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Insulin

Continuous Glucose Monitoring and Insulin for Ketosis-Prone Diabetes

Phase 4

Recruiting

Led By Priyathama Vellanki, MD, MS

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Have a BMI ≥ 28 kg/m2

Be older than 18 years old

Must not have

Have recognized uncontrolled endocrine disorders such as hypercortisolism, acromegaly, or hyperthyroidism

Unable to give consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to measure how blood sugar levels change daily during treatment for a specific type of diabetes called ketosis-prone diabetes (KPDM). Researchers will use a mathematical model to explain how KPDM

Who is the study for?

This trial is for individuals with ketosis-prone diabetes (KPDM), a condition where the body produces high levels of blood acids called ketones. Participants should be experiencing this for the first time or have a history of similar episodes but not on long-term insulin therapy.

What is being tested?

The study is monitoring day-to-day blood sugar levels using Continuous Glucose Monitoring systems and treating participants with insulin to understand how KPDM goes into remission and to develop a mathematical model describing this process.

What are the potential side effects?

Continuous glucose monitoring is generally safe, involving wearing a device that measures sugar levels. Insulin can cause low blood sugar, allergic reactions at injection sites, weight gain, or swelling in arms and legs.

Eligibility Criteria

Inclusion Criteria

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

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My BMI is 28 or higher.

Exclusion Criteria

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

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I have an untreated hormone disorder like high cortisol, acromegaly, or overactive thyroid.

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I am unable to understand and give consent for treatment.

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I have anemia or a bleeding disorder.

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I do not have major health issues like heart failure, severe kidney or liver problems, or ongoing infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Development of Mathematical Models

Quantify Changes in Blood Glucose

Secondary study objectives

Correlation of Fit With Model Parameters and Duration of Remission

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Continuous Glucose Monitoring with Adjusted Insulin DosesExperimental Treatment2 Interventions

Patients with ketosis-prone diabetes will wear a continuous glucose monitor (CGM) from the time of hospital discharge until insulin discontinuation. Insulin doses will be adjusted based on CGM glucose readings.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitoring

2023

Completed Phase 2

~1000

Insulin

2000

Completed Phase 4

~4280