Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
NCT ID:
NCT05756361
Eligibility Criteria:
Inclusion Criteria:
* T1D of 12 or more months duration
* Age 6-17-years
* Presence of overweight/obesity
* Youth uses a pump for insulin delivery and a continuous glucose monitoring device to monitor glycemic levels
* Youth has one parent with overweight/obesity willing to participate in the program
Exclusion Criteria:
* Child:
* Chronic conditions other than T1D
* Other autoimmune conditions other then T1D or autoimmune thyroiditis.
* Medications that can affects weight, such as medications used to treat Attention Deficit Disorder or high dose steroids used to treat asthma.
* Depression symptoms by standard of care Patient Health Questionnaire (PHQ) 9 in the child or parent
* Inability to perform at least mild physical activity such as walking
* Child with handicap (such as developmental delay or deafness) that would prevent him/her from benefitting from counseling in person and/or remotely Participating parent with
* symptoms of depression assessed by standard of care PHQ
* autoimmune disorders other than T1D or autoimmune thyroiditis
* Participating parents with chronic disorder that is treated with medications that interfere with weight loss or are preventing him/her from performing at least mild physical activity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT05756361
Study Brief:
Protocol Section:
NCT05756361