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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT02530450
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of diabetes for at least 6 months, type 1 or type 2 diabetes.
2. Treated at UT Health Science Center pediatric diabetes clinic for at least the previous 3 months.
3. HgbA1c \>8.5% (equivalent to average BG of \>205 mg/dL for past three months).
4. Supportive family with willingness to self monitoring blood glucose values at least 4 times per day during study.
5. Supportive family with willingness to participate in continuous glucose monitoring (CGM) for at least 48 hours including self monitoring blood glucose values at least 4 times per day, documenting meals, carbohydrates eaten, insulin dose given, exercise, and hypoglycemic symptoms.
6. Attend proposed clinic, nutritional, and CGM follow up visits.
7. Pump or multiple daily injection (MDI) insulin therapy (3-4 injections minimum daily). If on pump, on pump for at least the past 3 months. Current insulin regimen involves basal/ bolus therapy with no plans to switch the modality of insulin administration during the study (e.g., injection user switching to a pump, pump user switching to injections).
8. Hypoglycemic unawareness.
9. English or Spanish primary language.
Exclusion Criteria:
1. Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
2. Documented concomitant chronic disease known to affect glycemic control.
3. 3 or more incidents in the last 12 months of severe hypoglycemia with documented blood glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalization or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
4. 3 or more incidents in the last 12 months of diabetic ketoacidosis (DKA).
5. Reported alcohol or drug abuse.
6. Documented cutaneous allergy to latex products.
7. Documented eating disorders or morbid obesity as assessed by the investigator.
8. Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
9. Home use of CGM in the past 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT02530450
Study Brief:
Protocol Section:
NCT02530450