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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the usefulness and safety of continuous glucose monitors (CGMs) for individuals with diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in a hospital setting. Researchers aim to determine if CGMs can assist doctors and nurses in better managing blood sugar levels and reducing hospital stay durations. The trial includes two main groups: one where the CGM alerts the care team to significant blood sugar changes and one without these alerts. Individuals recently diagnosed with DKA or HHS and beginning insulin treatment might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance hospital care for others.

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 prior data suggests that continuous glucose monitoring is safe for diabetic ketoacidosis management?

Research has shown that continuous glucose monitoring (CGM) devices, such as the Dexcom 7 used in this study, are generally safe for people with diabetes. Studies have found that CGM can help manage blood sugar levels by providing real-time information and alerts, helping individuals avoid dangerous high and low blood sugar levels.

In previous research, individuals using CGM with alerts experienced fewer diabetes-related problems. The devices are easy to use, and most users report satisfaction. Although minor side effects like skin irritation at the sensor site can occur, serious issues are rare.

The Dexcom 7 device in this trial includes alerts for low blood sugar, helping to prevent severe drops. Overall, CGM is a reliable tool for managing diabetes, with a strong safety record in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because continuous glucose monitoring (CGM) for diabetic ketoacidosis (DKA) could revolutionize how we manage this serious condition. Unlike traditional methods that rely on intermittent fingerstick blood glucose checks, CGM provides continuous, real-time data on glucose levels. This trial explores the potential of CGM with alert systems set to notify caregivers when glucose levels hit specific thresholds, allowing for more timely interventions. By potentially catching dangerous glucose level changes earlier, CGM could improve outcomes and reduce the risk of complications from DKA.

What evidence suggests that Continuous Glucose Monitoring is effective for managing Diabetic Ketoacidosis?

Studies have shown that Continuous Glucose Monitoring (CGM) with alerts can help people manage their blood sugar more effectively. In this trial, one group will use CGM with alerts, which research indicates can significantly reduce the risk of hospital visits for people with diabetes. This system alerts the care team when blood sugar levels are too high or too low, allowing for quick action to prevent complications. Users of CGM with alerts have experienced better overall blood sugar control. This makes CGM with alerts a promising tool for managing conditions like diabetic ketoacidosis (DKA), where maintaining stable blood sugar is crucial. Another group in this trial will use CGM without alerts, serving as a control to evaluate the alert system's effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

pH ≥ 7.1

Presents at Regions Hospital ED including transfers from other hospitals

HCO3 ≥ 12

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822725003869

Intermittently scanned continuous glucose monitoring ... This study analyzed the impact of implementing intermittently scanned continuous glucose monitoring (isCGM) on hospitalization rates for diabetic ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2205650

Intermittently Scanned Continuous Glucose Monitoring for ... The use of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels resulted in significantly lower ...

3. diabetesresearchclinicalpractice.com diabetesresearchclinicalpractice.com/article/S0168-8227(25)00386-9/abstract

Intermittently scanned continuous glucose monitoring ... This study analyzed the impact of implementing intermittently scanned continuous glucose monitoring (isCGM) on hospitalization rates for diabetic ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603287/

Intermittently Scanned and Real-Time Continuous Glucose ... The aim of this report is to summarize the evidence regarding the comparative clinical effectiveness of monitoring glycemia with isCGM versus rtCGM in people ...

5. e-dmj.org e-dmj.org/journal/view.php?doi=10.4093/dmj.2024.0160

Comparison of Real-Time and Intermittently-Scanned ... This study compares the association between real-time continuous glucose monitoring (rtCGM) and intermittently-scanned CGM (isCGM) and glycemic control in ...

6. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ... Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2530016423000174

To evaluate the use and clinical effect of intermittently ... To evaluate the use and clinical effect of intermittently scanned continuous glucose monitoring in adults with type 1 diabetes: Results of a multicentre ...

8. mdpi.com mdpi.com/2077-0383/13/3/642

Effectiveness and Safety of the Intermittently Scanned ... Real-time Continuous Glucose Monitoring (rt-CGM) does not require manual scanning, and it provides predictive alarms for hypo- or hyperglycaemia, thus resulting ...