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Enrolling by Invitation

NCT Number: NCT06598345

Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

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.

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Key information

Conditions

Type 1 Diabetes Mellitis Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline

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

  2. 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. 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.

  4. 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].

Secondary outcomes

  1. 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.

  2. 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.

  3. 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".

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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