Closed Loop Glucose Control in a Simulated ICU Setting (NCT07646067) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Closed Loop Glucose Control in a Simulated ICU Setting
6 participantsStarted 2026-07
Plain-language summary
This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.
The persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg/dL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.
Who can participate
Age range
18 Years – 70 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
. Are 18-70 years of age, inclusive.
. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 3 months.
. Use insulin injections at home for glucose control.
. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
. Have a hemoglobin in the range for sex:
. Females: 7-15.5 grams/dL.
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.
1This trial is testing closed loop glucose control in a simulated ICU setting — does that mean it's not being tested on actual hospitalized patients yet, and what does that mean for how much is already known about its safety and effectiveness?
2Since this study covers Type 1 diabetes, Type 2 diabetes, and stress-induced hyperglycemia, which of those categories does my situation fall into, and does that affect whether this research would even be relevant to my care?
3The trial is listed as 'not yet recruiting' — do you have any idea when it might open, and is it worth waiting for, or should we focus on other options for managing my glucose levels in the meantime?
4The study is measuring both a primary safety outcome and a primary efficacy outcome for closed loop glucose control — what kinds of safety risks are typically associated with automated insulin delivery systems in an ICU-type environment that I should understand before considering anything like this?
5Given that this appears to be an early-stage study in a simulated rather than real ICU setting, would standard approaches to glucose management in critically ill patients be a more established path for someone in my situation right now?
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
Primary Safety Measure
Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours
2
Primary Efficacy Measure
Timeframe: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours