Type 1 Diabetes Mellitis
Conditions
Keywords
type 1 diabetes
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.
Interventions
BEHAVIORALRoutine Pet Fish Care
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.
BEHAVIORALCollaborative Communication
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.
Sponsors
Duke University
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROlga Gupta
Duke University
Outcome results
None listed