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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT04043260
Eligibility Criteria:
Inclusion Criteria:
1. Documented T1D for at least 1 year prior to study enrolment
2. Subjects aged 18 - 65 years old
3. A1c at inclusion ≤ 10%
4. Subjects using basal-bolus MDI therapy:
1. Basal insulin: Glargine, Degludec, or Determir
2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
5. Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
6. BMI \< 28 kg/m2
7. Subjects willing to follow study instructions:
1. For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM.
2. For CGM users: Use CGM according to manufacture instructions, Document insulin delivery, meals and daily activities.
8. Subjects have connection to the internet at home.
9. Subjects have a smartphone compatible with study requirements
10. Subjects willing and able to sign a written informed consent form.
Exclusion Criteria:
1. An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
2. Concomitant diseases/ treatment that influence metabolic control or 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 patients' safety
3. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
* Subject has unstable or rapidly progressive renal disease or is receiving dialysis
* Subject has active proliferative retinopathy
* Active gastroparesis
4. Participation in any other interventional study
5. Female subject who is pregnant or planning to become pregnant within the planned study duration
6. Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
7. Drug or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04043260
Study Brief:
Protocol Section:
NCT04043260