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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application
Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGChange in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
Time frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of participants who remain on AID as measured by medical record review
Time frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)
4 item measure of acceptability using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Time frame: 3 months and 12 months
Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)
4 item measure of feasibility using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Time frame: 3 months and 12 months
Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)
4 item measure of appropriateness using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
Time frame: 3 months and 12 months
Number of times patient reached out to team as measured by medical record review
Time frame: Up to 12 months
Number of automatically generated alerts as measured by dashboard/app review
Time frame: Up to 12 months
Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review
Time frame: Up to 12 months
Number of alerts as measured by dashboard review
Time frame: Up to 12 months
Number of phone calls initiated by patients as measured by dashboard review
Time frame: Up to 12 months
Number of downloads of the app
Time frame: Up to 12 months
Number of days of patient/family use interaction with the app as measured by dashboard review
Time frame: Up to 12 months
Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data
Time frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of CGM wear time as measured by CGM data
Time frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of participants using an insulin pump as measured by chart review
Time frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in capillary HbA1c
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time in range as measured by continuous glucose monitoring
Time in range is time glucose is between 70-180 mg/dL
Time frame: 4 weeks, 6 months, 12 months
Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring
Time frame: 4 weeks, 6 months, 12 months
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring
Time frame: 4 weeks, 6 months, 12 months
Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents
25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly true
Time frame: Baseline
Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale
19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always
Time frame: 4 weeks, 12 months
Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy
28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem
Time frame: 4 weeks, 12 months
Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version
18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree
Time frame: 4 weeks, 12 months
Change in medical distrust, as measured by the Group Based Medical Distrust Scale
12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time frame: Baseline, 12 months
Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index
7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime
Time frame: Baseline, 12 months
Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index
4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree
Time frame: Baseline, 12 months
Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale
5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time frame: Baseline, 12 months
Change in barriers to technology as measured by Barriers to Technology Checklist
19-item yes/no questionnaire
Time frame: Baseline, 12 months
CGM satisfaction as measured by the CGM satisfaction scale
37-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time frame: 12 months
Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version
10-item questionnaire using 6-point Likert scale, where 1 is "very sure I can't" and 6 is "very sure I can"
Time frame: 4 weeks, 12 months
Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale
16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Time frame: 12 months
Episodes of Diabetic Ketoacidosis as measured by chart review
DKA defined as presence of all of the following: 1) blood glucose greater than 250 mg/dL, 2) pH less than 7.3 OR bicarbonate less 15 mEq/L, 3)Moderate or large ketones in urine OR blood ketone \>3 mmol/L, 4) Requiring treatment within a health care facility.
Time frame: up to 12 months
Episodes of severe hypoglycemia as measured by chart review
Unconscious or having a seizure due to hypoglycemia
Time frame: up to 12 months
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