Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

NCT ID: NCT06598345

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Routine Pet Fish Care

Intervention Type 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.

Collaborative Communication

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Routine Pet Fish Care

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olga Gupta

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00115936

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.