A Multi-Disciplinary Technology-Based Care for Diabetic Ketoacidosis in Patients with Type 1 Diabetes
- Conditions
- Diabetic Ketoacidosis
- Interventions
- Other: Standard of CareDevice: Continuous Glucose Monitoring (CGM)
- Registration Number
- NCT06471322
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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
- Condition which, in investigator judgement would limit their ability to participate safely
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Control Arm - Standard of Care, retrospective Standard of Care Retrospective data looking at 12 patients undergoing standard of care for diabetic ketoacidosis Intervention Arm - Continuous Glucose Monitoring (CGM) Continuous Glucose Monitoring (CGM) 12 patients with confirmed diabetic ketoacidosis upon hospital admission will receive continuous glucose monitor (CGM)
- Primary Outcome Measures
Name Time Method Measure improvement in glycemic control 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 Outcome Measures
Name Time Method Assess change in number of readmissions 6 months To assess change in number of readmissions between baseline and 6 months later using CGM intervention versus standard of care.
Trial Locations
- Locations (1)
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States