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

Primary Purpose

Diabetes Mellitus, Type 1, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pet Fish
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

10 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pet Fish

Arm Description

Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2018
Last Updated
September 30, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03761251
Brief Title
Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
Official Title
Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Adolescent Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pet Fish
Arm Type
Experimental
Arm Description
Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Pet Fish
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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