Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

NCT06598345 | Enrolling By Invitation DMC

• 1 other identifier: Pro00115936
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes Mellitis

Keywords

type 1 diabetes

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Recruitment rate will be calculated as \[number of participants assenting\] divided by \[number who were invited\]

  Baseline

• Fidelity to BGM (blood glucose monitoring) partnered with fish feeding

  Fidelity to BGM partnered with fish feeding will be assessed by calculating the percentage of BG checks that were partnered with fish feeding.

  3 months

• Fidelity to weekly reviews partnered with fish tank maintenance

  Fidelity to weekly reviews partnered with fish tank maintenance will be assessed by calculating the percentage of BG (blood glucose) reviews that were partnered with tank maintenance. The research team will review the data uploads on a weekly basis.

  3 months

• Retention rate

  Retention rate will be calculated as \[number of participants who continue fish care tasks\] divided by \[number who were eligible upon completion of the baseline assessment\].

  3 months

Secondary Outcomes (5)

• Number of blood glucose (BG) readings receiving parental review

  Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)

• Time in Range (TIR)

  Baseline, 3 months, 6 months

• Self Care Inventory (SCI) (modified)

  Baseline, 3 months, 6 months

• Blood glucose monitoring (BGM) frequency

  Baseline, 3 months, 6 months

• HbA1c (Hemoglobin A1C) level

  Baseline, 3 months, 6 months

Study Arms (3)

Pet Fish with Integrated Diabetes Care + Collaborative Communication

EXPERIMENTAL

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.

Behavioral: Routine Pet Fish Care; Behavioral: Collaborative Communication

Pet Fish with Integrated Diabetes Care Only

ACTIVE COMPARATOR

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.

Behavioral: Routine Pet Fish Care

Control

NO INTERVENTION

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.

Interventions

Routine Pet Fish Care BEHAVIORAL

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.

Pet Fish with Integrated Diabetes Care + Collaborative Communication; Pet Fish with Integrated Diabetes Care Only

Collaborative Communication BEHAVIORAL

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 + Collaborative Communication

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Olga Gupta

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)