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HyperglycemiaNCT05442853

Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

A study testing Continuous glucose monitoring and Point of care glucose monitoring in people with Hyperglycemia and Hypoglycemia, run by Malcom Randall VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Hyperglycemia, Hypoglycemia, Critical Illness
What is being tested?
Continuous glucose monitoring and Point of care glucose monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
1 Apr 2023to 1 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Florida/South Georgia Veterans Health System

    Gainesville, Florida, 32608

Other trials in United States

About this study

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).

Read the detailed description

Study Purpose:

The purpose of this study is to compare the use of continuous glucose monitoring (CGM) versus point of care (POC) glucose monitoring in the intensive care unit (ICU) setting for differences in glycemic control and other important outcomes.

Research Plan:

This will be a prospective, single-center, randomized comparative trial of adult patients at North Florida/South Georgia Veterans Health System anticipated to be admitted to an ICU for a minimum of 48 hours after enrollment. Study participants will be randomly assigned to one of the study groups (CGM or POC) after being found eligible for inclusion and giving consent to participate. The CGM group will receive glycemic management based on CGM readings. The POC group will receive glycemic management based on POC glucose readings.

Study Outcomes:

Groups will be compared for differences in clinical and safety outcomes. The primary outcome will be the proportion of time in target range (BG 70-180mg/dL). Secondary outcomes will include mean glucose, hypoglycemia, hyperglycemia, ICU length of stay, mortality, glucose variability, cost, and patient satisfaction. Safety outcomes will include new infection, acute kidney injury, delirium, agitation, and pain.

Analysis Methods:

Descriptive statistics and inferential statistical methods will be used as appropriate to report findings of this study.

Being tested
Continuous glucose monitoring, Point of care glucose monitoring
Medical subject headings
Hyperglycemia, Hypoglycemia, Critical Illness, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous glucose monitoringDevice

    Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.

  • Point of care glucose monitoringDevice

    Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.

Study groups in NCT05442853
Study groupRoleWhat they receive
Continuous Glucose MonitoringActive comparatorStudy subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Receives: Device: Continuous glucose monitoring
Point of Care Glucose MonitoringActive comparatorStudy subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Receives: Device: Point of care glucose monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in Target Blood Glucose Range (BG 70-180mg/dL)

    Percentage of time within time glucose range based on CGM readings

    Measured: For duration of study enrollment (up to 10 days)

Secondary outcomes (16)

  1. Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL)

    Percentage of time with BG less than 54 mg/dl as measured by CGM

    Measured: For duration of study enrollment (up to 10 days)

  2. Time in Hypoglycemic Range (BG 54-69 mg/dL)

    Percentage of time in this glucose range as measured by CGM

    Measured: For duration of study enrollment (up to 10 days)

  3. Time in Hyperglycemic Range (BG 181-250 mg/dL)

    Percentage of time in this glucose range as measured by CGM

    Measured: For duration of study enrollment (up to 10 days)

  4. Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL)

    Percentage of time in this glucose range as measured by CGM

    Measured: For duration of study enrollment (up to 10 days)

  5. ICU Length of Stay

    Total time (in days or hours) in the intensive care unit

    Measured: At time of ICU discharge or death (assessed up to 1 month)

  6. ICU Mortality

    Death from any cause during ICU stay

    Measured: At time of ICU discharge or death (assessed up to 1 month)

  7. 30 Day Mortality

    Death from any cause at 30 days after admission to the ICU

    Measured: At 30 days or time of death

  8. Cost Associated With Monitoring

    Monetary value assigned to blood glucose monitoring

    Measured: For duration of study enrollment (up to 10 days)

  9. Mean Blood Glucose

    Average blood glucose (< 180 mg/dl) during the study timeframe

    Measured: For duration of study enrollment (up to 10 days)

  10. Glucose Variability

    1. % coefficient of variation = SD/mean BG*100%

    Measured: For duration of study enrollment (up to 10 days)

  11. Patient Satisfaction

    Patient satisfaction with glucose monitoring as assessed by survey on Likert Scale (1-5). Score of 1 being 'very dissatisfied' to score of 5 being 'very satisfied.'

    Measured: Once at completion of study enrollment (at day 10 or sooner)

  12. New Infection

    Any infection diagnosis that was not present upon admission to the ICU

    Measured: Assessed daily, For duration of study enrollment (up to 10 days)

  13. New Acute Kidney Injury

    New acute kidney injury (based on Acute Kidney Injury Network guideline definitions) not present upon admission to the ICU

    Measured: Assessed daily, For duration of study enrollment (up to 10 days)

  14. ICU Delirium

    Development of ICU delirium, based on Confusion Assessment Method for the ICU (CAM-ICU) score, with any positive score indicating presence of delirium.

    Measured: Assessed daily, For duration of study enrollment (up to 10 days)

  15. Agitation

    Richmond agitation scores (-5 to +4), with scores of +2 or more indicated agitation.

    Measured: Assessed daily, For duration of study enrollment (up to 10 days)

  16. Pain Associated With Glucose Monitoring

    Patient reported pain associated with glucose monitoring

    Measured: Assessed daily, For duration of study enrollment (up to 10 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start1 Apr 2023
  3. Primary completion30 Jun 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05442853
Sponsor's protocol ID
202201063
Status last verified
Mar 2025
First submitted
16 Jun 2022
Last updated
8 Apr 2025
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Franck AJ, Hendrickson AL, Telford ED, Davids BL, Murray Casanova I, Rosen AN, Hadigal S, Ross RC. Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients: A Randomized Controlled Trial. Chest. 2025 Aug;168(2):326-335. doi: 10.1016/j.chest.2025.02.006. Epub 2025 Feb 15.

    PubMed 39956190

Questions about this trial

What is this clinical trial studying?

A study testing Continuous glucose monitoring and Point of care glucose monitoring in people with Hyperglycemia and Hypoglycemia, run by Malcom Randall VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in Target Blood Glucose Range (BG 70-180mg/dL) (time frame: For duration of study enrollment (up to 10 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05442853, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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