Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2018
CompletedFirst Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2019
CompletedOctober 2, 2019
September 1, 2019
8 months
November 28, 2018
September 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.
3 months
Study Arms (1)
Pet Fish
EXPERIMENTALParticipants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months
Interventions
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: 1. feed fish one pellet in the morning after waking; check and record BG reading at that time 2. feed fish one pellet in the evening before dinner; check and record BG reading at that time 3. feed fish one pellet at night before bedtime; check and record BG reading at that time 4. 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.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 28, 2018
First Posted
December 3, 2018
Study Start
October 31, 2018
Primary Completion
July 9, 2019
Study Completion
September 25, 2019
Last Updated
October 2, 2019
Record last verified: 2019-09