N/A
N=163
Remote Glucose Monitoring System in Hospitalized Patients With Diabetic Ketoacidosis (DKA)
Diabetic Ketoacidosis
Bottom Line
View on ClinicalTrials.gov: NCT05439928 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Time to Resolution of Metabolic Acidosis — 12.84; 12.02 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DEXCOM G6 CGM (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Resolution of Metabolic Acidosis |
12.84; 12.02 | — |
| SECONDARY Length of ICU Stay |
28.47 | — |
| SECONDARY Length of Hospital Stay |
120; 99.08 | — |
| SECONDARY Number of Hypoglycemic Events |
0; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age >18 years
- AG>20 mEq/L
- Bicarbonate 0.3 mmol/L
Exclusion Criteria
- Hypotension (Blood Pressure below 80/60 mmHg)
- Requirement for pressor therapy
- Contraindication for utilizing Dexcom CGM
Data sourced from ClinicalTrials.gov (NCT05439928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.