Health TrialsbyHealthPanel

Closed Loop Glucose Control in a Simulated ICU Setting

ConditionsType 1 DiabetesType 2 DiabetesStress Induced Hyperglycemia
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • FUSION closed loop glucose control system

    Device

    The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: FUSION closed loop glucose control system safety studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Safety Measure

The percentage of all glucose values \<70 mg/dL

Time frame
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

The percentage of all glucose values within the glucose range of 70-180 mg/dL

Time frame
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

Secondary outcomes

1

Percent of All Glucose Values Within Glucose Range <54 mg/dL

The percentage of all glucose values that are less than 54 mg/dL

Time frame
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours
2

Percent of All Glucose Values Within Glucose Range 54-69 mg/dL

The percentage of all glucose values that are within the glucose range of 54-69 mg/dL

Time frame
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of up to 24 hours.
3

Number of Hypoglycemic Events (<70 mg/dL)

The total number of hypoglycemic events less than 70 mg/dL as measured by a continuous series of glucose values less than 70 mg/dL for at least 15 minutes duration.

Time frame
From beginning of use of the FUSION System until end of use of the FUSION System, which will be a period of time of up to 24 hours.
4

Percent of All Glucose Values Within Glucose Range 70-100 mg/dL

The percentage of all glucose values within the glucose range of 70-100 mg/dL

Time frame
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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ideal Medical Technologies

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Emory University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: