12 Participants Needed

Technology-Based Care for Diabetic Ketoacidosis

(DKA Trial)

KJ
AS
Overseen ByAmber Sike
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12678

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.137910

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

ZK

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)
See 2 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Control Arm - Standard of Care, retrospectiveExperimental Treatment1 Intervention
Retrospective data looking at 12 patients undergoing standard of care for diabetic ketoacidosis
Group II: Intervention Arm - Continuous Glucose Monitoring (CGM)Active Control1 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:

πŸ‡ΊπŸ‡Έ
Approved in United States as Continuous Glucose Monitoring for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
  • Hypoglycemia unawareness
  • High glycemic variability
πŸ‡ͺπŸ‡Ί
Approved in European Union as Continuous Glucose Monitoring for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
  • Hypoglycemia unawareness
  • High glycemic variability
πŸ‡¨πŸ‡¦
Approved in Canada as Continuous Glucose Monitoring for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
  • Hypoglycemia unawareness
  • High glycemic variability

Find a Clinic Near You

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

References

Continuous Glucose Monitoring in Pediatric Diabetic Ketoacidosis. [2022]
Accuracy of the intermittently scanned continuous glucose monitoring system in critically ill patients: a prospective, multicenter, observational study. [2022]
Performance of the continuous glucose monitoring system (CGMS) during development of ketosis in patients on insulin pump therapy. [2011]
Continuous glucose monitoring in type 1 diabetes. [2019]
Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. [2023]
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]
Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. [2019]
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]
Clinical Use of Continuous Glucose Monitoring in Critically Ill Pediatric Patients with Diabetic Ketoacidosis. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]
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