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

March 9, 2026 updated by: HealthPartners Institute

The Use of Continuous Glucose Monitoring With Patients Undergoing a New Subcutaneous Insulin Protocol for Mild to Moderate Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic State

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
Time Frame: Duration of hospital stay from admission to discharge (average of 4 days).
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 Frame: From time of admission until the time of first insulin administration by CGM (average of 2 hours).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate patient safety and care outcomes related to use of CGM during hospitalization
Time Frame: Duration of hospital stay from admission to discharge (average of 4 days).
Length of hospital stay (ED, ICU, and/or Non-ICU)
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
Time Frame: From admission to medical clearance for discharge or transfer to another healthcare facility, whichever comes first (average of 4 days).
Time until DKA/HHS resolution
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
Time Frame: Duration of hospital stay from admission to discharge (average of 4 days).

Hits: how often does CGM device alert to glucose levels that are confirmed by FSBG to require intervention?

Misses: how often does FSBG identify glucose levels that require intervention when CGM does not alert?

False alarms: how often does CGM device alert when FSBG suggests no intervention is necessary?

Nurse acceptability of CGM use:

The investigators seek to measure care team acceptability of CGM during the treatment of patients with DKA/HHS by comparing their survey responses in reference to caring for patients who have CGM devices with alerts (Experimental group) vs patients who have CGM devices without alerts (Control group).
Duration of hospital stay from admission to discharge (average of 4 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A24-338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared to for HIPAA considerations and data is only to be used for measurement of site-specific protocols.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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