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

NCT05439928 | Completed Results FDA Device

• 1 other identifier: AAAT7802
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Ketoacidosis

Keywords

Continuous Glucose Monitoring; Diabetes; Hospitalized patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of ICU Stay

  Up to 20 days

• Length of Hospital Stay

  Up to 20 days

• Number of Hypoglycemic Events

  Up to 20 days

Other Outcomes (1)

• Cost Savings

  Up to 20 days

Study Arms (2)

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.

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

Interventions

DEXCOM G6 CGM DEVICE

Continuous glucose monitoring

DEXCOM G6 CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• AG\>20 mEq/L
• Bicarbonate \<15mEq/L
• Positive urine ketones or beta hydroxybutyrate \>0.3 mmol/L

You may not qualify if:

• Hypotension (Blood Pressure below 80/60 mmHg)
• Requirement for pressor therapy
• Contraindication for utilizing Dexcom CGM

Sponsors & Collaborators

• Columbia University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

New York Presbyterian Hospital/ Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (11)

• 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.

  PMID: 20799388 BACKGROUND

• Nair 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.

  PMID: 32393587 BACKGROUND

• Pasquel 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.

  PMID: 32370606 BACKGROUND

• Chow 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.

  PMID: 33435706 BACKGROUND

• Davis 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.

  PMID: 31980123 BACKGROUND

• Umpierrez 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.

  PMID: 29936424 BACKGROUND

• Newton 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.

  PMID: 20945468 BACKGROUND

• Pal 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.

  PMID: 32853901 BACKGROUND

• Li 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.

  PMID: 32314455 BACKGROUND

• Fayfman 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.

  PMID: 28372715 BACKGROUND

• Livingston 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.

  PMID: 32221579 BACKGROUND

MeSH Terms

Conditions

Diabetic Ketoacidosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders

Results Point of Contact

• Title: Magdalena Bogun, MD
• Organization: Columbia University

mmb2263@cumc.columbia.edu

2128515494

Study Officials

• Magdalena Bogun, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: June 30, 2022
• Study Start: June 7, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)