Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus

NCT04653454 | Completed Results FDA Device

• 1 other identifier: 20-008826
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital would prevent episodes of hyperglycemia and hypoglycemia.

Conditions

Diabetes Mellitus

Keywords

CGM, Continuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

• Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD)

  The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings \<70 mg/dl, 70-180 mg/dL, \>180 mg/dl, 181-250mg/dl, \>250 mg/dl respectively.

  From date of enrollment and until discharge from the hospital up to 30 days.

Secondary Outcomes (9)

• CGM Recorded Hypoglycemia Episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

• CGM Recorded Duration of Hypoglycemic Episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

• CGM Recorded Hyperglycemic Episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

• CGM Recorded Duration of Hyperglycemic Episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

• Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters

  From date of enrollment and until discharge from the hospital up to 30 days.

Study Arms (1)

CGM Patients

EXPERIMENTAL

Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff.

Device: Continuous Glucose Monitor (CGM)

Interventions

Continuous Glucose Monitor (CGM) DEVICE

CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time.

CGM Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Type 1 or 2 Diabetes Mellitus,
• Patients 18 years of age or older,
• Patients admitted under medical or surgical services.
• Patients treated with diet alone, insulin (SQ, insulin pump) or oral hypoglycemic medications.
• Have their own Continuous Glucose Monitoring (CGM) monitor present on admission or able to be placed after admission.

You may not qualify if:

• Individuals under 18 years of age.
• COVID-19 infection.
• Infection of the skin at the CGM site requiring removal of the sensor.
• Patients with altered Mental Status.
• Patients unable to scan their flash CGMs at least every 8 hours.
• Inability to provide written consent.
• Hospitalized for less than 24 hours.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Adrian Dumitrascu M.D.
• Organization: Mayo Clinic

Dumitrascu.Adrian@mayo.edu

904-956-0081

Study Officials

• Adrian Dumitrascu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: December 4, 2020
• Study Start: January 1, 2021
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)