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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
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The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.
Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.
Adolescents face many challenges as they transition from childhood to adulthood. For adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management.
The goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. Adolescent participants will be assigned to one of 6 groups. Some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. Other participants will be asked to continue their diabetes management as usual.
Researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (low-value incentive, 6 months [24 weeks]) | Experimental | If the participant is assigned to Group A, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $294 over a period of 24 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $66 over a period of 24 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $360 over a period of 24 weeks. |
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| Group B (high-value incentive, 6 months [24 weeks]) | Experimental | If the participant is assigned to Group B, they would receive $3.50 for each day that they meet their diabetes self-management goal. This equates to up to $98 every 4 weeks ($3.50 x 28 days = $98), or up to $588 over a period of 24 weeks. They would also receive $5.50 for each week that they meet their clinical outcome goal. This equates to up to $22 every 4 weeks ($5.50 x 4 weeks), or up to $132 over a period of 24 weeks. In total, they could earn up to $120 ($98 + $22) every 4 weeks, or up to $720 over a period of 24 weeks. |
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| Group C (low-value incentive, 12 months [48 weeks]) | Experimental | If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Incentives Program | Behavioral | Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time In Range | Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL) | Change over 12-18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time Above Range | Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL). | Change over 12-18 months |
| Time Below Range | Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Pihoker, MD | Contact | 206-987-2637 | catherine.pihoker@seattlechildrens.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's | Recruiting | Seattle | Washington | 98105 | United States |
The Harvard Dataverse repository provides searchable study-level metadata for dataset discovery. The repository assigns DOIs as persistent identifiers and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. The dataset will be tagged with the NIH award number to facilitate searches.
Data requests can be submitted at the end of the funding period and the data will be made accessible for up to 10 years.
The Harvard Dataverse repository, is an open-source web application that provides searchable study-level metadata for dataset discovery. The repository assigns DOIs as persistent identifiers and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. The dataset will be tagged with the NIH award number to facilitate searches.
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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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| Group D (high-value incentive, 12 months [48 weeks]) | Experimental | If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks. |
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| Group E (usual care, 6 months [24 weeks]) | No Intervention | Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
| Group F (usual care, 12 months [48 weeks]) | No Intervention | Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
| Change over 12-18 months |
| Hemoglobin A1c (HbA1c) | HbA1c laboratory measurements collected during the intervention. | Change over 12-18 months |
| Diabetes Distress | Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (scale: 14-84). | Change over 12-18 months |
| Diabetes Family Conflict | Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (scale: 19-57). | Change over 12-18 months |
| Adolescent Quality of Life | Adolescent health-related quality of life will be assessed with the EQ-5D instrument. High score indicated higher health status (scale: 0-100). | Change over 12-18 months |
| Caregiver Quality of Life | Caregiver quality of life will be assessed using the Care-related Quality of Life instrument. Higher scores represent higher caregiving burden (score: 0-100). | Change over 12-18 months |
| Diabetic Ketoacidosis | Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data. | 12-18 months |
| Severe Hypoglycemia | Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data. | 12-18 months |
| Insulin Adminstration | Daily bolus insulin administration will be assessed based on data collected on insulin pump or inPen diabetes data management platforms. | Change over 12-18 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |