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Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03761251
Recruitment Status : Enrolling by invitation
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Olga Gupta, University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Adolescent Behavior Behavioral: Pet Fish Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Pet Fish
Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months
Behavioral: Pet Fish

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:

  1. feed fish one pellet in the morning after waking; check and record BG reading at that time
  2. feed fish one pellet in the evening before dinner; check and record BG reading at that time
  3. feed fish one pellet at night before bedtime; check and record BG reading at that time
  4. 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.





Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 3 months ]
    Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.



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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 10-13 years
  • diagnosis of T1DM
  • duration of T1DM for at least one year
  • fluency in English
  • two recent consecutive HbA1c values 8.0 - 13%

Exclusion Criteria:

  • clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
  • involvement in foster care
  • dual-home living situation
  • severe psychiatric disorders
  • developmental delay or cognitive impairment
  • current participation in another study that may impact glycemic control
  • regular usage of a continuous glucose monitor
  • HbA1c > 13% (because these individuals may need a more intensive intervention than this is intended to provide).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761251


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center

Responsible Party: Olga Gupta, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03761251     History of Changes
Other Study ID Numbers: 2018-0044
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases