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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT03478969
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed type 1 diabetes mellitus
* At least 6 months experience with MDI therapy
* Age ≥18 years and age ≤ 65
* Able to perform carbohydrate counting
* Clinically suitable for CSII including willingness to measure blood glucose at least 4 times per day or to use flash or real-time continuous glucose monitoring consistently
* HbA1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol) (determined within the last 2 months)
* Ability and willingness to read and understand study materials (participant information, data protection and written consent form, all questionnaires etc.) and to comply with study procedures
* Ability and willingness to use investigational devices independently and respond to alarms after training and run-in phase
* Using a blood glucose (BG)-meter or real-time continuous glucose monitoring device that can be downloaded via Accu-Chek® Smart Pix or willingness to use a compatible meter that will be provided for the duration of the study
Exclusion Criteria:
* Prior insulin pump use
* Relevantly impaired hypoglycemia awareness
* History of \>1 hospitalization due to severe hypoglycemia within the previous 3 months
* History of \>1 hospitalization due diabetic ketoacidosis within the last 3 months
* Significant manifestation of diabetes-related late complications
* Pregnant or planning to become pregnant or breastfeeding
* Known allergic reactions to plaster adhesive
* Chronic use (therapy lasting for more than 3 months) of steroids in adrenal suppressive doses, immunosuppressive medication, or chemotherapy
* Serious or unstable chronic medical or psychological condition(s)
* Addiction to alcohol or other substance(s) of abuse as determined by the investigator
* Psychological condition rendering the participant unable to understand the nature and the scope of the study
* Plans for relocation or extensive travel
* Participation in another clinical study within 4 weeks prior to the screening visit
* Dependency on Sponsor or Investigator (e.g. co-worker or family member)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03478969
Study Brief:
Protocol Section:
NCT03478969