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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

Be older than 18 years old

Must not have

Significant medical or surgical illness including but not limited to myocardial ischemia, congestive heart failure, chronic peripheral venous insufficiency, chronic renal insufficiency, liver insufficiency (serum transaminases 3 times the upper limit of normal) and acute or chronic infectious processes

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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

Exclusion Criteria

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

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.

Pivotal Trial

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

No Placebo-Only Group

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

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