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:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT02199028
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months
2. Total daily insulin dose of at least 0.4 units/kg/day
3. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
4. Age 12 to 45 years
5. Hemoglobin A1c level less than or equal to 10%
6. Willingness to infuse 1 ml of hyaluronidase (Hylenex) into the insulin infusion set after insertion on day 1 and day 3 of the week they are assigned to use hyaluronidase
7. Willingness to use a Silhouette or Comfort insulin infusion set throughout the study. The set includes the Duo Infusion Tubing for infusion of hyaluronidase (Hylenex).
8. Willingness to eat the same breakfast each morning for the first two weeks of the study
9. Willing to take two 500mg tablets of Tylenol Regular Strength and monitor glucose levels at ½, 1, 2, 4, 6, and 8 hours later.
10. For females, not currently known to be pregnant
11. An understanding of and willingness to follow the protocol and sign the informed consent
12. Must be able to understand spoken or written English
Exclusion Criteria:
1. Diabetic ketoacidosis in the past 6 months
2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
3. Known tape allergies
4. Current treatment for a seizure disorder
5. Cystic fibrosis
6. Active infection
7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
8. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
9. Presence of a known adrenal disorder
10. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
11. Abuse of alcohol
12. Use of an OmniPod insulin infusion pump
13. Pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
45 Years
Study:
NCT02199028
Study Brief:
Protocol Section:
NCT02199028