N/A
N=85
Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
Hyperglycemia · Hypoglycemia · Critical Illness · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT05442853 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Time in Target Blood Glucose Range (BG 70-180mg/dL) — 60.5; 61.4 percentage of time within target range
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous glucose monitoring (Device); Point of care glucose monitoring (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Malcom Randall VA Medical Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Target Blood Glucose Range (BG 70-180mg/dL) |
60.5; 61.4 | — |
| SECONDARY Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL) |
0.2; 1.1 | — |
| SECONDARY Time in Hypoglycemic Range (BG 54-69 mg/dL) |
1.4; 0.9 | — |
| SECONDARY Time in Hyperglycemic Range (BG 181-250 mg/dL) |
29.6; 25.6 | — |
| SECONDARY Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL) |
8.0; 11.0 | — |
| SECONDARY ICU Length of Stay |
3.9; 4.6 | — |
| SECONDARY ICU Mortality |
3; 2 | — |
| SECONDARY 30 Day Mortality |
8; 2 | — |
| SECONDARY Cost Associated With Monitoring |
0; 0 | — |
| SECONDARY Mean Blood Glucose |
28; 27 | — |
| SECONDARY Glucose Variability |
21.0; 22.3 | — |
| SECONDARY Patient Satisfaction |
5; 4 | — |
| SECONDARY New Infection |
2; 2 | — |
| SECONDARY New Acute Kidney Injury |
6; 4 | — |
| SECONDARY ICU Delirium |
1; 1 | — |
| SECONDARY Agitation |
2; 1 | — |
| SECONDARY Pain Associated With Glucose Monitoring |
1; 4 | — |
Summary
The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit (ICU) who received continuous glucose monitoring (CGM) vs point of care (POC) glucose monitoring. The study will examine relevant outcomes for patients in the ICU with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).
Eligibility Criteria
Inclusion Criteria
- Patients age 18-89
- Past medical history of any diabetes mellitus OR patients with at least 1 measured BG of 180 being treated with insulin (subcutaneous or infusion)
- Enrollment will occur within 72 hours after being admitted to an ICU if history of diabetes
- Enrollment will occur within 72 hours after developing hyperglycemia in ICU if no diabetes
Exclusion Criteria
- Pregnant patients
- Patients using CGMs in the outpatient setting
- Diagnosis of diabetic ketoacidosis (DKA)
- Diagnosis of hyperosmolar hyperglycemic state (HHS)
- Anticipated to require prone positioning while on insulin therapy
- Any contraindications to CGMs based on manufacturer labeling
- BG above maximum reading for CGM (e.g. greater than 400 mg/dL)
- Receiving medication that could interfere with CGM readings (based on manufacturer specifications)
- Receiving any dose of hydroxyurea as this could falsely elevate the sensor readings (if applicable for specific CGM)
- Receiving greater than 1, 000mg acetaminophen every 6 hours in any form as this could falsely elevate the sensor readings (if applicable for specific CGM)
Data sourced from ClinicalTrials.gov (NCT05442853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.