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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT04439903
Eligibility Criteria:
Inclusion Criteria:
* Age ≥21 and ≤65 years old at time of consent.
* Clinical diagnosis, based on investigator assessment, of T1D for at least one year.
* Using insulin for at least 1 year prior to study enrollment.
* Using an insulin pump for at least 6 months prior to study enrollment.
* Currently using a CGM for at least 6 months.
* Willingness to use a Dexcom G6 CGM during the study; a study Dexcom CGM will be provided if needed.
* Current user of the Tandem t:slim X2 insulin pump.
* Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
* Total daily insulin (TDI) dose at least 10 U/day.
* HbA1c ≤9.0% at screening; if HbA1c \<6.0%, then TDI must be ≥ 0.5 U/kg.
* Having access to internet (Wi-Fi or 3G, 4G, 5G, or similar).
* Willingness to interact with a computer program.
* An understanding of and willingness to follow the protocol and sign the informed consent form (ICF).
Exclusion Criteria:
* Participants who are not able to read and complete questionnaires on the computer or interact with a program for which they will be trained because of language, reading, or cognitive issues.
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
* History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist and not currently on a seizure medication.
* Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures.
* If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
* A known medical condition that in the judgment of the investigator might interfere with the completion of the study.\*
* Abuse of alcohol or recreational drugs.
* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, etc).
* Uncontrolled arterial hypertension (resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg).
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
* Current use of the following drugs and supplements:
* Any drug other than insulin to treat diabetes.
* Any other medication that according to the investigator's criteria is a contraindication for the subject's participation.
* Note: The software implementation, in the current development status, is designed to interact with subjects with T1D that only use insulin for diabetes treatment and do not present any comorbidity related to diabetes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT04439903
Study Brief:
Protocol Section:
NCT04439903