Diabetic Ketoacidosis
Conditions
Keywords
Continuous Glucose Monitoring, Diabetes, Hospitalized patients
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.
Interventions
DEVICEDEXCOM G6 CGM
Continuous glucose monitoring
Sponsors
DexCom, Inc.
Columbia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost Savings | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| Hourly Finger Stick Point of Care (Historical Control) DKA patients that received hourly glucose monitoring by finger stick while triaged to the ICU. | 119 |
| Total | 163 |
Baseline characteristics
| Characteristic | Hourly Finger Stick Point of Care (Historical Control) | Total | DEXCOM G6 CGM |
|---|---|---|---|
| Age, Continuous | 47.66 years | 49.26 years | 53 years |
| Diabetes Type 1 | 42 Participants | 64 Participants | 22 Participants |
| Diabetes Type 2 | 74 Participants | 96 Participants | 22 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 119 participants | 163 participants | 44 participants |
| Sex: Female, Male Female | 56 Participants | 75 Participants | 19 Participants |
| Sex: Female, Male Male | 63 Participants | 88 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 119 |
| other Total, other adverse events | 0 / 44 | 3 / 119 |
| serious Total, serious adverse events | 0 / 44 | 0 / 119 |
Outcome results
Primary
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.
Time frame: Up to 10 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DEXCOM G6 CGM | Time to Resolution of Metabolic Acidosis | 12.84 hours |
| Hourly Finger Stick Point of Care (Historical Control) | Time to Resolution of Metabolic Acidosis | 12.02 hours |
Secondary
Length of Hospital Stay
Length of hospital stay measured in hours
Time frame: Up to 20 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DEXCOM G6 CGM | Length of Hospital Stay | 120 hours |
| Hourly Finger Stick Point of Care (Historical Control) | Length of Hospital Stay | 99.08 hours |
Secondary
Length of ICU Stay
Length of ICU stay measured in days
Time frame: Up to 20 days
Population: 60 participants in the Control group stayed in the ICU. No participants from the CGM group stayed in the ICU.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hourly Finger Stick Point of Care (Historical Control) | Length of ICU Stay | 28.47 hours |
Secondary
Number of Hypoglycemic Events
The number of hypoglycemic events will be recorded. A hypoglycemic event is defined as glucose level \<70 mg/dL.
Time frame: Up to 20 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEXCOM G6 CGM | Number of Hypoglycemic Events | 0 hypoglycemic events |
| Hourly Finger Stick Point of Care (Historical Control) | Number of Hypoglycemic Events | 3 hypoglycemic events |
Other Pre-specified
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.
Time frame: Up to 20 days
Population: Data was not collected