Diabetic KetoacidosisNCT06693115
Continuous Glucose Monitoring Using a New Subcutaneous Insulin Protocol for Mild to Moderate Diabetic Ketoacidosis
A study testing CGM with alerts in people with Diabetic Ketoacidosis and Hyperglycemia, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ketoacidosis, Hyperglycemia
- What is being tested?
- CGM with alerts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy
- Severe sepsis or septic shock
- AMS > if patient cannot consent
- Euglycemic DKA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- CGM with alerts
- Medical subject headings
- Diabetic Ketoacidosis, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM with alertsDevice
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:
- 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)
- CGM alerts to interstitial glucose level of 150 mg/dL or less.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia
Recruitment, overall participation, and completion rate.
Measured: 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).
Measured: 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
Length of hospital stay (ED, ICU, and/or Non-ICU)
Measured: 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 until DKA/HHS resolution
Measured: 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
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).
Measured: Duration of hospital stay from admission to discharge (average of 4 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study startJan 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: The trial was deemed to be unfeasible to commence at this site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693115
- Sponsor's protocol ID
- A24-338
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared to for HIPAA considerations and data is only to be used for measurement of site-specific protocols.
Publications
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.
PubMed 27286715Park 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.
PubMed 37155338Klonoff 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.
PubMed 28965029Faulds 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.
PubMed 33515756Zelada 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.
PubMed 37578799Wright 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.
PubMed 35128974
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Continuous Glucose Monitoring With Patients Undergoing a New Subcutaneous Insulin Protocol for Mild to Moderate Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic State
- ClinicalTrials.gov ID
- NCT06693115
- Acronym / sponsor ID
- A24-338
- Conditions
- Diabetic Ketoacidosis, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was deemed to be unfeasible to commence at this site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM with alerts | Experimental | Device: CGM with alertsThe 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| CGM with alertsCGM 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. | Device | CGM with alerts |
Primary outcome
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.
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).
3 secondary outcomes
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).
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).
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 27286715Wallia 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.
- Background: PubMed 37155338Park 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.
- Background: PubMed 28965029Klonoff 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.
- Background: PubMed 33515756Faulds 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.
- Background: PubMed 37578799Zelada 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.
- Background: PubMed 35128974Wright 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.
- Individual participant dataSharing planned: No. IPD will not be shared to for HIPAA considerations and data is only to be used for measurement of site-specific protocols.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM with alerts in people with Diabetic Ketoacidosis and Hyperglycemia, run by HealthPartners Institute 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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 11 Mar 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
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).). The study lists 2 primary outcomes in all. 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 NCT06693115, which also lists 6 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 11 Mar 2026.