This study uses community health workers (CHW) as diabetes technology coaches for African American children using automated insulin delivery systems but have an HbA1c of 8% or higher. Families will meet with the CHW monthly x 6 months with additional visits as needed. All participants and parents/guardians will fill out questionnaires at the beginning and end of the 6 month intervention in addition to an interview at 6 months. This will be followed by 6 months with no extra help from the CHW, but we will continue to follow CGM and pump download data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
16
Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGChange in capillary HbA1c
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in number of participants who use an automated insulin delivery system with at least 80% time in automated mode over the past 30 days, as measured by download of data from the automated insulin delivery system
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring
Time in range (70-180 mg/dL) will be assessed over the 30 day increment prior to each study visit
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time under 70 mg/dL as measured by continuous glucose monitoring
Time under 70 mg/dL will be assessed over the 30 day time increment prior to each study visit
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time over 250 mg/dL as measured by continuous glucose monitoring
Time above 250 mg/dL will be assessed over the 30 day increment prior to each study visit
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in continuous glucose monitor wear time as measured by continuous glucose monitoring
Wear time will be assessed over the 30 day increment prior to each study visit
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time in automated mode as measured by automated insulin delivery system
Time in automated mode will be assessed over the 30 day increment prior to each study visit.
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians
Description: 25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly
Time frame: Baseline, 6 months
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: Baseline, 6 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: Baseline, 6 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: Baseline, 6 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, 6 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, 6 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, 6 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, 6 months
Change in barriers to technology as measured by Barriers to Technology Checklist
19-item yes/no questionnaire
Time frame: Baseline, 6 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: Baseline, 6 months
Change in 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: Baseline, 6 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.