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Behavioural Intervention

Technology-Based Care for Diabetic Ketoacidosis (DKA Trial)

N/A
Recruiting
Led By Zhou Keren, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to the hospital with confirmed diabetic ketoacidosis treated with intravenous insulin infusion
Age 18 years old or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to use new technology to help people with type 1 diabetes who are hospitalized for diabetic ketoacidosis. The goal is to improve blood sugar control, decrease hospital readmissions, and provide

Who is the study for?
This trial is for individuals with Type 1 Diabetes who have been admitted for Diabetic Ketoacidosis (DKA). It's designed to test if a new care approach using technology can improve blood sugar control and reduce hospital readmissions.
What is being tested?
The study compares the effectiveness of continuous glucose monitoring (CGM) alongside standard diabetes care versus standard care alone in managing DKA in Type 1 Diabetes patients.
What are the potential side effects?
Continuous Glucose Monitoring is generally safe but may cause skin irritation or discomfort at the sensor site. Standard diabetes care side effects depend on specific treatments used, which can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was hospitalized and treated with IV insulin for diabetic ketoacidosis.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with Type 1 Diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure improvement in glycemic control
Secondary study objectives
Assess change in number of readmissions

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Control Arm - Standard of Care, retrospectiveExperimental Treatment1 Intervention
Retrospective data looking at 12 patients undergoing standard of care for diabetic ketoacidosis
Group II: Intervention Arm - Continuous Glucose Monitoring (CGM)Active Control1 Intervention
12 patients with confirmed diabetic ketoacidosis upon hospital admission will receive continuous glucose monitor (CGM)

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,460 Total Patients Enrolled
1 Trials studying Diabetic Ketoacidosis
39 Patients Enrolled for Diabetic Ketoacidosis
Zhou Keren, MDPrincipal InvestigatorThe Cleveland Clinic
~8 spots leftby Oct 2025
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