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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
Enrollment will occur within 72 hours after developing hyperglycemia in ICU if no diabetes
Past medical history of any diabetes mellitus OR patients with at least 1 measured BG of 180 being treated with insulin (subcutaneous or infusion)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of icu discharge or death (assessed up to 1 month)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 developed high blood sugar in the ICU and I don't have diabetes.
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I have diabetes or have had a blood sugar level of 180 while on insulin.
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I must join the study within 3 days of ICU admission due to my diabetes.
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I am between 18 and 89 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time in target blood glucose range (BG 70-180mg/dL)
Secondary outcome measures
30 day mortality
Agitation
Cost associated with monitoring
+13 more

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

Find a Location

Who is running the clinical trial?

DexCom, Inc.Industry Sponsor
135 Previous Clinical Trials
29,507 Total Patients Enrolled
15 Trials studying Diabetes
3,728 Patients Enrolled for Diabetes
Malcom Randall VA Medical CenterLead Sponsor
7 Previous Clinical Trials
395 Total Patients Enrolled

Media Library

Continuous glucose monitoring (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05442853 — N/A
Diabetes Research Study Groups: Continuous Glucose Monitoring, Point of Care Glucose Monitoring
Diabetes Clinical Trial 2023: Continuous glucose monitoring Highlights & Side Effects. Trial Name: NCT05442853 — N/A
Continuous glucose monitoring (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05442853 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study currently open to new participants?

"Affirmative. Clinicaltrials.gov reveals that the study, which was posted on November 2nd 2022, is actively recruiting patients for participation. 300 individuals are being sought from 1 location."

Answered by AI

Are there any qualifications for eligibility in this research protocol?

"This clinical trial is enrolling 300 adult volunteers with diabetes or showing signs of hyperglycemia. To qualify, participants must be aged 18-89 and have either a documented case of diabetes mellitus or one blood glucose test result above 180 whilst receiving insulin therapy (either subcutaneous or intravenous). Enrolment will take place within 72 hours if the patient has previously been diagnosed with diabetes, and similarly within 72 hours after developing raised glucose levels in an ICU setting for those without such history."

Answered by AI

Is the elderly population being taken into consideration in this trial?

"To be eligible for this trial, patients must fall within the 18-89 age range. This research has a separate pool of 223 studies available to those under 18 and 1115 that are specifically targeting individuals over 65 years old."

Answered by AI

How many participants are being included in this clinical trial?

"Indeed, the latest update posted on clinicaltrials.gov verifies that this medical trial is still actively recruiting participants. Initiated on November 2nd 2022, it seeks to recruit 300 patients from a single site."

Answered by AI
~82 spots leftby Oct 2024