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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT03711656
Eligibility Criteria:
Inclusion Criteria:
* Patients \> 18 years with Type 1 Diabetes:
* \> 4 hypoglycemia / week (\< 70 mg/dl, including day and night), last 2 weeks and / or
* One severe hypoglycemia during the last year and / or
* Hypoglycemia unawareness (Clarke Test \>3)
* Disease duration \> 5 years
* On multiple doses of insulin (MDI) therapy using a rapid acting insulin analogue as prandial insulin (lispro, aspart or glulisine) and any basal analogue as basal insulin.
* A1c 6.5 - 9.5 %
* Able to use an intermittently scanned continuous glucose monitoring (isCGM) system.
* Performing \>4 self-monitoring blood glucose (SMBG) per day
* Using carb-counting
* Providing an informed consent
* No CGM user previously (during the last 3 months).
Exclusion Criteria:
* Patients with a previous Diabetic Ketoacidosis (DKA) episode in the previous 6 months.
* Patients with a severe hypoglycemia in the previous 6 months.
* Severe diabetic complications or comorbidities: eye, renal, cardiovascular...from the clinicians point of view.
* Pregnancy and breastfeeding.
* History of drug or alcohol abuse.
* Scheduled surgery during the study period.
* Mental conditions that prevent the subject to understand the nature, purpose and possible consequences of the study.
* Subjects those are unlikely to meet the clinical study protocol, eg uncooperative attitude, inability to return for follow-up visits, or poor probability of completing the study.
* Using an experimental drug or device during the past 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03711656
Study Brief:
Protocol Section:
NCT03711656