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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pet Fish with Integrated Diabetes Care + Collaborative Communication | Experimental | 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. |
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| Pet Fish with Integrated Diabetes Care Only | Active Comparator | 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. |
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| Control | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment rate will be calculated as [number of participants assenting] divided by [number who were invited] | 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. | 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. | 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]. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, during intervention and post-intervention (monthly intervals, up to 6 months) |
| Time in Range (TIR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Gupta | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
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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. |
| Baseline, 3 months, 6 months |
| 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". | 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. | 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. | Baseline, 3 months, 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |