Diabetic Ketoacidosis
Conditions
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.
Interventions
DEVICEContinuous Glucose Monitoring (CGM)
Patients will wear a continuous glucose monitor upon discharge from the hospital for six months
OTHERStandard of Care
Standard of Care - retrospective review
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZhou Keren, MD
The Cleveland Clinic
Outcome results
None listed