Clinical trial NCT06471322: A Multi-Disciplinary Technology-Based Care for Diabetic Ketoacidosis in Patients with Type 1 Diabetes
Official title: A Multi-Disciplinary Technology-Based Care After Hospitalization for Diabetic Ketoacidosis in Patients with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Ketoacidosis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure improvement in glycemic control
timeFrame: 6 months
Secondary outcomes:
measure: Assess change in number of readmissions
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Zhou Keren, MD
role: PRINCIPAL_INVESTIGATOR
References: