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CompletedNCT03761251Updated Oct 2, 2019

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

An interventional study of Pet Fish in Diabetes Mellitus, Type 1 and Adolescent Behavior, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 10 Years to 13 Years. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
10 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
  • Adolescent Behavior
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 15 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.

Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralPet 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.

06

What researchers measure

Primary outcomes

  1. Hemoglobin A1c

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

    Time frame: 3 months

07

Study locations

1 site
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03761251
Responsible party
Olga Gupta (Assistant Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Dec 3, 2018
Start date
Oct 31, 2018
Primary completion
Jul 9, 2019
Completion
Sep 25, 2019
Last update
Oct 2, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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