Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes

NCT02432586 | Completed

• 1 other identifier: STU 042014-061
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

T1DM; Diabetes; Child; Toddler

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (13)

• Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 1

  One month pre-camp, one month post-camp

• Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 2

  One month pre-camp, one month post-camp

• Medical system utilization ( emergency room visits, hospitalizations related to T1DM)

  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

  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

  One month pre-camp, one month post-camp

Study Arms (1)

Intensive Education

OTHER

Attendance of 2 intensive education sessions

Behavioral: Intensive Education

Interventions

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.

Intensive Education

Eligibility Criteria

• Age: 34 Months - 68 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-5.5 years old (+/- 2 months) at the date of first camp session they are eligible to join.
• Child and Parents fluent in either English or Spanish.
• 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 MODY; 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 we 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 TSH 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Perrin White, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: May 4, 2015
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share