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Device

Continuous Glucose Monitoring for Hyperglycemia in Critical Illness

N/A

Recruiting

Research Sponsored by Malcom Randall VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Past medical history of any diabetes mellitus OR patients with at least 1 measured BG of 180 being treated with insulin (subcutaneous or infusion)

Be older than 18 years old

Must not have

Anticipated to require prone positioning while on insulin therapy

Diagnosis of diabetic ketoacidosis (DKA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of icu discharge or death (assessed up to 1 month)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two methods of glucose monitoring in ICU patients with diabetes or hyperglycemia to see which one keeps blood glucose in target range most.

Who is the study for?

This trial is for adults aged 18-89 in the ICU with a history of diabetes or those who develop high blood sugar while in the ICU. It's not for pregnant individuals, patients with diabetic ketoacidosis, hyperosmolar hyperglycemic state, or those on certain medications like hydroxyurea that interfere with glucose monitoring.

What is being tested?

The study compares continuous glucose monitoring (CGM) to standard point of care (POC) testing in ICU patients with diabetes or high blood sugar. The main goal is to see how well each method keeps blood sugar within the target range of 70-180 mg/dL.

What are the potential side effects?

While CGMs are generally safe, potential side effects include skin irritation at the sensor site and inaccurate readings if certain medications are used or if blood glucose levels are very high.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have diabetes or have had a blood sugar level of 180 while on insulin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will need to lie face down for treatment while on insulin.

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I have been diagnosed with diabetic ketoacidosis.

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I am not taking hydroxyurea as it may affect my test results.

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I have been diagnosed with a severe form of high blood sugar.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of icu discharge or death (assessed up to 1 month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of icu discharge or death (assessed up to 1 month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of icu discharge or death (assessed up to 1 month) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time in target blood glucose range (BG 70-180mg/dL)

Secondary study objectives

30 day mortality

Agitation

Cost associated with monitoring

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Continuous Glucose MonitoringActive Control1 Intervention

Study 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.

Group II: Point of Care Glucose MonitoringActive Control1 Intervention

Study 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

0 / 5Eligibility criteria met