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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
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.
Duke University
Durham, North Carolina, United States
Recruitment rate
Recruitment rate will be calculated as \[number of participants assenting\] divided by \[number who were invited\]
Time frame: Baseline
Fidelity to BGM (blood glucose monitoring) partnered with fish feeding
Fidelity to BGM partnered with fish feeding will be assessed by calculating the percentage of BG checks that were partnered with fish feeding.
Time frame: 3 months
Fidelity to weekly reviews partnered with fish tank maintenance
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.
Time frame: 3 months
Retention rate
Retention rate will be calculated as \[number of participants who continue fish care tasks\] divided by \[number who were eligible upon completion of the baseline assessment\].
Time frame: 3 months
Number of blood glucose (BG) readings receiving parental review
Weekly BG review will be determined using the Weekly Review notations on the device's digital platform.
Time frame: Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)
Time in Range (TIR)
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.
Time frame: Baseline, 3 months, 6 months
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Self Care Inventory (SCI) (modified)
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".
Time frame: Baseline, 3 months, 6 months
Blood glucose monitoring (BGM) frequency
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.
Time frame: Baseline, 3 months, 6 months
HbA1c (Hemoglobin A1C) level
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.
Time frame: Baseline, 3 months, 6 months