NCT06699810 · Emory University
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Continuous Glucose Monitoring
After insulin discontinuation participants continue wearing their CGMs, for a total of 3 months.
DRUG
Insulin
Participants will receive standard-of-care insulin treatment. Insulin dosing will be adjusted based on CGM glucose readings.
Primary outcome measures
Quantify Changes in Blood Glucose
Time frame: Up to 3 months
The day-to-day changes in blood glucose in KPDM will be quantified using CGMs.
Development of Mathematical Models
Time frame: Up to 3 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Diagnosis of diabetes \> 90 days before the presentation of DKA
- Unable to give consent
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations