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Completed

NCT Number: NCT03761251

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

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.

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Key information

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pet Fish

Behavioral

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.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 3 months

    Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2018
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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