Recruiting

Ketosis-Prone Diabetes

Sponsor:

Emory University

Code:

NCT06699810

Conditions

Ketosis Prone Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitoring

Insulin

Study Details

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

Study ID

NCT06699810

Start date

Jan 23, 2025

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Continuous Glucose Monitoring with Adjusted Insulin Doses

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.

Interventions

Continuous Glucose Monitoring

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

Insulin

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

Primary outcome measure

  • Quantify Changes in Blood Glucose [ Time Frame: Up to 3 months ]
  • Development of Mathematical Models [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Priyathama Vellanki, MD, MS

(404) 778-1687priyathama.vellanki@emory.edu

Locations

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

More Information

Sponsor

Emory University

Last update posted

Jun 15, 2026

Last verified

May, 2026

Keywords

  • diabetic ketoacidosis
  • type 2 diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-15.