Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility

Duke University

Status: Invitation-only

Conditions: Type 1 Diabetes Mellitis

Treatments: Behavioral: Routine Pet Fish Care; Behavioral: Collaborative Communication

Study type: Interventional

Funder types: Other

Identifiers

NCT06598345

Pro00115936

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Pet Fish with Integrated Diabetes Care + Collaborative Communication

Experimental group

Description:

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.

Treatment:

Behavioral: Collaborative Communication

Behavioral: Routine Pet Fish Care

Pet Fish with Integrated Diabetes Care Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Routine Pet Fish Care

Control

No Intervention group

Description:

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.