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Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus

Primary Purpose

Diabete Mellitus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor (CGM)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabete Mellitus focused on measuring CGM, Continuous Glucose Monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CGM Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

CGM accuracy - mean absolute relative difference (MARD)
MARD will be calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings <70g/dl, >180g/dl, >250g/dl respectively.

Secondary Outcome Measures

CGM recorded hypoglycemia episodes
The incidence and duration of hypoglycemic episodes
CGM recorded hyperglycemia episodes.
The incidence and duration of hyperglycemic episodes
Variation in MARD in relation to pharmacological and physiological parameters
The effect of antibiotics, glucocorticoids, vasopressors, dose of immunosuppressive medications, hypotension/hypertension, hypoxemia, lactic acidosis on CGM accuracy.
In hospital mortality
Mortality during index hospitalization
Hospitalization length of stay
Duration of hospital stay in days.
Mortality rate at 30 days
Readmission rate at 30 days
Number of patients that got readmitted to the hospital after discharge following the index hospitalization.

Full Information

First Posted
November 6, 2020
Last Updated
January 7, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04653454
Brief Title
Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus
Official Title
CGM Use in Hospitalized Patients With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 2, 2024 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
Detailed Description
All patients admitted to the hospital in inpatient or observation status and having a Continuous Glucose Monitor (CGMs) attached will be screened and identified by providers and nurses. An order will be placed by providers to continue patient's home CGM use in the hospital. "CGM patient agreement" describing the hospital policy for use of CGMs will be provided to the patient for signature. Patients will be encouraged to continue to wear their CGMs in the hospital unless their presence interferes with patients' medical care. CGM presence will be recorded by nursing in patient chart under LDA (lines, drains, airway) section. Patients will be approached by the research staff and will be offered enrollment in the study. A research consent will be reviewed with patients and will be provided for signature. Patients will be asked to continue to use their home CGMs in the hospital. If CGM sensor will reach the end of life, patients have the option to place a new sensor and to follow manufacturer recommendations for calibration and setting. Patients are responsible to provide their own sensors, transmitters and readers during the hospitalization period. If it is determined that the current sensor will interfere with hospital medical and surgical care (MRI testing, procedure at the site), patients will be asked to remove the CGM sensor and transmitter. Patients will have the option to replace the sensor after the procedure if they so desire. Patients will continue to monitor their glucose level via CGM. For flash sensors, patients will be asked to scan their sensor at least every 8 and as needed. CGMs that require calibration will be calibrated by the patients using hospital glucometer readings. . Patients alerted by their CGM about low glucose levels or fast downward or upward trending will have to notify their nursing staff. A POC blood glucose check will be done by nursing staff to confirm the alert or the trend. Treatment decisions will be made based on POC readings. During hospitalization patients will continue to have their blood glucose checked with POC glucometers per hospital policy. Treatment of diabetes and the associated complications, dosing of insulin, change from PO to insulin treatment and back to PO medications during hospitalization or at discharge will be done by the admitting team with help from the inpatient Endocrinology Consultation Service. Decisions about insulin dosing or other diabetes treatments will be made based on hospital glucometer readings, and not based on CGM readings alone. Patients will be asked to give the research team "provider access" to their cloud CGM software, or to allow the team to download their CGM data prior to discharge if their reading devices do not automatically synchronize with the cloud software. CGM data will be compared with POC glucometer readings obtained in the hospital at approximately the same time. Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. The accuracy of CGM for glucose measurement in the hospital will be calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Mellitus
Keywords
CGM, Continuous Glucose Monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CGM Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor (CGM)
Intervention Description
CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time.
Primary Outcome Measure Information:
Title
CGM accuracy - mean absolute relative difference (MARD)
Description
MARD will be calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings <70g/dl, >180g/dl, >250g/dl respectively.
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Secondary Outcome Measure Information:
Title
CGM recorded hypoglycemia episodes
Description
The incidence and duration of hypoglycemic episodes
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
CGM recorded hyperglycemia episodes.
Description
The incidence and duration of hyperglycemic episodes
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
Variation in MARD in relation to pharmacological and physiological parameters
Description
The effect of antibiotics, glucocorticoids, vasopressors, dose of immunosuppressive medications, hypotension/hypertension, hypoxemia, lactic acidosis on CGM accuracy.
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
In hospital mortality
Description
Mortality during index hospitalization
Time Frame
From date of admission and until discharge from the hospital up to 30 days.
Title
Hospitalization length of stay
Description
Duration of hospital stay in days.
Time Frame
From date of admission and until discharge from the hospital up to 30 days.
Title
Mortality rate at 30 days
Time Frame
30 days post discharge from the hospital.
Title
Readmission rate at 30 days
Description
Number of patients that got readmitted to the hospital after discharge following the index hospitalization.
Time Frame
30 days post discharge from hospital.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Dumitrascu, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Continuous Glucose Monitoring in Hospitalized Patients With Diabetes Mellitus

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