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18 preschool aged children and their families will attend structured, multidisciplinary, family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children. A second 'booster' session, will be conducted 6 months later.
We propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend, with a second similar "booster" session 6 months later. The intervention will be based at our regional diabetes camp, Camp Sweeney. The proposed camp encounters aim to provide:
We will conduct this pilot study, which will enroll 18 preschool children age 3-5.5 years, with the goal of obtaining preliminary results for 15 subjects.
The primary outcome, to be determined approximately one month before and after each of the two camp sessions, is improvement in Hemoglobin A1c (HbA1c). This outcome will be compared with that of historical controls.
Exploratory Hypotheses:
Compared with pretreatment baseline and historical controls, subjects attending two 3-day sessions at a family diabetes camp will improve:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Education | Other | Attendance of 2 intensive education sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Education | Behavioral | Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at our regional diabetes camp, Camp Sweeney. A second 'booster' session will be conducted 6 months later. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 1 | As compared to historical controls | One month pre-camp, one month post-camp |
| Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 2 | As compared to historical controls | One month pre-camp, one month post-camp |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 1 | As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL. | One month pre-camp, one month post-camp |
| Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perrin White, MD | University of Texas Southwestern Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL. |
| One month pre-camp, one month post-camp |
| Medical system utilization ( emergency room visits, hospitalizations related to T1DM) | Composite measure. As compared to historical controls. | Duration of participation in study, expected to be 10 months |
| Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 1 | Parent report | One month pre-camp, one month post-camp |
| Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 2 | Parent report | One month pre-camp, one month post-camp |
| Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 1 | Parent report for Toddlers, Parent report for Young Children, Young Child Report | One month pre-camp, one month post-camp |
| Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 2 | Parent report for Toddlers, Parent report for Young Children, Young Child Report | One month pre-camp, one month post-camp |
| Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 1 | Parent report for Toddlers, Parent report for Young Children, Young Child Report | One month pre-camp, one month post-camp |
| Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 2 | Parent report for Toddlers, Parent report for Young Children, Young Child Report | One month pre-camp, one month post-camp |
| Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 1 | Parents of young children version | One month pre-camp, one month post-camp |
| Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 2 | Parents of young children version | One month pre-camp, one month post-camp |
| Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 1 | Behavior section | One month pre-camp, one month post-camp |
| Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 2 | Behavior section | One month pre-camp, one month post-camp |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |