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

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Ketoacidosis
• Intervention / Treatment: Other: Standard of Care; Device: Continuous Glucose Monitoring (CGM)

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years old or older
• Diagnosis of Type 1 Diabetes
• Admitted to the hospital with confirmed DKA as determined by emergency department or admitting team
• Compatible smart phone with the Libre 3
• Active insurance plan

Exclusion Criteria:

• Allergy to any component of the Libre 3
• Condition which, in investigator judgement would limit their ability to participate safely

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Arm - Standard of Care, retrospective; Retrospective data looking at 12 patients undergoing standard of care for diabetic ketoacidosis	Other: Standard of Care; Standard of Care - retrospective review
Active Comparator: Intervention Arm - Continuous Glucose Monitoring (CGM); 12 patients with confirmed diabetic ketoacidosis upon hospital admission will receive continuous glucose monitor (CGM)	Device: Continuous Glucose Monitoring (CGM); Patients will wear a continuous glucose monitor upon discharge from the hospital for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure improvement in glycemic control	To compare improvement in glycemic control (HBA1c measured in % glycosylated hemoglobin) between baseline at hospitalization for DKA and 6 months later using CGM intervention versus standard of care.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess change in number of readmissions	To assess change in number of readmissions between baseline and 6 months later using CGM intervention versus standard of care.	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Zhou Keren, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Diabetes Mellitus; Diabetes Complications; Acid-Base Imbalance; Acidosis; Nutritional and Metabolic Diseases; Ketosis; Diabetic Ketoacidosis; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Quality of Health Care; Quality Indicators, Health Care; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Standard of Care; Continuous Glucose Monitoring
• Other Study ID Numbers: 23-697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No