish one pellet in the evening before dinner; check and record BG reading at that time
feed fish one pellet at night before bedtime; check and record BG reading at that time
every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern.
Each child will also receive two books intended to supplement and enrich their pet fish experience.
arm group label: Pet Fish
criteria: 
gender: All
minimum age: 10 Years
maximum age: 13 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Olga Gupta
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1