Status:

ENROLLING_BY_INVITATION

Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

Lead Sponsor:

Duke University

Collaborating Sponsors:

University of North Carolina, Chapel Hill

Conditions:

Type 1 Diabetes Mellitis

Eligibility:

All Genders

10-13 years

Phase:

NA

Brief Summary

The goal of this clinical trial is to learn if incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with communication skills training works to impro...

Eligibility Criteria

Inclusion

  • age 10-13 years (inclusive)
  • 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

  • clinical or laboratory characteristics suggestive of type 2 DM
  • 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.

Key Trial Info

Start Date :

April 16 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06598345

Start Date

April 16 2025

End Date

August 31 2027

Last Update

May 1 2025

Active Locations (1)

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1

Duke University

Durham, North Carolina, United States, 27705