AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).
Who can participate
Age range
6 Years – 13 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 ≥6.0 and ≤13 years old at time of consent
. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
. Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used.
. Currently using insulin for at least six months.
. Willingness to use lispro/aspart in the insulin pump during the study.
. Currently using a Dexcom G6 or G7 CGM.
. Has one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that live with participant.
. Participant not currently known to be pregnant or breastfeeding.
Exclusion criteria
. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic Diabetic ketoacidosis (DKA).
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.
What they're measuring
1
Non-inferiority of mean CGM between FCL and Usual Care