None listed
Conditions
Brief summary
Continuous glucose monitoring (CGM) devices are commonly used by people with diabetes to measure glucose levels using a small sensor placed under the skin. New sensor technologies may allow several important health markers, including glucose, ketones, and lactate, to be measured continuously using a single sensor. Monitoring ketones may help identify the early stages of diabetic ketoacidosis (DKA), a serious complication of diabetes, while lactate can provide information about how well the body's tissues are functioning. Measuring multiple markers at the same time could give healthcare professionals a more complete picture of a person's metabolic health than glucose monitoring alone. This study aims to evaluate the performance and potential clinical value of multi-analyte sensors, particularly in hospitalised patients where continuous monitoring may help detect health problems earlier. The findings may support the development of future monitoring technologies that improve patient care and safety both in hospital and community settings.
Interventions
Single-site, blinded study, evaluating glucose, ketone, lactate and oxygen profiles using the PercuSense Atlas Health Multi-Analyte Sensor (MAS). All participants will be recruited through ICU. Three cohorts will be enrolled. Arm 1 includes adults admitted with diabetes who meet the clinical criteria of diabetic ketoacidosis (DKA). Arm 2 includes adults with hypoxemic respiratory failure. Arm 3 includes adults with circulatory compromise. Following consent, a blinded/masked study MAS will be ins
Single-site, blinded study, evaluating glucose, ketone, lactate and oxygen profiles using the PercuSense Atlas Health Multi-Analyte Sensor (MAS). All participants will be recruited through ICU. Three cohorts will be enrolled. Arm 1 includes adults admitted with diabetes who meet the clinical criteria of diabetic ketoacidosis (DKA). Arm 2 includes adults with hypoxemic respiratory failure. Arm 3 includes adults with circulatory compromise. Following consent, a blinded/masked study MAS will be inserted using the device applicator into the upper arm by a study team member. The MAS will be worn throughout the inpatient admission to collect glucose, ketone, lactate and oxygen data. In addition, the commercially available Abbott FreeStyle Libre 2 Plus continuous glucose monitor (CGM) will be inserted into the contralateral arm. The sensors will be worn for up to three days as an inpatient in ICU. After three days or at the time of discharge the study MAS and Libre CGM sensors will be removed by a study team member. If the participant remains in ICU for more than six days, the insertion of a second device will be considered as determined by the study doctor and the Libre CGM will remain in place until the second MAS is removed. Intervention fidelity will be assessed using data uploaded from the MAS device throughout the participant's ICU stay. The three cohorts in this study were developed to ensure that we had a sufficient range of readings pertinent to any given analyte. Each condition would provide significant variation specific parameters measured (eg respiratory failure would ensure readings in the hypoxic range; DKA would ensure elevated ketone readings etc) Therefore the primary analysis will be for data provided by the group as a whole.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort 1: • Men and non-pregnant women • Aged 18 years of age and over • Clinically diagnosed with T1D or T2D • Meet the criteria for DKA • Admitted to hospital as an inpatient into ICU Cohort 2: • Men and non-pregnant women • Aged 18 years of age and over • Clinically diagnosed with hypoxaemic respiratory failure • Admitted to hospital as an inpatient into ICU Cohort 3 • Men and non-pregnant women • Aged 18 years of age and over • Clinically diagnosed with circulatory compromise requiring pressor support • Admitted to hospital as an inpatient into ICU
Exclusion criteria
Individuals who meet the following inclusion criteria at screening will be excluded from participating in this study at the time of screening: • Under 18 years of age • Pregnant women • Patients who are anti-coagulated • Patients planned for MRI scans • Severe tape allergy • Major medical or psychiatric illness that would interfere with protocol adherence • Individuals unable to read, speak, or understand English, or those for whom translation services/certified translated documents are not available • Any other reason that in the opinion of the investigator would prevent the subject from completing study procedures.
Outcome results
None listed