Camp Based Multi-component Intervention for Families of Young Children With Type 1 Diabetes

Stopped early · Not applicable

Conditions studied: Type1diabetes

In brief

Eighteen 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.

Key facts

Study ID

NCT04279587

Run by

University of Texas Southwestern Medical Center

People needed

3

Starts

2019-08-19

Expected to finish

2023-02-13

Last updated by the study team

2024-08-26

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 3-5.5 years old (+/- 2 months) at the date of camp session they are eligible to join.
• Child and Parents fluent in English
• Type 1 diabetes mellitus diagnosed for at least 10 months previous to date of first camp they are eligible to join.
• Taking insulin
• Custodial parent or guardian (preferable both parents or guardians) willing to attend both session of camp and the activities scheduled for them.
• Parent or guardian must sign consent before any study procedures are performed.

You may not qualify if…

• Neonatal diabetes (diagnosis in the first 3 months of life) or documented Monogenic Diabetes of Youth; i.e., a likely genetic form of diabetes rather than an autoimmune etiology.
• Post-surgical diabetes (e.g., pancreatectomy for congenital hyperinsulinism). Such patients often cannot secrete glucagon, leading to a particularly severe inability to defend against hypoglycemia.
• Other severe chronic disease (e.g., cancer, cystic fibrosis) which in the judgment of the investigator is likely to significantly affect glycemic control.
• Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but the investigators will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
• Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and thyroid stimulating hormone within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
• Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with group activities.
• Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with group activities.
• Celiac disease is not an exclusion criterion.

Where it is running

• Perrin C White — Dallas, Texas, United States
• Children's Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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