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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Indiana University | OTHER |
| University of South Florida | OTHER |
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The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Developmental Demands | Experimental | Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving. |
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| Distress Reduction | Experimental | Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support. |
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| Remote Monitoring | Experimental | Optimize the use of remote monitoring by focusing on situational demands and problem solving. |
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| Fear of Hypoglycemia | Experimental | Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control. |
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| No Intervention | Placebo Comparator | Serves as the control group comparator. No intervention provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Developmental Demands | Behavioral | Education and training related to use of CGM in this age group |
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| Measure | Description | Time Frame |
|---|---|---|
| Time spent in blood glucose range | Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. | Change over 6 months |
| Pediatric Quality of Life Inventory | This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. | Change over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| A1c | The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample. | Change over 6 months |
| Problem Areas in Diabetes |
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To be eligible for the study, a child must meet the following criteria:
To be eligible for the study, a parent must meet the following criteria:
The presence of any of the following is an exclusion for the study:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Kimberly Driscoll, PhD | University of Colorado, Denver | Principal Investigator |
| Linda DiMeglio, MD | Indiana University | Principal Investigator |
| Henry Rodriguez, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University of Colorado |
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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 |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Distress Reduction | Behavioral | Education and training on reducing distress |
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| Remote Monitoring | Behavioral | Education and training on the use of remote monitoring |
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| Fear of Hypoglycemia | Behavioral | Education and training on reducing fear of hypoglycemia |
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| No intervention | Behavioral | No intervention - serves as the control group |
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This measure captures areas that are reported as problems for people with diabetes. Participants in the study report on daily problems with diabetes via this measure.
| Change over 6 months |
| Diabetes Distress Scale | This measure is widely used to capture the psychological distress experienced in relation to diabetes. | Change over 6 months |
| Patient Health Questionnaire 9 | This is a widely used measure that captures depressive symptoms. It is reported by the participants. | Change over 6 months |
| State-Trait Anxiety Inventory | This is a widely used measure of anxiety symptoms. It is reported by the participant. | Change over 6 months |
| Pittsburgh Sleep Quality Index | This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants. | Change over 6 months |
| Hypoglycemic Fear Survey | People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants. | Change over 6 months |
| Hypoglycemic Confidence Questionnaire | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations. | Change over 6 months |
| Glucose Monitoring System Satisfaction Survey | This a measure used to capture overall satisfaction with glucose monitoring devices used by participants. | Change over 6 months |
| General and diabetes-specific technology use | This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. | Change over 6 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of South Florida | Tampa | Florida | 33620 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |