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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Indiana University | OTHER |
| Yale University | OTHER |
| University of South Florida |
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This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Developmental & Technological 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. Identify and troubleshoot barriers to keeping young children in Auto Mode. |
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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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| Nutrition, Set Point, & C:I Ratio | Experimental | Provide education on a variety of properties of food and how they affect blood glucose levels. Optimize the use of carbohydrate to Insulin ratios, insulin duration of action, and use of temporary target glucose set point in the 670G pump and the Quick bolus feature to gain better glycemic control. |
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| Hypoglycemia management | Experimental | Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia |
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| Minimal Intervention | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Developmental & Technological 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 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin 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 3 months |
| Problem Areas in Diabetes |
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To be eligible for the study, a child must meet the following criteria since enrollment in the CEP 302 Trial:
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 (since enrollment in the CEP 302 Trial):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2017 | Nov 3, 2017 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D048788 | Growth and Development |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D010829 | Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D006304 | Health Status |
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| OTHER |
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A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
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| Distress Reduction | Behavioral | Education and training on reducing distress |
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| Nutrition, Set Point, & C:I Ratio | Behavioral | Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control |
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| Hypoglycemia management | Behavioral | Education and training on reducing worries of hypoglycemia |
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| Minimal Intervention | Behavioral | Minimal intervention to simulate standard care - 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 3 months |
| Parent Diabetes Distress Scale | This measure is widely used to capture the psychological distress experienced in relation to diabetes. | Change over 3 months |
| Patient Health Questionnaire 8 | This is a widely used measure that captures depressive symptoms. It is reported by the participants. | Change over 3 months |
| State-Trait Anxiety Inventory | This is a widely used measure of anxiety symptoms. It is reported by the participant. | Change over 3 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 3 months |
| Hypoglycemic Fear Survey - Parents | People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants. | Change over 3 months |
| Hypoglycemia Confidence Questionnaire | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations. | Change over 3 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 3 months |
| Glucose Monitoring System Satisfaction Survey | This a measure used to capture overall satisfaction with glucose monitoring devices used by participants. | Change over 3 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 3 months |
| Diabetes management behaviors | Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads. | Change over 3 months |
| Health care utilization | Number of visits and calls to the diabetes care team. | Change over 3 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003710 | Demography |
| D011154 | Population Characteristics |