Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

April 7, 2026 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Active Comparator: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Baseline
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of blood glucose (BG) readings receiving parental review
Time Frame: Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)
Weekly BG review will be determined using the Weekly Review notations on the device's digital platform.
Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)
Time in Range (TIR)
Time Frame: Baseline, 3 months, 6 months
Time in range (TIR) for participants using a continuous glucose monitor will be expressed as percentage of glucose readings between 70-180 mg/dL for the 2 weeks prior to the study visit per the report (i.e. Dexcom Clarity®) which is downloaded in clinic as standard of care.
Baseline, 3 months, 6 months
Self Care Inventory (SCI) (modified)
Time Frame: Baseline, 3 months, 6 months
Three items from this validated measure assessing perceptions of adherence to diabetes self-care recommendations (BGM, BG review, insulin adjustment) over the previous 4 weeks will be used. Responses are on a 5-point Likert scale ranging from 0 = "Never do it" to 4 = "Always do this as recommended without fail".
Baseline, 3 months, 6 months
Blood glucose monitoring (BGM) frequency
Time Frame: Baseline, 3 months, 6 months
Daily BGM frequency will be determined using the BG notations on device's digital platform. The percentage of days on which participants complete four SMBGs (self-monitoring of blood glucose) will be reported.
Baseline, 3 months, 6 months
HbA1c (Hemoglobin A1C) level
Time Frame: Baseline, 3 months, 6 months
HbA1c is a biomarker that provides an estimate of glycemic control over the previous 3 months. HbA1c will be measured using a finger stick blood sample analyzed on a DCA Vantage Analyzer (Siemens). ADA recommends a goal of HbA1c <7% for this early adolescent age group.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olga Gupta, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00115936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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