Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

NCT06699810 | Active Not Recruiting Phase 4 FDA Drug FDA Device

• 2 other identifiers: STUDY000083662024P008641
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.

Conditions

Ketosis Prone Diabetes

Keywords

diabetic ketoacidosis; type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Quantify Changes in Blood Glucose

  The day-to-day changes in blood glucose in KPDM will be quantified using CGMs.

  Up to 3 months

• Development of Mathematical Models

  The study team will adapt and develop mathematical models to describe the course of KPDM remission in each individual patient, i.e. the entire range of variation within the group of 12 participants.

  Up to 3 months

Secondary Outcomes (1)

• Correlation of Fit With Model Parameters and Duration of Remission

  Up to 3 months

Study Arms (1)

Continuous Glucose Monitoring with Adjusted Insulin Doses

EXPERIMENTAL

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.

Device: Continuous Glucose Monitoring; Drug: Insulin

Interventions

Continuous Glucose Monitoring DEVICE

After insulin discontinuation participants continue wearing their CGMs, for a total of 3 months.

Also known as: Freestyle Libre

Continuous Glucose Monitoring with Adjusted Insulin Doses

Insulin DRUG

Participants will receive standard-of-care insulin treatment. Insulin dosing will be adjusted based on CGM glucose readings.

Continuous Glucose Monitoring with Adjusted Insulin Doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent
• Have a BMI ≥ 28 kg/m2
• Be of African American ancestry
• Meet diagnostic criteria for DKA. Diagnostic criteria for DKA will include a plasma glucose \> 250 mg/dl, a venous pH \< 7.30, a serum bicarbonate \< 18 mmol/l, and serum ketones (beta-hydroxy butyrate) \> 1.5 mmol/L.

You may not qualify if:

• 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
• Anemia (hemoglobin \< 12.5 g/dL for men, \<11.5 gm/dL for women), bleeding disorders, or abnormalities in coagulation studies
• Pregnant
• Diagnosis of diabetes \> 90 days before the presentation of DKA
• Unable to give consent

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Priyathama Vellanki, MD, MS

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: January 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)