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

Columbia University logo

Columbia University

Status

Not yet enrolling

Conditions

Diabetic Ketoacidosis

Treatments

Device: DEXCOM G6 CGM

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05439928
AAAT7802

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

98 participants in 2 patient groups

DEXCOM G6 CGM
Experimental group
Description:
Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA
Treatment:
Device: DEXCOM G6 CGM
Hourly Finger Stick Point of Care (Historical Control)
No Intervention group
Description:
Retrospective chart review of DKA patients that received hourly glucose monitoring by finger stick while in the ICU

Trial contacts and locations

1

Loading...

Central trial contact

Marc Probst, MD; Magdalena Bogun, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems