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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetic Ketoacidosis

Intervention / Treatment
-----------------
* Device: DEXCOM G6 CGM


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous Glucose Monitoring, Diabetes, Hospitalized patients