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Continuous Glucose Monitoring for Diabetic Ketoacidosis

N/A

Waitlist Available

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

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

Must have

Meets criteria for new subQ insulin protocol: Diagnosis of DKA or HHS (hyperosmolar hyperglycemic state) and provider decision to initiate insulin

18 years or older

Must not have

Under 18 years of age

Excluded from new subQ protocol, specifically: Acute CHF exacerbation, Acute MI (ACS/NSTEMI type 1 not demand ischemia), CKD stage 4 or AKI with creatinine > 3, ESLD, Pregnancy, Severe sepsis or septic shock, AMS if patient cannot consent, Euglycemic DKA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of hospital stay from admission to discharge (average of 4 days).

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how effective and acceptable it is to use continuous glucose monitoring (CGM) along with fingerstick blood glucose testing (FSBG) in patients following a new protocol for diabetic keto

Who is the study for?

This trial is for individuals with mild to moderate diabetic ketoacidosis, a serious diabetes complication. Participants should have stable vital signs and be able to give informed consent. Details on who can't join are not provided.

What is being tested?

The study tests the use of Continuous Glucose Monitoring (CGM) systems that alert patients about their blood sugar levels during treatment for diabetic ketoacidosis in a hospital setting.

What are the potential side effects?

Specific side effects are not listed, but CGM devices may cause skin irritation or discomfort at the insertion site. Alerts from the device could also lead to anxiety or sleep disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with DKA or HHS and my doctor has decided to start insulin treatment.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I do not have severe heart, kidney, liver issues, am not pregnant, and can consent for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of hospital stay from admission to discharge (average of 4 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of hospital stay from admission to discharge (average of 4 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of hospital stay from admission to discharge (average of 4 days). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine feasibility of CGM placement by hospital staff for patients experiencing hyperglycemia

Secondary study objectives

Describe accuracy and usefulness of CGM for monitoring resolution from hyperglycemia

Evaluate patient safety and care outcomes related to use of CGM during hospitalization

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: CGM with alertsExperimental Treatment1 Intervention

The experimental group will have a Dexcom 7 CGM placed by a trained and credentialed member of the research team, or by a trained care team member (e.g. nurse, physician, diabetes educator). CGM devices will be set to alert the care team when interstitial glucose levels hit 250 mg/dL and 150 mg/dL. Dexcom 7s automatically alert when glucose levels are 55 mg/dL or lower. Nurses will be instructed to check the glucose trends on the CGM device when alerted. They will be asked to check glucose levels with a FSBG according to the following instructions: 1. CGM alerts to interstitial glucose level of 250 mg/dL AND trend indicates rapidly decreasing glucose levels 2. CGM alerts to interstitial glucose level of 150 mg/dL or less.

Group II: CGM without alertsActive Control1 Intervention

The control group will have a Dexcom 7 CGM placed by a trained and credentialed member of the research team, or by a trained care team member (e.g. nurse, physician, diabetes educator). The control group will have the device placed and glucose levels will be collected, but the device will not be set to alert (though note that the Dexcom 7 CGM will always alert when glucose drops below 55 mg/dl, so this alert will exist for both groups).

0 / 4Eligibility criteria met