Ketosis Prone DiabetesPhase 4NCT06699810
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
A Phase 4 study testing Continuous Glucose Monitoring and Insulin in people with Ketosis Prone Diabetes, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ketosis Prone Diabetes
- What is being tested?
- Continuous Glucose Monitoring and Insulin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2025to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
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.
Read the detailed description
Approximately half of newly diagnosed obese African Americans presenting with diabetic ketoacidosis (DKA) have clinical, metabolic and immunologic features of type 2 diabetes (T2D), also known as ketosis-prone diabetes (KPDM). Unlike patients with type 1 diabetes, with intensive insulin treatment, approximately 70% of patients with KPDM exhibit improved pancreatic β-cell function and insulin sensitivity to allow discontinuation of insulin therapy (indicating near-normoglycemia remission based on fasting blood glucose (FBG) < 130 mg/dl and HbA1c < 7% off insulin therapy during follow-up]). The clinical course of KPDM is variable, with the duration of remission ranging from 6 to 120 months. The origins of this variation in the ability to achieve remission and its duration are poorly understood.
It has been observed that a 20-hour infusion of glucose reduces pancreatic beta (β)-cell function in a KPDM patient, and ketotic relapse is often preceded by hyperglycemia. The researchers thus hypothesized that the differences between conventional T2D and KPDM may be explained by the presence of a reversible glucotoxicity process, which operates on the timescale of days. The researchers developed a preliminary mathematical model describing the pathogenesis and remission of KPDM using such a process. The researchers showed that, by changing the rate of this hypothesized glucotoxicity process, this model can produce a variety of clinical courses, describing both conventional T2D and KPDM with varying rates and durations of remission.
This study is a pilot study that will refine and validate this model using prospective clinical data with continuous glucose monitor (CGM) data from patients with KPDM.
Patients will receive standard-of-care treatment for their diabetes as per their treating physician. Insulin therapy is the standard of care after an episode of DKA. Therefore, all participants will be discharged on insulin. A CGM will be placed on these participants at discharge from the hospital until insulin discontinuation. Since many of these patients insulin needs decrease after discharge from the hospital, the study team will utilize CGM glucose readings to adjust insulin doses.
- Conditions
- Ketosis Prone Diabetes
- Being tested
- Continuous Glucose Monitoring, Insulin
- Keywords
- diabetic ketoacidosis, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Ketoacidosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
Also called Freestyle Libre
After insulin discontinuation participants continue wearing their CGMs, for a total of 3 months.
InsulinDrug
Participants will receive standard-of-care insulin treatment. Insulin dosing will be adjusted based on CGM glucose readings.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Glucose Monitoring; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify Changes in Blood Glucose
The day-to-day changes in blood glucose in KPDM will be quantified using CGMs.
Measured: 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.
Measured: Up to 3 months
Secondary outcomes (1)
Correlation of Fit With Model Parameters and Duration of Remission
The study team will validate mathematical models to predict duration of remission.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start23 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketosis Prone DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priyathama Vellanki, Emory University
- Investigators
- Priyathama Vellanki, MD, MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699810
- Sponsor's protocol ID
- STUDY00008366
- Other IDs
- 2024P008641
- Status last verified
- May 2026
- First submitted
- 19 Nov 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
- ClinicalTrials.gov ID
- NCT06699810
- Acronym / sponsor ID
- STUDY00008366
- Conditions
- Ketosis Prone Diabetes
- Keywords
- diabetic ketoacidosis, type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately half of newly diagnosed obese African Americans presenting with diabetic ketoacidosis (DKA) have clinical, metabolic and immunologic features of type 2 diabetes (T2D), also known as ketosis-prone diabetes (KPDM). Unlike patients with type 1 diabetes, with intensive insulin treatment, approximately 70% of patients with KPDM exhibit improved pancreatic β-cell function and insulin sensitivity to allow discontinuation of insulin therapy (indicating near-normoglycemia remission based on fasting blood glucose (FBG) < 130 mg/dl and HbA1c < 7% off insulin therapy during follow-up]). The clinical course of KPDM is variable, with the duration of remission ranging from 6 to 120 months. The origins of this variation in the ability to achieve remission and its duration are poorly understood.
It has been observed that a 20-hour infusion of glucose reduces pancreatic beta (β)-cell function in a KPDM patient, and ketotic relapse is often preceded by hyperglycemia. The researchers thus hypothesized that the differences between conventional T2D and KPDM may be explained by the presence of a reversible glucotoxicity process, which operates on the timescale of days. The researchers developed a preliminary mathematical model describing the pathogenesis and remission of KPDM using such a process. The researchers showed that, by changing the rate of this hypothesized glucotoxicity process, this model can produce a variety of clinical courses, describing both conventional T2D and KPDM with varying rates and durations of remission.
This study is a pilot study that will refine and validate this model using prospective clinical data with continuous glucose monitor (CGM) data from patients with KPDM.
Patients will receive standard-of-care treatment for their diabetes as per their treating physician. Insulin therapy is the standard of care after an episode of DKA. Therefore, all participants will be discharged on insulin. A CGM will be placed on these participants at discharge from the hospital until insulin discontinuation. Since many of these patients insulin needs decrease after discharge from the hospital, the study team will utilize CGM glucose readings to adjust insulin doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring with Adjusted Insulin Doses | Experimental | Device: Continuous Glucose Monitoring, Drug: InsulinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitoringAlso: Freestyle LibreAfter insulin discontinuation participants continue wearing their CGMs, for a total of 3 months. | Device | Continuous Glucose Monitoring with Adjusted Insulin Doses |
| InsulinParticipants will receive standard-of-care insulin treatment. Insulin dosing will be adjusted based on CGM glucose readings. | Drug | Continuous Glucose Monitoring with Adjusted Insulin Doses |
Primary outcome
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.
1 secondary outcome
Correlation of Fit With Model Parameters and Duration of Remission
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Ketosis Prone Diabetes
RecruitingPhase 1/2
Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes
Diabetes (DM), Diabetic Ketoacidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priyathama Vellanki, MD, MS principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Glucose Monitoring and Insulin in people with Ketosis Prone Diabetes, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priyathama Vellanki, MD, MS ((404) 778-1687, priyathama.vellanki@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify Changes in Blood Glucose (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.