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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT02609633
Eligibility Criteria:
Inclusion Criteria:
* Children or adolescents, aged 6 to 18 years
* Diagnosis of T1D for at least 3 months
* Currently managed with insulin Multiple Daily Injection (MDI) therapy
* Attending full-day school schedule in Grade K through 12
* Able to provide SMBG data minimum of one month prior to study start
* Currently using a compatible Smartphone with ability to download the Accu-Chek® CONNECT System App accordingly OR ability to utilize Smartphone and Accu-Chek® CONNECT System App as provided for use in study
* Adolescents (18 years) with diabetes provide written informed consent
* Children 7 to 17 years to provide age-appropriate child assent
* Parent/caregiver currently using a compatible Smartphone with ability to receive Short Message Service/Multimedia Messaging Service (SMS/MMS) messages
* Able to read/write in English and comply with study procedures, including provision of self-monitoring blood glucose (SMBG) data at least 1 month prior to the study
Exclusion Criteria:
* Current or planned use of continuous subcutaneous insulin infusions during the study period
* Use of continuous glucose monitoring or a remote data-sharing system/device (i.e. NightScout, DexCom Share, Medtronic Connect) during the study
* Pregnancy
* Clinically significant medical condition(s) such as anemia, major organ system disease, infection, psychosis, or cognitive impairment
* Requirement for chronic steroids, immunomodulatory medication, or chemotherapy in adrenal suppressive doses
* Visual impairment preventing use of the Accu-Chek® CONNECT system
* Parent/caregiver is an investigator, general practitioner, practice staff, pharmacist, research assistant, or other staff or relative of those directly involved in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT02609633
Study Brief:
Protocol Section:
NCT02609633