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OpenTrials
Completed

NCT Number: NCT01733524

Pet Ownership and Glucose Control in Type 1 Diabetes

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.

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Key information

Age range

10 year–17 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

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pet Fish

Behavioral

Participants will receive a betta fish and the supplies to care for the fish for a one year time period.

Picture of a fish

Behavioral

Participants will receive a picture of a betta fish.

Primary outcomes

  1. Glycemic control

    Time frame: 12 months

    Hemoglobin A1c values

Secondary outcomes

  1. HRQoL

    Time frame: 9 months

    Generic and diabetes-specific health related quality of life

  2. Self Management of Diabetes in Adolescents

    Time frame: 12 months

    Self management of diabetes in adolescence questionnaire

Other outcomes

  1. Health care burden

    Time frame: 12 months

    Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • University of Massachusetts, Worcester

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2012
Registry last updated
Jun 2, 2016

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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