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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07422532
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 years and older
2. Participant has insulin-treated type 2 diabetes on more than 1 insulin injection per day or insulin pump therapy
3. Participant has ESKD and is established on out-patient hospital-based haemodialysis treatment at least 3 times a week, via an arterio-venous fistula, graft or central venous catheter
4. If the participant uses a CGM, the baseline time spent between 3.9 to 10 mmol/L in the last 4 weeks is \<70%
5. For those not using CGM screening HbA1c \>7.0% (53 mmol/mol) and ≤ 12% (108 mmol/mol)
6. Total daily dose of insulin is \> 10 units and \<200 units per day
7. Literate in English for safe study conduct.
8. Willing to wear study glucose sensors and the AID system
9. Willing to follow study-specific instructions
10. Female participants of childbearing age should be on effective contraception, not sexually active / or have no plans for pregnancy
11. All patients whether transplant-wait listed or not, are eligible for inclusion.
Exclusion Criteria:
Exclusion Criteria
1. Any other physical disease or people with known severe mental illness (psychotic disorder, bipolar disorder, dementia, substance and alcohol dependence, learning disabilities, active suicidal ideation) that are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
2. Either current use of peritoneal dialysis or planned modality transfer (transplantation from a live donor with a confirmed date, peritoneal dialysis or conservative care) in the next 18 weeks
3. Only treated with background (basal) insulin
4. The participant is currently on AID or more than 2 weeks use of AID in the last 4 weeks
5. Known or suspected allergy against insulin
6. Treated with sulphonylureas (use of SGLT2 inhibitors are allowed)
7. Treated with hydroxyurea (sensor interference)
8. Presence of unstable retinopathy per Investigator's judgement
9. Severe bilateral visual impairment
10. Pregnancy, planned pregnancy in the next 3 months or breastfeeding current or planned glucocorticoid use other than inhaled/ topical use. Stable long-term steroid use is not an exclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07422532
Study Brief:
Protocol Section:
NCT07422532