Type 1 Diabetes (T1D)
Conditions
Keywords
Automated insulin delivery, Community Health Worker, Disparities, Type 1 Diabetes
Brief summary
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.
Interventions
OTHERCommunity Health Worker
Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Single arm pilot intervention study with use of historic controls
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Self-reported as non-Hispanic Black * Clinical diagnosis of type 1 diabetes, requiring treatment with insulin at the time of consent * Currently using, or have used within the past 3 months, an automated insulin delivery system (consisting of a continuous glucose monitor and an insulin pump as well as an automated insulin delivery algorithm) * Clinical care provided at UH Cleveland Medical Center * Has not previously worked with a community health worker for help with diabetes technology
Exclusion criteria
* Clinical diagnosis of Type 2 or monogenic diabetes * Completed high school * At least 1 parent/guardian or family support person not willing to participate * Non-English speaking guardians * Has not used automated insulin delivery within the past 3 months * Has previously worked with a CHW for help with diabetes technology * Custody of children and family services
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Baseline, 3 months, 6 months, 9 months, 12 months |
| Change in capillary HbA1c | Baseline, 3 months, 6 months, 9 months, 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring | Baseline, 3 months, 6 months, 9 months, 12 months | Time in range (70-180 mg/dL) will be assessed over the 30 day increment prior to each study visit |
| Change in time under 70 mg/dL as measured by continuous glucose monitoring | Baseline, 3 months, 6 months, 9 months, 12 months | Time under 70 mg/dL will be assessed over the 30 day time increment prior to each study visit |
| Change in time over 250 mg/dL as measured by continuous glucose monitoring | Baseline, 3 months, 6 months, 9 months, 12 months | Time above 250 mg/dL will be assessed over the 30 day increment prior to each study visit |
| Change in continuous glucose monitor wear time as measured by continuous glucose monitoring | Baseline, 3 months, 6 months, 9 months, 12 months | Wear time will be assessed over the 30 day increment prior to each study visit |
| Change in time in automated mode as measured by automated insulin delivery system | Baseline, 3 months, 6 months, 9 months, 12 months | Time in automated mode will be assessed over the 30 day increment prior to each study visit. |
| Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians | Baseline, 6 months | Description: 25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly |
| Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale | Baseline, 6 months | 19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always |
| Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy | Baseline, 6 months | 28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem |
| Change in medical distrust, as measured by the Group Based Medical Distrust Scale | Baseline, 6 months | 12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree |
| Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index | Baseline, 6 months | 7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime |
| Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index | Baseline, 6 months | 4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree |
| Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale | Baseline, 6 months | 5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree |
| Change in barriers to technology as measured by Barriers to Technology Checklist | Baseline, 6 months | 19-item yes/no questionnaire |
| Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version | Baseline, 6 months | 10-item questionnaire using 6-point Likert scale, where 1 is very sure I can't and 6 is very sure I can |
| Episodes of Diabetic Ketoacidosis as measured by chart review | up to 12 months | 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. |
| Episodes of severe hypoglycemia as measured by chart review | Up to 12 months | Unconscious or having a seizure due to hypoglycemia |
| Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version | Baseline, 6 months | 18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree |
| Change in Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale | Baseline, 6 months | 16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree |
Other
| Measure | Time frame |
|---|---|
| Number of meetings with community health worker | Up to 6 months |
| Duration in hours/minutes of meetings with community health worker | Up to 6 months |
Countries
United States
Contacts
Primary ContactWendy Campbell, RN, CDCES
Backup ContactJulie Hutter, RN
Outcome results
None listed