Clinical trial NCT06074458: GO TEAM: Glucose Optimization Through Technology Assisted Management
Official title: GO TEAM INTERVENTION PROTOCOL: GLUCOSE OPTIMIZATION THROUGH TECHNOLOGY ASSISTED MANAGEMENT: Use of a Diabetes Dashboard and Community Health Worker to Decrease Disparities in Technology Use in Pediatric T1D
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Pediatric
Diabetes Technology
Disparities
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: KeborMed
First posted: 2023-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Black/African American children and young adults with type 1 diabetes are less likely to use diabetes technologies, such as continuous glucose monitors, insulin pumps, and automated insulin delivery systems, compared to White children and young adults. The investigators are working to find ways to make sure that all patients with type 1 diabetes are equally able to use these technologies. The purpose of this study is to find out if a new computer program for the diabetes team, along with a smartphone app (called Glucosano) for patients/parents, as well as a community health worker, are accepted and used by Black/African American patients and parents living with type 1 diabetes, and if this can help decrease racial disparities in the use of diabetes technologies.


Eligibility criteria: Inclusion Criteria:

* Self-reported as Non-Hispanic Black
* Clinical diagnosis of T1D requiring treatment with insulin at the time of consent
* Not currently (within the past 3 months) using an automated insulin delivery system \\
* Willingness to wear a continuous glucose monitor for 10 days at 3 different time points, and willingness to consider use of a personal continuous glucose monitor

Exclusion Criteria:

* Clinical diagnosis of Type 2 or monogenic diabetes
* Completed high school
* Non-English speaking guardians
* Automated insulin delivery system use within the past 3 months
* Custody of children and family services

Primary outcomes:
measure: Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
timeFrame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in percentage of participants who remain on AID as measured by medical record review
timeFrame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)
timeFrame: 3 months and 12 months
measure: Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)
timeFrame: 3 months and 12 months
measure: Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)
timeFrame: 3 months and 12 months
measure: Number of times patient reached out to team as measured by medical record review
timeFrame: Up to 12 months
measure: Number of automatically generated alerts as measured by dashboard/app review
timeFrame: Up to 12 months
measure: Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review
timeFrame: Up to 12 months
measure: Number of alerts as measured by dashboard review
timeFrame: Up to 12 months
measure: Number of phone calls initiated by patients as measured by dashboard review
timeFrame: Up to 12 months
measure: Number of downloads of the app
timeFrame: Up to 12 months
measure: Number of days of patient/family use interaction with the app as measured by dashboard review
timeFrame: Up to 12 months
measure: Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data
timeFrame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in percentage of CGM wear time as measured by CGM data
timeFrame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in percentage of participants using an insulin pump as measured by chart review
timeFrame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
measure: Change in capillary HbA1c
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in time in range as measured by continuous glucose monitoring
timeFrame: 4 weeks, 6 months, 12 months
measure: Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring
timeFrame: 4 weeks, 6 months, 12 months
measure: Change in time glucose >250 mg/dL as measured by continuous glucose monitoring
timeFrame: 4 weeks, 6 months, 12 months
measure: Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents
timeFrame: Baseline
measure: Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale
timeFrame: 4 weeks, 12 months
measure: Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy
timeFrame: 4 weeks, 12 months
measure: Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version
timeFrame: 4 weeks, 12 months
measure: Change in medical distrust, as measured by the Group Based Medical Distrust Scale
timeFrame: Baseline, 12 months
measure: Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index
timeFrame: Baseline, 12 months
measure: Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index
timeFrame: Baseline, 12 months
measure: Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale
timeFrame: Baseline, 12 months
measure: Change in barriers to technology as measured by Barriers to Technology Checklist
timeFrame: Baseline, 12 months
measure: CGM satisfaction as measured by the CGM satisfaction scale
timeFrame: 12 months
measure: Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version
timeFrame: 4 weeks, 12 months
measure: Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale
timeFrame: 12 months
measure: Episodes of Diabetic Ketoacidosis as measured by chart review
timeFrame: up to 12 months
measure: Episodes of severe hypoglycemia as measured by chart review
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References: