Using continuous glucose monitors in the ICU for diabetes management
Continuous Glucose Monitoring in the Intensive Care Unit: Validation and Implementation
NA · University of Massachusetts, Worcester · NCT06190808
This study is testing if using a continuous glucose monitor in the ICU can help manage diabetes better than regular blood sugar checks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester (other) |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT06190808 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the use of the Dexcom G7 continuous glucose monitor (CGM) in the intensive care unit (ICU) setting. The study will involve collaboration with ICU staff to determine optimal placement and maintenance of the CGM devices on patients. Researchers will compare CGM readings with standard glucose measurements taken during routine care to assess accuracy and practicality. Additionally, the trial will monitor for any device malfunctions or adverse events related to the CGM usage.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with known diabetes or hyperglycemia (blood glucose ≥200 mg/dL) admitted to the ICU.
Not a fit: Patients unable to provide informed consent or those with conditions that interfere with sensor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve glucose monitoring accuracy in critically ill patients with diabetes, leading to better management of their condition.
How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring in various settings, but this specific application in the ICU is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. * Persons with either type 1 or type 2 diabetes. * Persons of either sex. * Persons of any age over 18. * Persons able to give informed consent or cognitively impaired adults whose legally authorized representative (LAR) can give informed consent. * English or Spanish speaking adults. Exclusion Criteria: * Persons unable to provide informed consent. * Cognitively impaired persons whose LAR declines to provide informed consent. * Patients receiving hydroxyurea, which interferes with sensor function. * Patients receiving high dose acetaminophen (\> 4 gm/day), which interferes with sensor function. * Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy. * Severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy. * Persons who are pregnant. * Prisoners.
Where this trial is running
Worcester, Massachusetts
- UMass Memorial Medical Center — Worcester, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: John P Mordes, MD — UMass Chan Medical School
- Study coordinator: John P Mordes, MD
- Email: john.mordes@umassmed.edu
- Phone: 6178884488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, ICU, CGM, Accuracy, Diabetes, Hypoglycemia, Diabetes mellitus, Continuous glucose monitor