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:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT03819634
Eligibility Criteria:
Inclusion Criteria:
Type 1 Diabetes by clinical definition
1. Age 22 and over
2. On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.
3. Hemoglobin A1c level less than or equal to 9%
4. Eating more than 60 grams of carbohydrate each day
5. For females, not currently known to be pregnant
6. Understanding and willingness to follow the protocol and sign informed consent
7. Willingness to wear the experimental infusion sets
8. Willingness to have photographs taken of their infusion sites
9. Ability to speak, read and write in the language of the investigators
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
1. Diabetic ketoacidosis in the past 3 months
2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
3. Pregnant or lactating
4. Known tape allergies
5. Active infection
6. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
7. Known cardiovascular events in the last 6 months
8. Known acute proliferative diabetic retinopathy
9. Known adrenal disorder
10. Current treatment for a seizure disorder
11. Inpatient psychiatric treatment in the past 6 months
12. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
13. Use of SGLT inhibitor
14. Suspected drug or alcohol abuse
15. Dialysis or end stage kidney disease
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03819634
Study Brief:
Protocol Section:
NCT03819634