Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in A… (NCT07212179) | Clinical Trial Compass
CompletedNot Applicable
Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
United States2 participantsStarted 2026-03-03
Plain-language summary
To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery.
Who can participate
Age range
14 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥14.0 and ≤21 years old at time of consent
. HbA1c ≤ 10%.
. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
. Having used an insulin pump within the last three months.
. Currently using insulin for at least six months
. Willingness to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
. Willingness to switch to a commercially approved insulin (e.g. lispro or aspart or biosimilar approved products) within the study pump as directed by the study team.
. Has one or more supportive caregivers or companions living with the participant who are knowledgeable about emergency procedures for treatment of severe hypoglycemia and able to contact emergency services and study staff.
Exclusion criteria
. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.