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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT03428295
Eligibility Criteria:
Inclusion Criteria:
* Participants must have type 1 diabetes for greater than 1 year
* Have a hemoglobin A1c less than 9.0%
* Participants in the FACL arm must report that they engage in aerobic exercise at least 30 minutes three times weekly
* If participants in the FACL arm are age \>35 OR duration of T1D \>15 years OR history of T1D complications (proliferative retinopathy, nephropathy, peripheral vascular disease, autonomic neuropathy), participant must have EKG within normal limits obtained within last 6 months of study date
* Age 18-70
* Fluent and literate in English
* Use of an insulin pump for ≥ 3 months
* Use of a CGM/sensor for ≥ 5 days/week for ≥3 months
* Must have a diabetes care provider
* Use of an effective birth control method for women who are sexually active and of childbearing potential
* Willing and able to give informed consent
Exclusion Criteria:
* History of ≥ 1 episode of severe hypoglycemia (defined as hypoglycemia leading to loss of consciousness, seizure, or requiring assistance) in the previous 6 months
* History of ≥ 1 episode of DKA in the previous 6 months
* History of cardiovascular disease, characterized by any of the following:
* Prolonged QT or arrhythmia
* History of myocardial infarction within the past 6 months
* History of ischemia on functional cardiac exam within the last year
* History of left ventricular ejection fraction \< 30%
* Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg)
* Current use of a beta blocker
* Stage 3 or greater renal disease
* Untreated thyroid disease
* History of substance abuse
* Current or previous use of medications for control of a seizure disorder
* Enrolled in another clinical trial in which they received investigational drug in the last 12 weeks
* Inability to comply with protocol
* Pregnant or breast feeding
* Use of medications other than insulin to control glucose
* Chronic corticosteroid use
* Pre-existing medical conditions deemed by study investigator to interfere with the study or increase risks of study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03428295
Study Brief:
Protocol Section:
NCT03428295