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

NCT ID: NCT06693115

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-05-31

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.

Detailed Description

Diabetic ketoacidosis (DKA) and Hyperosmolar Hyperglycemic State (HHS) are severe complications of diabetes mellitus and one of the most common causes of hospital admission among people with diabetes. Up to now, the standard of care for managing DKA and HHS at Regions Hospital has involved intravenous (IV) insulin to treat hyperglycemia. However, the use of IV insulin is associated with increased care team resource utilization and the potential for adverse events such as hypoglycemia. Regions Hospital is in the process of implementing a new subcutaneous (subQ) insulin protocol, which has the potential to reduce resource utilization and improve patient safety, while producing similar outcomes for patients. One critical part of the new protocol is reducing the frequency of point of care capillary blood glucose monitoring, commonly known as a Finger Stick Blood Glucose test (FSBG) from hourly (Q1) to every 4 hours (Q4). The use of subQ insulin with less frequent blood sugar monitoring is possible owing to subQ insulin's slower mechanism of action than the IV insulin. Protocols have been shown to be safe within other hospital systems. However, the change from Q1 to Q4 monitoring of blood sugars does lead to some concern on the part of providers about correcting hyperglycemia too slowly or failing to recognize impending hypoglycemic events.

The use of Continuous Glucose Monitoring (CGM) technology has been proposed to provide continuous (i.e. every 5 mins) updates about patient glucose levels in between FSBG checks in patients being treated for mild to moderate DKA or HHS. This continuous monitoring would help provide prompt identification of hypoglycemic episodes and improve safety during hospitalization, a change that could provide peace of mind to care providers and patients as the change is made from Q1 to Q4 FSBG.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

CGM with alerts

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.

Group Type: EXPERIMENTAL

CGM with alerts

Intervention Type: 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 without alerts

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CGM with alerts

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Central Contacts

Bjorn Westgard, MD

Role: CONTACT

Bjorn.C.Westgard@HealthPartners.com

651-254-6953

Facility Contacts

Study Team Coordinator

Role: primary

Kirsten.A.Dalrymple@HealthPartners.com

651-254-5316

References

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.

Reference Type: BACKGROUND

PMID: 27286715 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37155338 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28965029 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33515756 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37578799 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35128974 (View on PubMed)

Other Identifiers

A24-338

Identifier Type: -

Identifier Source: org_study_id