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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761251
• Other study ID #: 2018-0044
• Status: Completed
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: September 25, 2019

Study information

• Verified date: September 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 25, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adolescent Behavior
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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: 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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.	3 months