Insulin Glargine for Diabetic Ketoacidosis

Saint Paul, MN

Phase 2

Waitlist Available

Led By Adis Keric, PharmD

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed from time of hospitalization until 48 hour mark after iv insulin discontinuation

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if giving insulin during a medical emergency (DKA) impacts the care of diabetes patients.

See full description

Who is the study for?

This trial is for adults with diabetic ketoacidosis (DKA) who arrive at Regions Hospital ED. They must meet specific criteria like a pH of 7.3 or lower, serum bicarbonate of 18 mEq/L or less, and blood sugar over 250 mg/dL among others. It's not for those under 18, pregnant women, patients with end-stage renal or hepatic disease, on certain insulin therapies before admission, needing emergency surgery, or in critical condition requiring IV vasopressors.

What is being tested?

The study tests the effect of early administration of Insulin Glargine within two hours after starting intravenous insulin infusion in DKA treatment. The goal is to see if this approach improves patient outcomes compared to the usual care where long-acting subcutaneous insulin is given later.See study design

What are the potential side effects?

While not explicitly listed here, common side effects associated with Insulin Glargine may include low blood sugar levels (hypoglycemia), allergic reactions at the injection site such as redness or swelling, itching and weight gain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from time of hospitalization until 48 hour mark after iv insulin discontinuation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed from time of hospitalization until 48 hour mark after iv insulin discontinuation

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from time of hospitalization until 48 hour mark after iv insulin discontinuation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Does early administration of insulin glargine result in a change in ICU length of stay when compared to usual care for the treatment of diabetic ketoacidosis?

Secondary study objectives

Does early administration of insulin glargine result in a change in duration of time on IV insulin infusion when compared to usual care for the treatment of diabetic ketoacidosis?

Does early administration of insulin glargine result in a change in hospital length of stay (defined as time between start of insulin infusion and discharge from hospital) when compared to usual care for the treatment of diabetic ketoacidosis?

Does early administration of insulin glargine result in a change in prevalence of rebound hyperglycemia when compared to usual care for the treatment of diabetic ketoacidosis?

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard of CareActive Control1 Intervention

Subjects presenting to ED with diagnosis of DKA and receiving intravenous short acting insulin will not have orders for subcutaneous insulin glargine placed for research purposes.

Group II: InterventionActive Control1 Intervention

Subjects presenting to ED with diagnosis of DKA will receive study medication set to begin within 2 hours after initiation of the IV insulin infusion. The dose will come from IV pharmacy and dispensed in a 1 mL insulin syringe. If the patient was not taking basal insulin prior to admission, the patient will receive 0.2 units/kg insulin glargine. If the patient was taking basal insulin prior to admission, the patient will receive their home insulin glargine dose.

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