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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT06330194
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent obtained before any trial-related procedures are performed
2. Type 1 diabetes of at least 1-year duration or insulin requiring type 2 diabetes (Total insulin dose should be below 200 IE per day)
3. Maintenance HD, PD, or CKD stage 3b-5 (not on dialysis).
4. Subject must be willing and able to comply with trial protocol
5. HbA1c \<91 mmol/mol (10.5%)
All participants will require to have internet or mobile phone access enabling upload of the AID system data to cloud based software.
Exclusion Criteria:
1. History of ketoacidosis within the past 6 months
2. Moderate to severe cognitive impairment
3. Major allergy to tape/ adhesives
4. Women who are pregnant or planning pregnancy
5. Life-expectancy to \<6 months
6. Major psychiatric history
7. Treatment with sulphonylureas in pre-dialysis participants (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines)
8. Treatment with non-insulin glucose lowering therapies may not be used on dialysis participants (with the exception of GLP1 agonists used in preparation for transplantation)
9. Systemic steroid treatment within 4 weeks (stable doses of steroids \>8 weeks allowed)
10. Visual impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06330194
Study Brief:
Protocol Section:
NCT06330194