NCT06471322

A Multi-Disciplinary Technology-Based Care for Diabetic Ketoacidosis in Patients With Type 1 Diabetes

A Multi-Disciplinary Technology-Based Care After Hospitalization for Diabetic Ketoacidosis in Patients With Type 1 Diabetes

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Diabetic ketoacidosis (DKA) is a serious complication of type 1 diabetes mellitus (T1DM) with significant cost to the United States of $2.2 billion over the past decade. Readmissions are very common with a 20.2% readmission rate within 30 days of discharge and 86% of those admitted with DKA having a subsequent 1-3 admissions in the following year. While predictors have been identified (i.e. lower socioeconomic status, Medicaid/Medicare, younger age, female, leaving against medical advice, etc.), few interventions have been able to concretely show a reduction in the rate of readmission apart from endocrinology consultation. Very few studies have assessed the use of a multi-disciplinary approach in this context. The only study in adults with T1DM which made use of such a team (i.e. ketoacidosis case manager, educators to provide immediate post-discharge contact and follow up along with behavioral health, education and endocrinology follow up) was done in the UK and was able to show significant improvement in readmission and glycemic control over the year-long intervention, but notably had to shut down due to lack of funding. None of these interventions consistently applied technology (i.e. continuous glucose monitoring \[CGM\]) which is known to be able to significantly improve glycemic control within the first month of use in those with poorly controlled T1DM.

Conditions

• Diabetic Ketoacidosis

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring (CGM)	Patients will wear a continuous glucose monitor upon discharge from the hospital for six months
OTHER	Standard of Care	Standard of Care - retrospective review

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-06-24
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study