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

NeuroTherapia, Inc.

Status: Terminated

Conditions: Diabetic Ketoacidosis

Treatments: Other: Standard of Care; Device: Continuous Glucose Monitoring (CGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06471322

23-697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years old or older
• Diagnosis of Type 1 Diabetes
• Admitted to the hospital with confirmed diabetic ketoacidosis treated with intravenous insulin infusion
• No prior use of continuous glucose monitoring (CGM)
• Compatible smart phone with CGM
• Allergy to any component of the CGM

Exclusion criteria

• Condition which, in investigator judgement would limit their ability to participate safely

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Control Arm - Standard of Care, retrospective

Other group

Description:

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

Treatment:

Other: Standard of Care

Intervention Arm - Continuous Glucose Monitoring (CGM)

Active Comparator group

Description:

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

Treatment:

Device: Continuous Glucose Monitoring (CGM)