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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT05928260
Eligibility Criteria:
Inclusion Criteria:
1. Adolescents and adults aged 15-40 years with Type-1 Diabetes mellitus defined by any of the following; i. Diabetic Ketoacidosis or ketonemia or ketonuria at diagnosis with insulin dependence for survival since diagnosis OR ii. Insulin dependence for survival since diagnosis and any one of the following autoantibody positivity: GAD-65 or IA-2
2. Patients on Basal bolus regimen (Glargine as basal and lispro /Aspart /Glulisine as bolus);
3. Duration of Diabetes \> 2 years;
4. Insulin dose requirement of at least 0.5U/kg
5. HbA1c 8%-12%;
6. Gold score\<4;
7. No previous experience with rt-CGMS and/or is-CGMS;
8. Euthyroid status;
9. If hypothyroid, then on stable dose of Levothyroxine for last 3 months with normal T4 level;
10. Urine albumin creatinine ratio\<300 mg/g of Creatinine;
11. Those willing to give informed consent prior to enrolment.
Exclusion Criteria:
1. LADA or Secondary Diabetes
2. eGFR\<60ml/min/1.73m2
3. Celiac disease;
4. Hb\<12g/dl for males and \<11g/dl for females;
5. Hypoglycemia unawareness defined by Gold scoreā„4;
6. HbA1c\>12%;
7. Diabetic Ketoacidosis in the previous 3 months;
8. Severe Non proliferative Diabetic retinopathy/Proliferative Diabetic Retinopathy/Macular edema;
9. Pregnancy;
10. Lactation;
11. Willing to become pregnant during study;
12. Requiring MRI for any existing condition;
13. Any other chronic illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
40 Years
Study:
NCT05928260
Study Brief:
Protocol Section:
NCT05928260