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:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT04653961
Eligibility Criteria:
Inclusion Criteria:
* Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
* Aged ≥ 14 years
* HbA1c of 6.5 ≤ A1c ≤ 10%
* Using basal-bolus MDI therapy:
1. Basal insulin: Glargine, Degludec, or detemir and up to sum of 72 units of basal insulin
2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
* Subjects willing to follow study instructions:
1. For SMBG users (only for segment 1): measure capillary blood glucose at least 4 times a day . Document blood glucose level, insulin delivery, meals and daily activities. Wear CGM.
2. For CGM users (FGM with a reader or real-time CGM): Use CGM according to manufacture instructions, document insulin delivery, meals and daily activities.
* Subjects using CGM or SMBG that are compatible with data transmission to the study diabetes management system (i.e. for CGM, FGM with a reader).
* Fasting glucose target is \< = 180 mg/dl (T2D)
* Subjects have home computer connected to the internet.
* Subjects have a smart phone compatible with study requirements.
* Subjects willing and able to sign a written informed consent form.
Exclusion Criteria:
* 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.
* 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
* 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
* Subject has loss of kidney function as measured by estimated Glomerular Filtration Rate (eGFR) \<45 in the previous 3 months 4. Participation in any other interventional study 5. Female subject who is pregnant or planning to become pregnant within the planned study duration
* Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
* Drug or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
75 Years
Study:
NCT04653961
Study Brief:
Protocol Section:
NCT04653961