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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT05967260
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 1 diabetes mellitus for at least 1 year
* Male or female participants 18 years of age or older
* Using multiple daily injections
* HbA1c \<10% at screening
* Current use of a continuous glucose monitoring system with at least two episodes of overnight hypoglycemia (defined as sensed glucose \<70 mg/dL for at least 10 minutes between the hours of 10 PM and 6 AM) within 30 days prior to screening
* Individuals with history of severe hypoglycemia requiring third party assistance must have a companion in the same dwelling as the study participant who will be linked to the participant's Dexcom app during the control arm of the study, and who is trained in the administration of glucagon.
* Willingness to follow all study procedures
* Willingness to sign informed consent and HIPAA documents
Exclusion Criteria:
* Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence
* Any active infection
* Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use)
* Seizure disorder
* Use of non-insulin glucose lowering medications
* Use of steroids
* Stage-three or more advanced chronic kidney disease
* Hypo- or hyper- thyroidism that is not medically optimized and on a stable regimen define as Thyroid-stimulating hormone (TSH) outside of the normal reference range based on screening labs
* Adrenal insufficiency
* Cirrhosis
* Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
* Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol
* Individual working night shifts
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05967260
Study Brief:
Protocol Section:
NCT05967260