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Clinical Trials/NCT06471322
NCT06471322TerminatedNot Applicable

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

The Cleveland Clinic1 site in 1 country2 target enrollmentStarted: November 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2
Locations
1
Primary Endpoint
Measure improvement in glycemic control

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control Arm - Standard of Care, retrospective

Other

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

Intervention: Standard of Care (Other)

Intervention Arm - Continuous Glucose Monitoring (CGM)

Active Comparator

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

Intervention: Continuous Glucose Monitoring (CGM) (Device)

Outcomes

Primary Outcomes

Measure improvement in glycemic control

Time Frame: 6 months

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.

Secondary Outcomes

  • Assess change in number of readmissions(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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