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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Health Worker | Experimental | Community Health Workers will meet with families monthly in the role of a diabetes technology coach, with additional visits as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker | Other | Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in capillary HbA1c | 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 | Baseline, 3 months, 6 months, 9 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months, 6 months, 9 months, 12 months |
| Change in time under 70 mg/dL as measured by continuous glucose monitoring |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Campbell, RN, CDCES | Contact | 216-844-3661 | wendy.campbell@uhhospitals.org | |
| Julie Hutter, RN | Contact | 216-844-3661 | julie.hutter@uhhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Sarah A MacLeish, DO | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
This is a pilot study
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Single arm pilot intervention study with use of historic controls
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Time under 70 mg/dL will be assessed over the 30 day time increment prior to each study visit |
| 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, 6 months |
| Change in barriers to technology as measured by Barriers to Technology Checklist | 19-item yes/no questionnaire | 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" | 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 | 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. | up to 12 months |
| Episodes of severe hypoglycemia as measured by chart review | Unconscious or having a seizure due to hypoglycemia | Up to 12 months |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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