Remote Glucose Monitoring System in Hospitalized Patients With Diabetic Ketoacidosis (DKA)

April 28, 2025 updated by: Magdalena M. Bogun, MD, Columbia University

Remote Glucose Monitoring Using the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Hospitalized Patients With Diabetic Ketoacidosis (DKA)

The purpose of this research study is to investigate the use of continuous glucose monitoring (CGM) device DEXCOM G6 in non-critically patients treated for diabetic emergency such as diabetic ketoacidosis (DKA). Patients who have DKA require hourly monitoring of glucose (sugar) level which traditionally requires admission to the intensive care unit (ICU) for hourly fingerstick monitoring. With the use of CGM device, in this research study hourly fingerstick monitoring is replaced by continuous glucose monitor (CGM) which provides glucose levels continuously in real time for nurses and provider. The investigators are testing to see if in the future patients can be treated in the stepdown unit (an intermediate care level between the intensive care unit and the general medical unit) if they do not require higher level of care besides hourly glucose monitoring. Continuous glucose monitoring (CGM) device DEXCOM G6 currently FDA Approved for patients with diabetes and is widely used for glucose monitoring in patients with diabetes in the outpatient setting. The investigators want to study the use of the DEXCOM G6 CGM in the inpatient setting to monitoring glucose levels remotely in the treatment of diabetic emergencies such as diabetic ketoacidosis and compare their care to those receiving hourly fingerstick glucose monitoring in the ICU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the height of the COVID-19 pandemic, the investigators launched a quality improvement project with the goal of treating non-critically ill DKA patients outside of ICU setting to reallocate ICU beds for critically ill patients. The standard of care is for DKA patients to be treated in the ICU setting because the DKA protocol requires hourly fingerstick glucose monitoring, which is considered higher level of care and not appropriate for stepdown unit or medical/surgical wards. During this quality improvement project, the investigators monitored glucose levels remotely with continuous glucose monitoring (CGM) device DEXCOM G6, eliminating the need for hourly fingerstick glucose testing. Therefore, patients with DKA whose glucose levels were monitored with DEXCOM G6 CGM were treated in the stepdown unit instead of the ICU setting.

Once the number of COVID cases decreased and ICU beds were more readily available, the hospital returned to practicing pre-COVID standard of care, which was admitting DKA patient to the ICU for hourly glucose monitoring.

This study is a combined retrospective and prospective study of DKA patients. The investigators propose a retrospective chart review of DKA patients who had glucose levels monitored with DEXCOM G6 CGM during the COVID-19 pandemic. In the prospective portion of this study, participants will be enrolled and will undergo continuous glucose monitoring with DEXCOM G6 instead of the hourly fingerstick point of care glucose testing. Data collected for participants monitored via DEXCOM G6 (retrospective and prospective study data combined analysis) will be compared to participants with glucose levels monitored via hourly fingerstick in the ICU setting.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital/ Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years
  • AG>20 mEq/L
  • Bicarbonate <15mEq/L
  • Positive urine ketones or beta hydroxybutyrate >0.3 mmol/L

Exclusion Criteria:

  • Hypotension (Blood Pressure below 80/60 mmHg)
  • Requirement for pressor therapy
  • Contraindication for utilizing Dexcom CGM

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEXCOM G6 CGM
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA. This group comprises of both retrospective chart review and prospective patients.
Device: DEXCOM G6 CGM
Continuous glucose monitoring
No Intervention: Hourly Finger Stick Point of Care (Historical Control)
DKA patients that received hourly glucose monitoring by finger stick while triaged through the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Resolution of Metabolic Acidosis
Time Frame: Up to 10 days
Time to resolution of metabolic acidosis measured in hours. Resolution defined as anion gap (AG) <17 mEq/L and bicarbonate >19 mEq/L.
Up to 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU Stay
Time Frame: Up to 20 days
Length of ICU stay measured in days
Up to 20 days
Number of Hypoglycemic Events
Time Frame: Up to 20 days
The number of hypoglycemic events will be recorded. A hypoglycemic event is defined as glucose level <70 mg/dL.
Up to 20 days
Length of Hospital Stay
Time Frame: Up to 20 days
Length of hospital stay measured in hours
Up to 20 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost Savings
Time Frame: Up to 20 days
Cost savings calculated by comparison of cost when non-critically DKA participants have glucose levels monitored via CGM and treated in the stepdown unit compared to participants who have glucose levels monitored via hourly fingersticks and treated in the ICU.
Up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

DexCom, Inc.

Investigators

  • Principal Investigator: Magdalena Bogun, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

June 26, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT7802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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