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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT03260868
Eligibility Criteria:
Inclusion criteria :
* Participants with Type 1 diabetes mellitus (T1DM) diagnosed at least one year before the screening visit.
* Participants who were treated with multi-dose insulin using insulin glargine 100 U/mL (eg, Lantus or Basaglar) as basal insulin and rapid acting insulin analogues as bolus insulin.
* Participants with access to or experience with mobile technology (eg, tablet or smart phone).
* eSign the consent on the study web portal.
Exclusion criteria:
* Age less than (\<) 18 years at screening (Visit 1 - Step 1).
* Type 2 diabetes mellitus.
* HbA1c \<5.4 percent (%) or greater than or equal to (\>=) 9.0% measured by the central lab at Visit 1.
* Participants who received \<6 months treatment with any basal plus (+) meal-time insulin.
* Use of any basal insulins other than insulin glargine 100 U/mL (eg, Lantus or Basaglar) within 3 months before screening.
* Use of an insulin pump within 6 months before screening.
* Use of meal-time insulin other than rapid-acting insulin analogs (Humalog, Novolog, or Apidra), eg, human regular insulin, within 30 days before screening.
* Hemoglobinopathy resulting in undetectable HbA1c by the central laboratory, or hemolytic anemia requiring transfusion of blood or plasma products within 3 months before screening.
* Participants experienced with any severe hypoglycemic episode resulting in seizure, unconsciousness, or coma, and/or leading to hospitalization during the past 6 months before screening.
* Participants with insufficient smart phone skills or unwilling to properly use the virtual tools deemed by the investigator based on the observation and experiences over the digital screening procedure-Mental disorders or any neurologic disorder that would affect participant's ability to meet the study requirements, or participants deemed unlikely to safely manage insulin dosage by the investigator.
* Known hypersensitivity/intolerance to insulin glargine, rapid-acting insulin analogs or any of their excipients.
* Pregnant or breast-feeding women, or women who intend to become pregnant during the study period.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03260868
Study Brief:
Protocol Section:
NCT03260868