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

NCT06471322 | Terminated FDA Device

• 1 other identifier: 23-697
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess change in number of readmissions

  6 months

Study Arms (2)

Control Arm - Standard of Care, retrospective

OTHER

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

Other: Standard of Care

Intervention Arm - Continuous Glucose Monitoring (CGM)

ACTIVE COMPARATOR

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

Device: Continuous Glucose Monitoring (CGM)

Interventions

Continuous Glucose Monitoring (CGM) DEVICE

Patients will wear a continuous glucose monitor upon discharge from the hospital for six months

Intervention Arm - Continuous Glucose Monitoring (CGM)

Standard of Care OTHER

Standard of Care - retrospective review

Control Arm - Standard of Care, retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis

Interventions

Continuous Glucose Monitoring; Standard of Care

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Zhou Keren, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control Arm: Historical group of patients admitted for DKA In the prior 1 year Intervention: Patients with type 1 diabetes mellitus admitted to the hospital with confirmed diabetic ketoacidosis treated with intra-venous insulin infusion.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: November 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)