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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT03809858
Eligibility Criteria:
Inclusion Criteria:
* Age 18 and over
* Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
* Willing to wear a CGM at least 70% of the time while in the study
* Willing to wear an Apple watch on their dominant hand while awake
* Missing or late in giving at least four food boluses in the previous 2 weeks
* Understanding and willingness to follow the protocol and sign informed consent
Exclusion Criteria:
* Pregnant or lactating women
* A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
* Current treatment for a seizure disorder
* Inpatient psychiatric treatment in the past 6 months
Subject may participate in another trial if it is approved by the investigators of both trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03809858
Study Brief:
Protocol Section:
NCT03809858