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

12 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Technology-Based Care for Diabetic Ketoacidosis?

Research shows that using real-time continuous glucose monitoring (rtCGM) can improve blood sugar control and reduce the risk of diabetic ketoacidosis (DKA) in people with type 1 diabetes. This suggests that similar technology-based treatments could be effective in managing DKA. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitoring (CGM) systems, including real-time (rtCGM) and intermittently scanned (isCGM), have been used safely in adults and children with type 1 diabetes to help manage blood sugar levels. These systems are generally considered safe, but their use in specific conditions like diabetic ketoacidosis (DKA) in children has not been well studied. ^{1 2 6 7 8}

How does Continuous Glucose Monitoring (CGM) differ from other treatments for diabetic ketoacidosis?

Continuous Glucose Monitoring (CGM) is unique because it provides real-time or intermittently scanned glucose data, allowing for continuous tracking of blood sugar levels, which can help prevent diabetic ketoacidosis (DKA) by alerting users to dangerous glucose trends. Unlike traditional methods that require manual blood sugar checks, CGM offers a more proactive approach to managing diabetes, although its accuracy can be affected during severe DKA episodes. ^{1 3 7 9 10}

What is the purpose of this trial?

The study team proposes that use of a novel multi-disciplinary approach with continuous glucose monitoring technology can significantly improve glycemic control and reduce readmissions among those with type 1 diabetes mellitus (T1DM) admitted for Diabetic ketoacidosis (DKA). This will also help promote a pathway for care of these patients after admission utilizing resources which are available within the Endocrinology, Diabetes and Metabolism department at the Cleveland Clinic.

Research Team

Zhou Keren, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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]

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]

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 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]

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]

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]

References

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

Continuous Glucose Monitoring in Pediatric Diabetic Ketoacidosis. [2022]

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

Accuracy of the intermittently scanned continuous glucose monitoring system in critically ill patients: a prospective, multicenter, observational study. [2022]

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

Continuous glucose monitoring in type 1 diabetes. [2019]

5. 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]

6. Japan 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. [2022]

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

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. [2019]

8. United States 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. [2021]

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

Clinical Use of Continuous Glucose Monitoring in Critically Ill Pediatric Patients with Diabetic Ketoacidosis. [2023]

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

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]