Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

Not Applicable

• Conditions: Type 1 Diabetes Mellitis
• Interventions: Behavioral: Routine Pet Fish Care; Behavioral: Collaborative Communication

• Registration Number: NCT06598345
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Status Verified: 2025-04
• Study Start: 2025-04-16
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pet Fish with Integrated Diabetes Care + Collaborative Communication	Routine Pet Fish Care	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.
Pet Fish with Integrated Diabetes Care + Collaborative Communication	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.
Pet Fish with Integrated Diabetes Care Only	Routine Pet Fish Care	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.

Primary Outcome Measures

Name	Time	Method
Recruitment rate	Baseline	Recruitment rate will be calculated as \[number of participants assenting\] divided by \[number who were invited\]
Fidelity to BGM (blood glucose monitoring) partnered with fish feeding	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.
Fidelity to weekly reviews partnered with fish tank maintenance	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.
Retention rate	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 Outcome Measures

Name	Time	Method
Number of blood glucose (BG) readings receiving parental review	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.
Time in Range (TIR)	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.
Self Care Inventory (SCI) (modified)	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".
Blood glucose monitoring (BGM) frequency	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.
HbA1c (Hemoglobin A1C) level	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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States