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Behavioral Intervention
Pet Care + Communication Training for Type 1 Diabetes
N/A
Waitlist Available
Led By Olga Gupta
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 10-13 years (inclusive)
Be younger than 18 years old
Must not have
Clinical or laboratory characteristics suggestive of type 2 DM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if taking care of a pet fish, along with communication skills training, can help improve blood sugar control in young teenagers with type 1 diabetes.
Who is the study for?
This trial is for early adolescents with type 1 diabetes who struggle to keep their blood sugar levels under control. Participants should be interested in taking care of a pet fish and willing to learn new communication skills as part of their diabetes management routine.
What is being tested?
The study tests if adding the responsibility of caring for a pet fish and improving family communication helps young people manage their type 1 diabetes better, by looking at how often they check and control their blood sugar levels.
What are the potential side effects?
There are no direct medical side effects expected from this trial since it involves non-medical interventions like pet care and communication training. However, participants may experience changes in daily routines or stress related to new responsibilities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 13 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I show signs of having type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fidelity to BGM (blood glucose monitoring) partnered with fish feeding
Fidelity to weekly reviews partnered with fish tank maintenance
Recruitment rate
+1 moreSecondary study objectives
Blood glucose monitoring (BGM) frequency
HbA1c (Hemoglobin A1C) level
Number of blood glucose (BG) readings receiving parental review
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Pet Fish with Integrated Diabetes Care + Collaborative CommunicationExperimental Treatment2 Interventions
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 II: ControlActive Control1 Intervention
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 III: Pet Fish with Integrated Diabetes Care OnlyActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,459 Previous Clinical Trials
2,969,353 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,565 Previous Clinical Trials
4,301,661 Total Patients Enrolled
Olga GuptaPrincipal InvestigatorDuke University