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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06529705
Eligibility Criteria:
Inclusion Criteria :
* Be over 18 years old;
* Have type 1, type 2, or pancreatogenic diabetes;
* Have been treated with multiple daily injections of insulin in a basal/bolus regimen for at least 6 months;
* Be using a continuous glucose monitoring device such as Dexcom G6, Dexcom One or Freestyle Libre for at least 2 weeks;
* Have a time in the glycemic target range (70-180 mg/dl) of less than 70%;
* Require at least 15 units of insulin therapy per day;
* Use a rapid-acting insulin compatible with the device, such as Novorapid, Humalog, Apidra, Asparte, Sanofi, Fiasp, or Lyumjev;
* Use a long-acting insulin compatible with the device, such as Lantus, Abasaglar, Toujeo, Levemir, or Tresiba;
* Be able to read and use a smartphone;
* Have no visual impairment requiring a specific font for smartphones;
* Have basic knowledge of smartphone use;
* Indicate their willingness to follow the protocol and sign a written informed consent
Exclusion Criteria:
* Ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within 6 months prior to inclusion;
* Treatment with any hypoglycemia-inducing agent other than insulin (including sulfonylureas and SGLT-2 inhibitors);
* Daily insulin requirement exceeding 200 U/day;
* Suffering from gastroparesis;
* Pancreatopathy secondary to chronic alcoholism;
* Known medical condition that, in the investigator's opinion, may interfere with the protocol;
* Participation in another clinical trial or administration of an unapproved medication within 4 weeks prior to screening;
* Not affiliated with a social security system;
* Vulnerable subject: minors, or adults under protection as defined by the Public Health Code, pregnant or breastfeeding women, subjects under guardianship or deprived of liberty;
* Person under legal protection;
* Person participating in another study with an ongoing exclusion period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06529705
Study Brief:
Protocol Section:
NCT06529705