None listed
Conditions
Brief summary
Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of diabetes. It occurs when the body does not have enough insulin and starts breaking down fat for energy, causing ketones (acids) to build up in the blood. Currently, clinical practice for detection of glucose and ketone levels are determined at specific time points duirng a hospital admission using fingerstick blood tests, which do not detect changes as they occur. The SiBionics dual continuous glucose and ketone monitor (CGKM) is a wearable device that continuously measures both glucose and ketone levels and may allow earlier detection of DKA than current clinical monitoring methods. This study will use the CGKM to monitor people with diabetes admitted to hospital with DKA and people with type 1 diabetes who are at risk of developing DKA. By examining CGKM patterns, we aim to better understand how DKA develops and assess whether continuous monitoring could support earlier detection and improved management of DKA in the future.
Interventions
Multi-site, blinded study, evaluating glucose and ketone profiles using the SiBionics Continuous Glucose and Ketone Monitor (CGKM). The CGKM is oval-shaped and is 24.8mm x 17.8mm x 2.9 mm in size. It will be inserted on the back of the upper arm. It will be inserted and removed by research study staff who have been appropriately trained and delegated on the study delegation log.
Two cohorts will be enrolled:
Cohort 1 includes at least 50 adults with type 1 diabetes (T1D) or type 2 diabetes (T
Multi-site, blinded study, evaluating glucose and ketone profiles using the SiBionics Continuous Glucose and Ketone Monitor (CGKM). The CGKM is oval-shaped and is 24.8mm x 17.8mm x 2.9 mm in size. It will be inserted on the back of the upper arm. It will be inserted and removed by research study staff who have been appropriately trained and delegated on the study delegation log. Two cohorts will be enrolled: Cohort 1 includes at least 50 adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) admitted to hospital with a clinical diagnosis of diabetic ketoacidosis (DKA). Cohort 2 includes at least 100 adults with T1D admitted for an acute illness without DKA. Following consent, a blinded/masked study CGKM will be inserted as close as possible to hospital presentation and worn throughout the inpatient admission to collect glucose and ketone data. Fidelity to intervention procedures will be monitored in hospital by reviewing in-person the CGKM is still in place or by auditing patient medical or nursing notes. On the day of discharge, for both cohorts, participants will have a new SiBionics CGKM inserted to wear for 14 days post-discharge, after which they will resume their pre-study standard care. The CGKM will be inserted prior to discharge home by research study staff who have been appropriately trained and delegated on the study delegation log. Participants will be provided instructions on how to remove the CGKM after 14 days post-discharge. Adherence to the CGKM inserted on the day of discharge after discharge home will not be assessed. Cohort-specific analysis will be performed separately for Cohort 1 and Cohort 2. Further outcome analyses will be undertaken where participants from Cohort 1 with type 1 diabetes and participants from Cohort 2 will be combined to form a larger type 1 diabetes group.
Sponsors
St Vincent's Hospital (Public) Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Other
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: *Age 18 years of age and over *Clinically diagnosed with T1D or T2D *Meet the criteria for DKA *Admitted to hospital as an inpatient. Cohort 2: *Aged 18 years of age and over *Clinically diagnosed with T1D *Admitted to hospital as an inpatient under medicine or surgery.
Exclusion criteria
Cohorts 1 and 2: *Pregnant women *Severe tape allergy *Clinically diagnosed with delirium *Cognitive impairment *Major medical or psychiatric illness that would interfere with protocol adherence *Individuals unable to read, speak, or understand English to a level of understanding of the PICF, 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 Cohort 2 Only: *Admitted under Day Stay, Short Stay and Hospital in The Home *Diagnosis of DKA .
Outcome results
None listed