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

Not Applicable

Completed

Conditions: Diabetic Ketoacidosis

Interventions: Device: DEXCOM G6 CGM

Registration Number: NCT05439928

Lead Sponsor: Columbia University

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 163

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXCOM G6 CGM	DEXCOM G6 CGM	Continuous glucose monitoring by DEXCOM G6 (glucose monitoring device) in a step-down unit in participants with DKA

Primary Outcome Measures

Name	Time	Method
Time to Resolution of Metabolic Acidosis	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.

Secondary Outcome Measures

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