Diabetic KetoacidosisNCT05439928
Remote Glucose Monitoring System in Hospitalized Patients With Diabetic Ketoacidosis (DKA)
A study testing DEXCOM G6 CGM in people with Diabetic Ketoacidosis, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- DEXCOM G6 CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- AG>20 mEq/L
- Bicarbonate <15mEq/L
- Positive urine ketones or beta hydroxybutyrate >0.3 mmol/L
Who cannot join
- Hypotension (Blood Pressure below 80/60 mmHg)
- Requirement for pressor therapy
- Contraindication for utilizing Dexcom CGM
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital/ Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Remote Glucose Monitoring Using the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Hospitalized Patients With Diabetic Ketoacidosis (DKA)
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.
Read the 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.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- DEXCOM G6 CGM
- Keywords
- Continuous Glucose Monitoring, Diabetes, Hospitalized patients
- Medical subject headings
- Diabetic Ketoacidosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXCOM G6 CGMDevice
Continuous glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| DEXCOM G6 CGM | Experimental | 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. Receives: Device: DEXCOM G6 CGM |
| Hourly Finger Stick Point of Care (Historical Control) | No intervention | DKA patients that received hourly glucose monitoring by finger stick while triaged through the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 days
Secondary outcomes (3)
Length of ICU Stay
Length of ICU stay measured in days
Measured: Up to 20 days
Length of Hospital Stay
Length of hospital stay measured in hours
Measured: 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.
Measured: Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start7 Jun 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Magdalena M. Bogun, MD, Columbia University
- Investigators
- Magdalena Bogun, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439928
- Sponsor's protocol ID
- AAAT7802
- Status last verified
- Apr 2025
- First submitted
- 26 Jun 2022
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther. 2010 Sep;12(9):679-84. doi: 10.1089/dia.2010.0015.
PubMed 20799388Nair BG, Dellinger EP, Flum DR, Rooke GA, Hirsch IB. A Pilot Study of the Feasibility and Accuracy of Inpatient Continuous Glucose Monitoring. Diabetes Care. 2020 Nov;43(11):e168-e169. doi: 10.2337/dc20-0670. Epub 2020 May 11. No abstract available.
PubMed 32393587Pasquel FJ, Umpierrez GE. Individualizing Inpatient Diabetes Management During the Coronavirus Disease 2019 Pandemic. J Diabetes Sci Technol. 2020 Jul;14(4):705-707. doi: 10.1177/1932296820923045. Epub 2020 May 5.
PubMed 32370606Chow KW, Kelly DJ, Rieff MC, Skala PA, Kravets I, Charitou MM, Morley EJ, Gupta R, Miller JD. Outcomes and Healthcare Provider Perceptions of Real-Time Continuous Glucose Monitoring (rtCGM) in Patients With Diabetes and COVID-19 Admitted to the ICU. J Diabetes Sci Technol. 2021 May;15(3):607-614. doi: 10.1177/1932296820985263. Epub 2021 Jan 12.
PubMed 33435706Davis GM, Galindo RJ, Migdal AL, Umpierrez GE. Diabetes Technology in the Inpatient Setting for Management of Hyperglycemia. Endocrinol Metab Clin North Am. 2020 Mar;49(1):79-93. doi: 10.1016/j.ecl.2019.11.002.
PubMed 31980123Umpierrez GE, Klonoff DC. Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital. Diabetes Care. 2018 Aug;41(8):1579-1589. doi: 10.2337/dci18-0002. Epub 2018 Jun 23.
PubMed 29936424Newton CA, Smiley D, Bode BW, Kitabchi AE, Davidson PC, Jacobs S, Steed RD, Stentz F, Peng L, Mulligan P, Freire AX, Temponi A, Umpierrez GE. A comparison study of continuous insulin infusion protocols in the medical intensive care unit: computer-guided vs. standard column-based algorithms. J Hosp Med. 2010 Oct;5(8):432-7. doi: 10.1002/jhm.816.
PubMed 20945468Pal R, Banerjee M, Yadav U, Bhattacharjee S. Clinical profile and outcomes in COVID-19 patients with diabetic ketoacidosis: A systematic review of literature. Diabetes Metab Syndr. 2020 Nov-Dec;14(6):1563-1569. doi: 10.1016/j.dsx.2020.08.015. Epub 2020 Aug 18.
PubMed 32853901Li J, Wang X, Chen J, Zuo X, Zhang H, Deng A. COVID-19 infection may cause ketosis and ketoacidosis. Diabetes Obes Metab. 2020 Oct;22(10):1935-1941. doi: 10.1111/dom.14057. Epub 2020 May 18.
PubMed 32314455Fayfman M, Pasquel FJ, Umpierrez GE. Management of Hyperglycemic Crises: Diabetic Ketoacidosis and Hyperglycemic Hyperosmolar State. Med Clin North Am. 2017 May;101(3):587-606. doi: 10.1016/j.mcna.2016.12.011.
PubMed 28372715Livingston E, Desai A, Berkwits M. Sourcing Personal Protective Equipment During the COVID-19 Pandemic. JAMA. 2020 May 19;323(19):1912-1914. doi: 10.1001/jama.2020.5317. No abstract available.
PubMed 32221579
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Glucose Monitoring Using the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Hospitalized Patients With Diabetic Ketoacidosis (DKA)
- ClinicalTrials.gov ID
- NCT05439928
- Acronym / sponsor ID
- AAAT7802
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Continuous Glucose Monitoring, Diabetes, Hospitalized patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEXCOM G6 CGM | Experimental | Device: DEXCOM G6 CGMContinuous 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. |
| Hourly Finger Stick Point of Care (Historical Control) | No intervention | –DKA patients that received hourly glucose monitoring by finger stick while triaged through the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- AG>20 mEq/L
- Bicarbonate <15mEq/L
- Positive urine ketones or beta hydroxybutyrate >0.3 mmol/L
Key exclusion criteria (3 listed)
- Hypotension (Blood Pressure below 80/60 mmHg)
- Requirement for pressor therapy
- Contraindication for utilizing Dexcom CGM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXCOM G6 CGMContinuous glucose monitoring | Device | DEXCOM G6 CGM |
Primary outcome
Time to Resolution of Metabolic Acidosis
Time frame: 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.
3 secondary outcomes
Length of ICU Stay
Time frame: Up to 20 days
Length of Hospital Stay
Time frame: Up to 20 days
Number of Hypoglycemic Events
Time frame: Up to 20 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20799388Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther. 2010 Sep;12(9):679-84. doi: 10.1089/dia.2010.0015.
- Background: PubMed 32393587Nair BG, Dellinger EP, Flum DR, Rooke GA, Hirsch IB. A Pilot Study of the Feasibility and Accuracy of Inpatient Continuous Glucose Monitoring. Diabetes Care. 2020 Nov;43(11):e168-e169. doi: 10.2337/dc20-0670. Epub 2020 May 11. No abstract available.
- Background: PubMed 32370606Pasquel FJ, Umpierrez GE. Individualizing Inpatient Diabetes Management During the Coronavirus Disease 2019 Pandemic. J Diabetes Sci Technol. 2020 Jul;14(4):705-707. doi: 10.1177/1932296820923045. Epub 2020 May 5.
- Background: PubMed 33435706Chow KW, Kelly DJ, Rieff MC, Skala PA, Kravets I, Charitou MM, Morley EJ, Gupta R, Miller JD. Outcomes and Healthcare Provider Perceptions of Real-Time Continuous Glucose Monitoring (rtCGM) in Patients With Diabetes and COVID-19 Admitted to the ICU. J Diabetes Sci Technol. 2021 May;15(3):607-614. doi: 10.1177/1932296820985263. Epub 2021 Jan 12.
- Background: PubMed 31980123Davis GM, Galindo RJ, Migdal AL, Umpierrez GE. Diabetes Technology in the Inpatient Setting for Management of Hyperglycemia. Endocrinol Metab Clin North Am. 2020 Mar;49(1):79-93. doi: 10.1016/j.ecl.2019.11.002.
- Background: PubMed 29936424Umpierrez GE, Klonoff DC. Diabetes Technology Update: Use of Insulin Pumps and Continuous Glucose Monitoring in the Hospital. Diabetes Care. 2018 Aug;41(8):1579-1589. doi: 10.2337/dci18-0002. Epub 2018 Jun 23.
- Background: PubMed 20945468Newton CA, Smiley D, Bode BW, Kitabchi AE, Davidson PC, Jacobs S, Steed RD, Stentz F, Peng L, Mulligan P, Freire AX, Temponi A, Umpierrez GE. A comparison study of continuous insulin infusion protocols in the medical intensive care unit: computer-guided vs. standard column-based algorithms. J Hosp Med. 2010 Oct;5(8):432-7. doi: 10.1002/jhm.816.
- Background: PubMed 32853901Pal R, Banerjee M, Yadav U, Bhattacharjee S. Clinical profile and outcomes in COVID-19 patients with diabetic ketoacidosis: A systematic review of literature. Diabetes Metab Syndr. 2020 Nov-Dec;14(6):1563-1569. doi: 10.1016/j.dsx.2020.08.015. Epub 2020 Aug 18.
- Background: PubMed 32314455Li J, Wang X, Chen J, Zuo X, Zhang H, Deng A. COVID-19 infection may cause ketosis and ketoacidosis. Diabetes Obes Metab. 2020 Oct;22(10):1935-1941. doi: 10.1111/dom.14057. Epub 2020 May 18.
- Background: PubMed 28372715Fayfman M, Pasquel FJ, Umpierrez GE. Management of Hyperglycemic Crises: Diabetic Ketoacidosis and Hyperglycemic Hyperosmolar State. Med Clin North Am. 2017 May;101(3):587-606. doi: 10.1016/j.mcna.2016.12.011.
- Background: PubMed 32221579Livingston E, Desai A, Berkwits M. Sourcing Personal Protective Equipment During the COVID-19 Pandemic. JAMA. 2020 May 19;323(19):1912-1914. doi: 10.1001/jama.2020.5317. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Bogun, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEXCOM G6 CGM in people with Diabetic Ketoacidosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of Metabolic Acidosis (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05439928, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.