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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT04904718
Eligibility Criteria:
Inclusion Criteria:
1. Participant with Type 1 diabetes
2. Age ≥ 6 years to \<30 years
3. Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features
1. Insulin pump must not use automated insulin delivery (closed loop, artificial pancreas)
2. Total daily dose of insulin must be greater than 0.5 units/kg/day
4. Participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (Pump, BG meter etc) to Tidepool.
5. Participants using Dexcom sensors will allow access to their account for the study duration
6. Participants not using CGM must agree to test BG at least 4 times a day at appropriate intervals
7. Participants / parents will have to have a smartphone (Apple or Android and Windows)
Exclusion Criteria:
1. An episode of diabetic ketoacidosis within the month prior to study entry
2. Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
3. Current participation in any other interventional study
4. Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
5. Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
6. Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
7. Participants suffers from an eating disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
30 Years
Study:
NCT04904718
Study Brief:
Protocol Section:
NCT04904718