Pet Ownership and Glucose Control in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Impact of Pet Ownership on Glycemic Control in Youth With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733524
• Other study ID #: 1R03HD071263-01
• Status: Completed
• Phase: N/A
• First received: November 2, 2012
• Last updated: June 1, 2016
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators' long-term goal is to discover novel, inexpensive and feasible strategies to improve the management and well-being of youth with T1DM. The specific objective of this proposal is to quantify the impact of responsible pet ownership on the glycemic control and health related quality of life in youth with T1DM.

Description:

Type 1 diabetes mellitus (T1DM) affects 151,000 children and adolescents in the United States. Youth with T1DM are at a high risk for multiple psychosocial co-morbidities including poor health related quality of life (HRQoL) which is linked to medication non-compliance and increased risk for diabetes-related complications. Any reduction in the psychosocial adjustment difficulties related to T1DM could improve the medical outcome of children with T1DM.

Current standards for diabetes management reflect the need to maintain glucose control within a normal range. However, numerous reports indicate that normalization of blood glucose levels is seldom attainable in children and adolescents. Family cohesion, positive coping strategies, younger age of onset, social support and adequate self-regulatory behavior are found to favorably influence glycemic control. One may conclude that the presence of a companion animal, capable of enhancing the positive factors named above, would augment the array of tools available for the successful management of chronic illnesses such as T1DM.

There is a lack of studies assessing the impact of pet ownership on the health and well-being of adolescents. The process of caring for, loving and being loved by a companion animal could offer direct and/or indirect benefits to the HRQoL in children with T1DM. To the investigators' knowledge, there are no studies examining the impact of pet ownership on glycemic control and HRQoL in youth with T1DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• English-speaking patients

• 10 to 18 years

• diagnosed with type 1 diabetes for at least 12 months

• poor diabetes control as defined by having a hemoglobin A1c value > 8%

Exclusion Criteria:

• type 2 diabetes

• developmental delay

• current participation in another study that may impact glycemic control

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Pet Fish
Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
• Picture of a fish
Participants will receive a picture of a betta fish.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health care burden	Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control	12 months	No
Primary	Glycemic control	Hemoglobin A1c values	12 months	No
Secondary	HRQoL	Generic and diabetes-specific health related quality of life	9 months	No
Secondary	Self Management of Diabetes in Adolescents	Self management of diabetes in adolescence questionnaire	12 months	No