Technology-Based Care for Diabetic Ketoacidosis

(DKA Trial)

Overseen By Amber Sike

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Allergy to CGM, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if continuous glucose monitoring (CGM) can better control blood sugar levels and reduce hospital readmissions for individuals with type 1 diabetes admitted for diabetic ketoacidosis (DKA). The trial will compare the CGM method to the usual care provided to DKA patients. Individuals with type 1 diabetes who have been hospitalized for DKA and have never used CGM before may be suitable candidates, particularly if they have a smartphone compatible with CGM technology. As an unphased trial, this study offers a unique opportunity to explore innovative diabetes management methods and contribute to advancing diabetes care.

Do I need to stop my current medications for this trial?

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

What prior data suggests that continuous glucose monitoring is safe for patients with diabetic ketoacidosis?

Research has shown that continuous glucose monitoring (CGM) serves as a reliable tool for hospitals, particularly during insulin treatment and after resolving diabetic ketoacidosis (DKA). Studies have found that CGM provides accurate blood sugar readings, aiding in the identification of missed opportunities for earlier medical intervention in adults with DKA. Previous patients have demonstrated that CGM is both effective and safe.

These studies indicate that CGM is easy for patients to use. Hospitals already use this technology to help manage diabetes, which supports its safety. No major reports of negative effects have emerged in these situations. Overall, CGM is considered a safe option for monitoring blood sugar levels in similar medical cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Continuous Glucose Monitoring (CGM) for diabetic ketoacidosis because it offers real-time tracking of blood sugar levels, which is a significant improvement over traditional methods that rely on periodic blood tests. Unlike the standard care involving intermittent finger-prick tests, CGM provides continuous data, allowing for quicker adjustments in treatment and potentially reducing the risk of complications. This technology could lead to more personalized and responsive care, making it easier to manage diabetic ketoacidosis effectively.

What evidence suggests that Continuous Glucose Monitoring (CGM) is effective for improving glycemic control in diabetic ketoacidosis?

Research has shown that Continuous Glucose Monitoring (CGM) helps manage blood sugar levels in people with diabetes. In this trial, one group of participants will use CGM during their hospital stay for diabetic ketoacidosis (DKA), while another group will be assessed retrospectively using standard care data. Studies have found CGM reliable for hospital use, especially during and after DKA treatment, a serious diabetes complication. One study found that CGM use reduced DKA hospitalizations by half. Additionally, CGM provides accurate blood sugar readings and helps identify when action is needed. People using CGM have experienced significant and lasting drops in their HbA1c levels, an important measure of long-term blood sugar control. ^{1 6 7 8 9}

Who Is on the Research Team?

Zhou Keren, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who have been admitted for Diabetic Ketoacidosis (DKA). It's designed to test if a new care approach using technology can improve blood sugar control and reduce hospital readmissions.

Inclusion Criteria

Allergy to any component of the CGM

Compatible smart phone with CGM

No prior use of continuous glucose monitoring (CGM)

Exclusion Criteria

Condition which, in investigator judgement would limit their ability to participate safely

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous glucose monitoring (CGM) technology to improve glycemic control

6 months

Regular follow-ups with endocrinology and diabetes care team

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring (CGM)

Trial Overview The study compares the effectiveness of continuous glucose monitoring (CGM) alongside standard diabetes care versus standard care alone in managing DKA in Type 1 Diabetes patients.

How Is the Trial Designed?

Group I: Control Arm - Standard of Care, retrospective Experimental Treatment 1 Intervention

Retrospective data looking at 12 patients undergoing standard of care for diabetic ketoacidosis

Group II: Intervention Arm - Continuous Glucose Monitoring (CGM) Active Control 1 Intervention

12 patients with confirmed diabetic ketoacidosis upon hospital admission will receive continuous glucose monitor (CGM)

Continuous Glucose Monitoring (CGM) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes
• Gestational diabetes
• Hypoglycemia unawareness
• High glycemic variability

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes
• Gestational diabetes
• Hypoglycemia unawareness
• High glycemic variability

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes
• Gestational diabetes
• Hypoglycemia unawareness
• High glycemic variability

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study of 35 children with diabetic ketoacidosis (DKA), real-time continuous glucose monitoring (rtCGM) was found to be highly accurate, with 95.4% of glucose readings falling within clinically acceptable ranges compared to point-of-care capillary and serum glucose values.

The use of rtCGM in treating pediatric DKA was deemed feasible and reliable, with an average hospital stay of just 1.32 days, indicating its potential to improve glycemic control in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Pediatric Diabetic Ketoacidosis. Pott, T., Jimenez-Vega, J., Parker, J., et al.[2022]

In a study of 40 adults with type 1 diabetes at high risk for hypoglycemia, real-time continuous glucose monitoring (rtCGM) significantly reduced glycemic variability measures associated with hypoglycemia compared to intermittently scanned continuous glucose monitoring (iscCGM) after eight weeks.

Participants who switched from iscCGM to rtCGM after 16 weeks showed notable improvements in hypoglycemia risk measures, indicating that rtCGM may be more effective in managing glycemic variability in high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes. Avari, P., Moscardo, V., Jugnee, N., et al.[2021]

Real-time continuous glucose monitoring (rtCGM) systems provide automatic glucose data transmission, alerts, and alarms, making them more user-friendly and responsive compared to intermittently scanned (isCGM) systems, which require manual scanning for data retrieval.

Both rtCGM and isCGM offer significant advantages over traditional blood glucose self-monitoring, but the choice between them should be based on individual patient needs and preferences due to their differing features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. Edelman, SV., Argento, NB., Pettus, J., et al.[2019]

In a study of 112 pediatric patients with type 1 diabetes, those using real-time continuous glucose monitoring (rtCGM) achieved significantly better glycemic control, spending more time in the target glucose range (57.7% vs 52.3%) and less time below the target range (4.3% vs 10.2%) compared to those using intermittently scanned CGM (isCGM).

Despite the differences in time in range and time below range, there was no significant difference in the overall glycosylated hemoglobin A1c levels between the two groups, suggesting that while rtCGM may improve daily glucose management, it does not necessarily lead to lower long-term average blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the clinical effects of intermittently scanned and real-time continuous glucose monitoring in children and adolescents with type 1 diabetes: A retrospective cohort study. Urakami, T., Terada, H., Yoshida, K., et al.[2022]

In a study of 18 pediatric patients with diabetic ketoacidosis (DKA), three continuous glucose monitoring (CGM) devices demonstrated satisfactory clinical accuracy, with the overall mean absolute relative difference (MARD) being 13.02%.

The accuracy of CGM devices was significantly affected by the severity of DKA, particularly during the initial days in the pediatric intensive care unit, with lower accuracy linked to lower serum bicarbonate levels, indicating that acidosis may impact CGM performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Use of Continuous Glucose Monitoring in Critically Ill Pediatric Patients with Diabetic Ketoacidosis. Park, E., Kim, M.[2023]

In a study involving 122 critically ill patients, the intermittently scanned continuous glucose monitoring (isCGM) system showed an overall mean absolute relative difference (MARD) of 18.0%, indicating suboptimal accuracy, especially with a higher MARD of 33.1% in hypoglycemic ranges.

Despite the accuracy concerns, clinical assessments revealed that 98.5% of glucose values were classified as clinically acceptable, suggesting that while isCGM may not be perfectly accurate, it could still provide useful information for managing glucose levels in ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of the intermittently scanned continuous glucose monitoring system in critically ill patients: a prospective, multicenter, observational study. Huang, W., Li, S., Lu, J., et al.[2022]

Continuous glucose monitoring (CGM) is becoming a standard tool for managing type 1 diabetes, with advancements that may lead to its integration into closed-loop artificial beta-cell systems.

The review highlights the accuracy and performance of the two currently approved CGM devices, discussing their clinical trial results, limitations, and best practices for use in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Weinzimer, SA., Tamborlane, WV., Chase, HP., 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]

Continuous Glucose Monitoring (CGM) devices, including real-time (rtCGM) and intermittently scanned (isCGM), significantly improve glucose control and reduce hypoglycemia in insulin-treated individuals with diabetes, based on recent clinical evidence.

An updated algorithm was developed to help healthcare providers choose the most suitable CGM device for different clinical scenarios, such as type 1 and type 2 diabetes, pregnancy, and frailty, ensuring a personalized approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. Maiorino, MI., Buzzetti, R., Irace, C., et al.[2023]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11800229/

Continuous Glucose Monitoring in Hospitalized Adults With ... Our study indicates that CGM technology is a reliable tool for hospital use during acute insulin treatment and after the resolution of DKA.

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

Intermittently scanned continuous glucose monitoring ... The implementation of isCGM led to a 50% reduction in DKA hospitalization rates. · This reduction was specially associated with higher isCGM adherence and older ...

3. chestcc.org chestcc.org/article/S2949-7884(24)00063-7/fulltext

Analytical Accuracy of a Continuous Glucose Monitor in ... In this study, CGM provided accurate measurements of blood glucose and identified missed opportunities for earlier intervention in adults with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9233597/

Effect of Different Glucose Monitoring Methods on Bold ... Meta-analysis results showed that continuous blood glucose monitoring (CGM) could significantly reduce the HbA1c level of patients, weighted mean difference ( ...

5. e-dmj.org e-dmj.org/journal/view.php?number=2924

Comparison of Real-Time and Intermittently-Scanned ... Overall, a significant reduction in HbA1c level was observed after 3 months of CGM, and the effect was sustained for 2 years. The mean HbA1c ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2949788424000637

Analytical Accuracy of a Continuous Glucose Monitor in ... In this study, CGM provided accurate measurements of blood glucose and identified missed opportunities for earlier intervention in adults with DKA. Future ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05439928

NCT05439928 | Remote Glucose Monitoring System in ... The purpose of this research study is to investigate the use of continuous glucose monitoring (CGM) device DEXCOM G6 in non-critically patients treated for ...

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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.

9. liebertpub.com liebertpub.com/doi/10.1089/dia.2024.0628

The Association of Continuous Glucose Monitoring Metrics ... We investigated the association between continuous glucose monitoring (CGM) metrics and clinical outcomes in the nonintensive care unit (non-ICU) setting.