Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Re… (NCT03258853) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
United States22 participantsStarted 2021-08-26
Plain-language summary
The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children with cystic fibrosis related diabetes.
Who can participate
Age range
10 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 \>/= 10 years and have had a diagnosis of cystic fibrosis related diabetes (CFRD) managed using either an insulin pump or multiple daily injections (MDI).
* Mean continuous glucose monitoring (CGM) glucose \>/=125 mg/dl as determined by the participant's personal CGM 30-day download if CGM is used as part of their usual care. If the participant does not use CGM, hemoglobin A1c \>/= 6% within the last 6-months from available medical records will be required.
* Minimum insulin requirement of \>/=0.1u/kg/day. To ensure that participants with a wide range of insulin requirements are included, participants whose insulin requirement is \<0.3u/kg/day will be limited to approximately 1/3 of the enrolled \>/=18 year old adult cohort.
* Willing to wear iLet infusion sets and one Dexcom CGM sensor and change sets at least every other day in the iLet arm
* Assent will be obtained for patients \<18 of age
Exclusion criteria
* Diabetes from etiologies other than CFRD
* Unable to provide informed consent (e.g. impaired cognition or judgment)
* Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)
* Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the participant
* Pregnancy (positive urine HCG)…
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
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14