NCT01733524

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 2, 2016

Status Verified

June 1, 2016

Enrollment Period

3.2 years

First QC Date

November 2, 2012

Last Update Submit

June 1, 2016

Conditions

Type 1 Diabetes Mellitus

Keywords

adolescenceself care

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    Hemoglobin A1c values

    12 months

Secondary Outcomes (2)

  • HRQoL

    9 months

  • Self Management of Diabetes in Adolescents

    12 months

Other Outcomes (1)

  • Health care burden

    12 months

Study Arms (2)

Picture of a fish

SHAM COMPARATOR

Participants will receive a picture of a betta fish.

Behavioral: Picture of a fish

Pet fish

ACTIVE COMPARATOR

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

Behavioral: Pet Fish

Interventions

Pet FishBEHAVIORAL

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

Pet fish
Picture of a fishBEHAVIORAL

Participants will receive a picture of a betta fish.

Picture of a fish

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • English-speaking patients
  • 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%

You may not qualify if:

  • type 2 diabetes
  • developmental delay
  • current participation in another study that may impact glycemic control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Olga T Gupta, MD

    UT Southwestern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 27, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 2, 2016

Record last verified: 2016-06

Locations

US(1)