Continuous Glucose Monitoring Using a New Subcutaneous Insulin Protocol for Mild to Moderate Diabetic Ketoacidosis

NCT06693115 | Withdrawn FDA Device

• 1 other identifier: A24-338
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Using a prospective, mixed methods study design, the investigators will assess the feasibility, usefulness, and care team acceptability of CGM in conjunction with FSBG during implementation of the new subQ DKA/HHS protocol at Regions Hospital. This will include evaluating how many patients agree to have a CGM device placed, time to place the CGM devices, CGM impact on length of stay, level of care required, frequency of alerts to changing glucose levels events, and assessing the match between CGM and FSBG readings done in the inpatient setting. Results will help inform cost effective, safe, patient-centered strategies, while gauging care team satisfaction to optimize DKA and HHS management in the future.

Conditions

Diabetic Ketoacidosis; Hyperglycemia

Outcome Measures

Primary Outcomes (2)

• Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia

  Recruitment, overall participation, and completion rate.

  Duration of hospital stay from admission to discharge (average of 4 days).

• Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia

  Time to place CGM (time from admission, time from insulin administration).

  From time of admission until the time of first insulin administration by CGM (average of 2 hours).

Secondary Outcomes (3)

• Evaluate patient safety and care outcomes related to use of CGM during hospitalization

  Duration of hospital stay from admission to discharge (average of 4 days).

• Evaluate patient safety and care outcomes related to use of CGM during hospitalization

  From admission to medical clearance for discharge or transfer to another healthcare facility, whichever comes first (average of 4 days).

• Describe accuracy and usefulness of CGM for monitoring resolution from hyperglycemia

  Duration of hospital stay from admission to discharge (average of 4 days).

Study Arms (2)

CGM with alerts

EXPERIMENTAL

The experimental group will have a Dexcom 7 CGM placed by a trained and credentialed member of the research team, or by a trained care team member (e.g. nurse, physician, diabetes educator). CGM devices will be set to alert the care team when interstitial glucose levels hit 250 mg/dL and 150 mg/dL. Dexcom 7s automatically alert when glucose levels are 55 mg/dL or lower. Nurses will be instructed to check the glucose trends on the CGM device when alerted. They will be asked to check glucose levels with a FSBG according to the following instructions: 1. CGM alerts to interstitial glucose level of 250 mg/dL AND trend indicates rapidly decreasing glucose levels 2. CGM alerts to interstitial glucose level of 150 mg/dL or less.

Device: CGM with alerts

CGM without alerts

NO INTERVENTION

The control group will have a Dexcom 7 CGM placed by a trained and credentialed member of the research team, or by a trained care team member (e.g. nurse, physician, diabetes educator). The control group will have the device placed and glucose levels will be collected, but the device will not be set to alert (though note that the Dexcom 7 CGM will always alert when glucose drops below 55 mg/dl, so this alert will exist for both groups).

Interventions

CGM with alerts DEVICE

CGM devices will be set to alert the care team when interstitial glucose levels hit 250 mg/dL and 150 mg/dL. Dexcom 7s automatically alert when glucose levels are 55 mg/dL or lower. Nurses will be instructed to check the glucose trends on the CGM device when alerted. They will be asked to check glucose levels with a FSBG according to the following instructions: 1. CGM alerts to interstitial glucose level of 250 mg/dL AND trend indicates rapidly decreasing glucose levels (indicated by double down arrow on Dexcom 7) 2. CGM alerts to interstitial glucose level of 150 mg/dL or less.

CGM with alerts

Eligibility Criteria

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

You may qualify if:

• years or older
• Presents at Regions Hospital ED including transfers from other hospitals
• Meets criteria for new subQ insulin protocol:
• Diagnosis of DKA or HHS (hyperosmolar hyperglycemic state) and provider decision to initiate insulin
• pH ≥ 7.1
• HCO3 ≥ 12

You may not qualify if:

• Under 18 years of age
• Excluded from new subQ protocol, specifically:
• Acute CHF exacerbation
• Acute MI (ACS/NSTEMI type 1 not demand ischemia)
• CKD stage 4 or AKI with creatinine \> 3
• ESLD
• Pregnancy
• Severe sepsis or septic shock
• AMS \> if patient cannot consent
• Euglycemic DKA

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (6)

• Wallia A, Umpierrez GE, Nasraway SA, Klonoff DC; PRIDE Investigators. Round Table Discussion on Inpatient Use of Continuous Glucose Monitoring at the International Hospital Diabetes Meeting. J Diabetes Sci Technol. 2016 Aug 22;10(5):1174-81. doi: 10.1177/1932296816656380. Print 2016 Sep.

  PMID: 27286715 BACKGROUND

• Park E, Kim M. Clinical Use of Continuous Glucose Monitoring in Critically Ill Pediatric Patients with Diabetic Ketoacidosis. Diabetes Technol Ther. 2023 Aug;25(8):529-537. doi: 10.1089/dia.2023.0012. Epub 2023 Jul 17.

  PMID: 37155338 BACKGROUND

• Klonoff DC, Ahn D, Drincic A. Continuous glucose monitoring: A review of the technology and clinical use. Diabetes Res Clin Pract. 2017 Nov;133:178-192. doi: 10.1016/j.diabres.2017.08.005. Epub 2017 Sep 1.

  PMID: 28965029 BACKGROUND

• Faulds ER, Jones L, McNett M, Smetana KS, May CC, Sumner L, Buschur E, Exline M, Ringel MD, Dungan K. Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring (CGM) in Critically Ill Patients With COVID-19. Endocr Pract. 2021 Apr;27(4):354-361. doi: 10.1016/j.eprac.2021.01.011. Epub 2021 Jan 27.

  PMID: 33515756 BACKGROUND

• Zelada H, Perez-Guzman MC, Chernavvsky DR, Galindo RJ. Continuous glucose monitoring for inpatient diabetes management: an update on current evidence and practice. Endocr Connect. 2023 Sep 25;12(10):e230180. doi: 10.1530/EC-23-0180. Print 2023 Oct 1.

  PMID: 37578799 BACKGROUND

• Wright JJ, Williams AJ, Friedman SB, Weaver RG, Williams JM, Hodge E, Fowler M, Bao S. Accuracy of Continuous Glucose Monitors for Inpatient Diabetes Management. J Diabetes Sci Technol. 2023 Sep;17(5):1252-1255. doi: 10.1177/19322968221076562. Epub 2022 Feb 7.

  PMID: 35128974 BACKGROUND

MeSH Terms

Conditions

Diabetic Ketoacidosis; Hyperglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)