Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility
NCT ID: NCT06598345
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
60 participants
INTERVENTIONAL
2025-04-16
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pet Fish with Integrated Diabetes Care + Collaborative Communication
Participants will receive specific instructions for coupling daily and weekly fish care and diabetes care throughout the 12-week intervention and how to conduct weekly collaborative communication meetings.
Routine Pet Fish Care
Participants in the Routine Group will be provided specific instructions for coupling the daily and weekly fish care and diabetes care throughout the 12-week intervention They will also be told to monitor BG four times daily, review BG readings with their parent weekly and document the BG checks and weekly reviews on their device's software.
Collaborative Communication
Parents and participants in the Collaborative Communication group will be given recommendations for how to conduct weekly meetings in a collaborative approach based on a modified version of the Minute Meeting protocol.
Pet Fish with Integrated Diabetes Care Only
Participants in the Pet Fish with Integrated Diabetes Care Only Group will be provided specific instructions for coupling the fish care and diabetes care throughout the 12-week intervention.
Routine Pet Fish Care
Participants in the Routine Group will be provided specific instructions for coupling the daily and weekly fish care and diabetes care throughout the 12-week intervention They will also be told to monitor BG four times daily, review BG readings with their parent weekly and document the BG checks and weekly reviews on their device's software.
Control
Participants in the Control Group will be told to monitor BG (blood glucose) four times daily, review BG readings with their parent weekly and document on their device's software.
No interventions assigned to this group
Interventions
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Routine Pet Fish Care
Participants in the Routine Group will be provided specific instructions for coupling the daily and weekly fish care and diabetes care throughout the 12-week intervention They will also be told to monitor BG four times daily, review BG readings with their parent weekly and document the BG checks and weekly reviews on their device's software.
Collaborative Communication
Parents and participants in the Collaborative Communication group will be given recommendations for how to conduct weekly meetings in a collaborative approach based on a modified version of the Minute Meeting protocol.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of T1DM for at least one year
* fluency in English or Spanish, (d) recent HbA1c value 7.5% - 14%
* utilization of a CGM or glucometer that links with software to enable viewing and documentation in daily report including a section to enter "notes" (i.e. CGM/software, Dexcom/Clarity; Freestyle Libre/LibreView; AccuChek,OneTouch (glucometers)/MySugr)
* current pet fish at home or willingness to obtain a pet fish if randomized to that intervention.
Exclusion Criteria
* involvement in foster care
* dual-home living situation
* severe psychiatric disorders
* developmental delay or cognitive impairment that make it difficult to establish consistent diabetes and pet care behaviors
* current participation in another study that may impact glycemic control
* HbA1c \>14% (because these individuals may need a more intensive intervention than this is intended to provide)
* lack of a computer or compatible cell phone for uploading CGM or glucometer data.
10 Years
13 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Olga Gupta
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00115936
Identifier Type: -
Identifier Source: org_study_id
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