Health Trials

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 group

Locations

This trial has no locations

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