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

Not Applicable

Terminated

• Conditions: Type1diabetes

• Registration Number: NCT04279587
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-2-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Inclusion Criteria:<br><br> - Age 3-5.5 years old (+/- 2 months) at the date of camp session they are eligible to<br> join.<br><br> - Child and Parents fluent in English<br><br> - Type 1 diabetes mellitus diagnosed for at least 10 months previous to date of first<br> camp they are eligible to join.<br><br> - Taking insulin<br><br> - Custodial parent or guardian (preferable both parents or guardians) willing to<br> attend both session of camp and the activities scheduled for them.<br><br> - Parent or guardian must sign consent before any study procedures are performed.<br><br>Exclusion Criteria:<br><br> - Neonatal diabetes (diagnosis in the first 3 months of life) or documented Monogenic<br> Diabetes of Youth; i.e., a likely genetic form of diabetes rather than an autoimmune<br> etiology.<br><br> - Post-surgical diabetes (e.g., pancreatectomy for congenital hyperinsulinism). Such<br> patients often cannot secrete glucagon, leading to a particularly severe inability<br> to defend against hypoglycemia.<br><br> - Other severe chronic disease (e.g., cancer, cystic fibrosis) which in the judgment<br> of the investigator is likely to significantly affect glycemic control.<br><br> - Patients cannot be taking systemic corticosteroids at enrollment because of adverse<br> effects on glycemic control, but the investigators will not disqualify subjects who<br> require such therapy during the study. Inhaled or topical corticosteroids are<br> permissible.<br><br> - Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and<br> have free T4 and thyroid stimulating hormone within age-appropriate reference ranges<br> at last medically indicated testing. Patients with out of range values may be<br> retested after medication dose adjustment.<br><br> - Developmental delay or behavioral disorder in the patient of sufficient severity, in<br> the judgment of the investigator, to interfere with group activities.<br><br> - Medical or psychiatric disorder in a parent of sufficient severity, in the judgment<br> of the investigator, to interfere with group activities.<br><br> - Celiac disease is not an exclusion criterion.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Change in PedsQL Family Impact Module;Change in PedsQL Pediatric Quality of Life Inventory;Change in Hypoglycemia Fear Survey;Change in Behavioral Pediatrics Feeding Assessment