Continuous Glucose Monitoring for Diabetic Ketoacidosis

Overseen By Bjorn Westgard, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Acute CHF, Acute MI, CKD stage 4, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Continuous Glucose Monitoring for Diabetic Ketoacidosis?

Research shows that using intermittently scanned continuous glucose monitoring (isCGM) can reduce severe low blood sugar events and diabetic ketoacidosis in adults with type 1 diabetes. Additionally, continuous glucose monitoring helps improve overall diabetes control in both type 1 and type 2 diabetes. ^{1 2 3 4 5}

Is continuous glucose monitoring (CGM) safe for humans?

Continuous glucose monitoring (CGM) is generally considered safe for humans. Studies have shown that CGM can help improve blood sugar control without increasing the risk of low blood sugar episodes, and it is used by people with diabetes to monitor their glucose levels continuously. ^{3 6 7 8 9}

How does continuous glucose monitoring differ from other treatments for diabetic ketoacidosis?

Continuous glucose monitoring (CGM) is unique because it provides real-time tracking of glucose levels, allowing for immediate detection of dangerous changes, unlike traditional methods that rely on periodic blood tests. This continuous data can help prevent severe complications by alerting users to rapid glucose changes, which is particularly useful in managing diabetic ketoacidosis. ^{3 8 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with mild to moderate diabetic ketoacidosis, a serious diabetes complication. Participants should have stable vital signs and be able to give informed consent. Details on who can't join are not provided.

Inclusion Criteria

I have been diagnosed with DKA or HHS and my doctor has decided to start insulin treatment.

Presents at Regions Hospital ED including transfers from other hospitals

pH ≥ 7.1

Exclusion Criteria

I am under 18 years old.

I do not have severe heart, kidney, liver issues, am not pregnant, and can consent for myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive CGM devices and are monitored for glucose levels using the new subcutaneous insulin protocol

4 days

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• CGM

Trial Overview The study tests the use of Continuous Glucose Monitoring (CGM) systems that alert patients about their blood sugar levels during treatment for diabetic ketoacidosis in a hospital setting.

Participant Groups

Group I: CGM with alerts Experimental Treatment 1 Intervention

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 II: CGM without alerts Active Control 1 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 Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Findings from Research

The Eversense continuous glucose monitoring (CGM) system showed a mean absolute relative difference (MARD) of 8.8% compared to reference glucose measurements, significantly surpassing the accuracy goal of 20%, indicating its effectiveness in monitoring glucose levels in individuals with type 1 and type 2 diabetes.

The study, involving 90 participants over 90 days, reported a favorable safety profile with only one serious adverse event (1.1%) related to sensor removal, and 91% of sensors remained functional throughout the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Christiansen, MP., Klaff, LJ., Brazg, R., et al.[2019]

The study involved 12 patients with Type 1 diabetes and demonstrated that continuous glucose monitoring devices (CGMS) accurately tracked blood glucose levels during ketoacidosis, showing excellent agreement with laboratory methods.

As blood glucose levels rose significantly, the CGMS effectively monitored the development of ketosis, confirming its reliability in critical conditions associated with Type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the continuous glucose monitoring system (CGMS) during development of ketosis in patients on insulin pump therapy. Pfützner, J., Forst, T., Butzer, R., et al.[2011]

In a study of 104 adults with type 1 diabetes, those using intermittently scanned continuous glucose monitoring (isCGM) showed a significant reduction in HbA1c levels after 24 weeks compared to those using traditional blood glucose monitoring (BGM), with a difference of 0.3%.

The isCGM group also experienced a greater increase in time-in-range for blood glucose levels and a reduction in time spent in hyperglycemia, indicating improved glycaemic control overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. Yan, J., Zhou, Y., Zheng, X., et al.[2023]

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring for diabetes: potential pitfalls for the general physician. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Performance of the continuous glucose monitoring system (CGMS) during development of ketosis in patients on insulin pump therapy. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

The use of isCGM leads to marked reduction in severe hypoglycemia requiring emergency medical service or hospital admission and diabetic ketoacidosis in adult type 1 diabetes patients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Frequent and Persistent Use of Continuous Glucose Monitoring (CGM) on Hypoglycemia Fear, Frequency of Emergency Medical Treatment, and SMBG Frequency After One Year. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

DKA Prevention and Insulin Pumps: Lessons Learned From a Large Pediatric Pump Practice. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring systems for type 1 diabetes mellitus. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of CGMS during rapid blood glucose changes in patients with type 1 diabetes. [2011]

12. United States pubmed.ncbi.nlm.nih.gov

The continuous glucose monitoring system is useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 diabetes but is not better than frequent capillary glucose measurements for improving metabolic control. [2022]