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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM144270 | U.S. NIH Grant/Contract | View source | |
| 5438 | Other Identifier | NIGMS Sub-Project ID |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM).
Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM.
The other group will be in our Type 1 Together program for 6 months. This will include:
The main questions the study aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 Together | Experimental | In Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker. |
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| Standard of Care | Active Comparator | Quarterly clinic visits with endocrinology provider. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Behavioral | Quarterly clinic visits with endocrinology provider. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Acceptability | How acceptable youth and caregivers find Type 1 Together. This information will be collected only from participants in the experimental arm using the Acceptability of Intervention Measure (scores range 1-5 with higher scores indicating greater acceptability). | 6 months post-enrollment |
| Perceptions of continuous glucose monitoring systems | Youth perceptions of the benefits and burdens of using continuous glucose monitoring systems will be assessed using the CGM Benefits and Burdens Scales (scores range 1-5 with higher scores indicating greater perceived benefits or burdens). | Baseline and 3, 6, 9, and 12 months post-enrollment. |
| Continuous Glucose Monitoring System Use | The number of days a patient wore their continuous glucose monitoring system at least 12 hours over the past month. | Baseline and 3, 6, 9, and 12 months post-enrollment |
| HbA1c | HbA1c expressed as a percentage of glycosylated hemoglobin | Baseline and 3, 6, 9, and 12 months post-enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Hospital, Delaware | Wilmington | Delaware | 19803 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Type 1 Together |
| Behavioral |
In Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |