Recruiting
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
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.
ClinicalTrials.gov IDNCT06699810
PhasePHASE4
Enrollment12
SponsorEmory University
Age18 Years and older
SexALL
Conditions studied
Ketosis Prone Diabetes
About this study
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 outcomes
- Quantify Changes in Blood Glucose (Up to 3 months)
- Development of Mathematical Models (Up to 3 months)
Eligibility information
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 locations
- Grady Health System, Atlanta, Georgia 30303 United States
- Emory University Hospital Midtown, Atlanta, Georgia 30308 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-07.