Circulatory; Complications, Diabetes Mellitus, Dysglycemia, Perioperative Complication
Conditions
Keywords
Diabetes Mellitus, Continuous glucose monitoring, Medical devices
Brief summary
The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment. The main questions it aims to answer are: • Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment? Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.
Detailed description
This is a prospective observational study on patients living with diabetes who a) undergo surgery at the Department of Vascular Surgery, Rigshospitalet, Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Denmark, or b) are admitted to the intensive care unit (ICU) at Bispebjerg and Frederiksberg Hospital with circulatory impairment. The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment. The glucose readings will be compared to standard practice with POC blood glucose measurements. Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days. The study will include 60 patients This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery. Using this technology, postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care.
Interventions
A CGM device placed on the posterior aspect of the upper arm in which a sensor placed in the skin registers glucose values. Via Bluetooth, these readings are sent to a receiver near the patient every 5 minutes. The CGM system can alert when deviating glucose levels, but will for this observational study be blinding to patients and clinical staff. Thus, the patients' diabetic care will rely on standard practice.
Sponsors
University Hospital Bispebjerg and Frederiksberg
Rigshospitalet, Denmark
Steno Diabetes Center Copenhagen
Zealand University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical history with diabetes mellitus requiring antidiabetic drugs * Age ≥18 years * Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR * Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index \<1.5
Exclusion criteria
* Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area * Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc) * Known allergy to plaster used in the CGM device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between glucose | Perioperatively | Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements (matched pairs within 5 minutes) in the perioperative setting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between glucose readings when at low glucose levels | Perioperatively | Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at low glucose levels (\<3.9 mmol/l in the POC blood glucose measurement) |
| Agreement between glucose readings when at normal glucose levels | Perioperatively | Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at normal glucose levels (\>3.9-10.0 mmol/l in the POC blood glucose measurement) |
| Agreement between glucose readings when at high glucose levels | Perioperatively | Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at high glucose levels (\>10.0 mmol/l in the POC blood glucose measurement) |
Countries
Denmark
Contacts
STUDY_DIRECTOREske K Aasvang, MD, DmSci
Dept. of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Denmark
Outcome results
None listed