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Enrolling by invitation NCT06598345

Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

No phase Interventional Type 1 Diabetes Mellitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine Pet Fish Care, Collaborative Communication.
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitis. Basic parameters: 10 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 improve glycemic control, blood glucose monitoring frequency and blood glucose review in early adolescents with suboptimal control of type 1 diabetes.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Recruitment rate [Time frame: Baseline]
  • Fidelity to BGM (blood glucose monitoring) partnered with fish feeding [Time frame: 3 months]
  • Fidelity to weekly reviews partnered with fish tank maintenance [Time frame: 3 months]
  • Retention rate [Time frame: 3 months]
Secondary outcome measures (5)
  • Number of blood glucose (BG) readings receiving parental review [Time frame: Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)]
  • Time in Range (TIR) [Time frame: Baseline, 3 months, 6 months]
  • Self Care Inventory (SCI) (modified) [Time frame: Baseline, 3 months, 6 months]
  • Blood glucose monitoring (BGM) frequency [Time frame: Baseline, 3 months, 6 months]
  • HbA1c (Hemoglobin A1C) level [Time frame: Baseline, 3 months, 6 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke University — Durham

Identifiers

NCT: NCT06598345 · Pro00115936

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗