Extended Bolus for Meals in a Closed-loop System (NCT05454891) | Clinical Trial Compass
CompletedNot Applicable
Extended Bolus for Meals in a Closed-loop System
United States30 participantsStarted 2022-07-15
Plain-language summary
This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.
Who can participate
Age range
13 Years – 19 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 between 13 and 19 years old, A1C \> 6% at screening
* Diagnosed with type 1 diabetes for at least one year
* Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day
* Currently using the Control IQ closed-loop system
* Willing to abide by meal recommendations and study procedures
* Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF
* Use an Android or Apple smartphone
* Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
* Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
* Parent/guardian proficient in reading and writing English
* Live in the United States, with no plans to move outside the United States during the study period
Exclusion Criteria
* A1C \>10%
* One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months
* Used non-insulin anti-diabetic medication within the last 30 days other than metformin
* Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease
* Pregnancy or lactation
* Untreated or unstable hypothyroidism
* Currently undergoing cancer treatment or systemic treatment with steroids
* Untreated or inadequately treated mental illness
* Current alcohol abuse
* Current illness that would interfere with participation in the study
* Delayed gastr…
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.