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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06329297
Other study ID # NUR23-1005 INPTCGM1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date April 2025

Study information

Verified date March 2024
Source Parkview Health
Contact Philip Roberts
Phone 260-266-2261
Email Philip.roberts@parkview.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations.


Description:

The use of continuous glucose monitors (CGM) in the outpatient setting has dramatically increased as these devices continue to improve in both ease of use, accessibility, and accuracy. Federal Drug Administration (FDA) clearance of certain devices has now been granted in both pregnancy and automated insulin delivery systems. As the world has embraced the safety and efficacy of continuous glucose monitors in the outpatient setting, health systems have turned attention to the potential of utilizing these devices to improve glycemic control in the hospital setting. With the announcement of the FDA granting enforcement discretion regarding the use of CGM technology in the hospital setting during the COVID-19 pandemic, the result was an abundance of research evaluating the potential of CGM longevity in the hospital setting. The Standards of Care in Diabetes: 2023 reported that "preliminary data suggests that CGM can significantly improve glycemic management and other hospital outcomes." Additionally, a systematic review of 32 studies evaluated the accuracy of CGM in the intensive care unit, with a consensus of moderate to good accuracy. CGM in the hospital setting could provide a valuable tool in reducing hypoglycemia, hyperglycemia, and increasing time spent in normoglycemia. Other potential benefits of CGM include a broader view of glucose patterns, capture of asymptomatic hypoglycemia, reduced length of stay, and decreased cost. The Diabetes Technology Society organized the Hospital Consensus Guideline Panel in 2020, with the final report including the recommendation for additional research on the accuracy, data management, and patient-centered outcomes of CGM use in the inpatient setting.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date April 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Admitted patients 18 years of age or older - Glucose management per Glucommander and/or receiving POC blood glucose testing - Patients admitted to Medical 6 or elective or urgent open-heart surgery patients admitted to the Cardiovascular Intensive Care Unit (CVICU) Exclusion Criteria: - Patients less than 18 years of age - Pregnant or currently breastfeeding - Prisoners - Patients unable to consent in English. - Patients with a preexisting insulin pump on admission - Active skin infection at the insertion site(s)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CGM monitor
blood glucose sensor used to monitor interstitial glucose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Parkview Health

References & Publications (2)

Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, Lohnes S, Nichols JH, Spanakis EK, Espinoza J, Palermo NE, Awadjie DG, Bak L, Buckingham B, Cook CB, Freckmann G, Heinemann L, Hovorka R, Mathioudakis N, Newman T, O'Neal DN, Rickert M, Sacks DB, Seley JJ, Wallia A, Shang T, Zhang JY, Han J, Klonoff DC. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol. 2020 Nov;14(6):1035-1064. doi: 10.1177/1932296820954163. Epub 2020 Sep 28. — View Citation

van Steen SC, Rijkenberg S, Limpens J, van der Voort PH, Hermanides J, DeVries JH. The Clinical Benefits and Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients-A Systematic Scoping Review. Sensors (Basel). 2017 Jan 14;17(1):146. doi: 10.3390/s17010146. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CGM vs point of care test (POCT) glucose Continuous interstitial glucose monitor readings compared to point of care capillary blood glucose readings from date of admission up to 7 days
Secondary Slow downward trend arrow on CGM device impact on hypoglycemia events from date of admission up to 7 days
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