Closed Loop Glucose Control in a Simulated ICU Setting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIdeal Medical Technologies
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
Have a known hypersensitivity to any of the components of study treatment.
Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
Trial design
Treatments tested in this trial
- FUSION closed loop glucose control system
Treatment groups
6 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Ideal Medical Technologies
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Emory University
Collaborator
Source ClinicalTrials.gov