Type 1 DiabetesPhase 2KARMANCT07421518
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
A Phase 2 study testing SGLT-2 inhibitor (Sotagliflozin) and Insulin withdrawal test (IWT) in people with Type 1 Diabetes and Type 2 Diabetes, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- SGLT-2 inhibitor (Sotagliflozin) and Insulin withdrawal test (IWT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Apr 2030
- Phase
- Phase 2
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and nonpregnant women ≥18 years and older
- Diagnosis of T1D according to American Diabetes Association (ADA) criteria
- HbA1c < 9 %
- Participants treated with multiple daily injections of insulin, insulin pump, or advanced insulin delivery systems
- Has provided written informed consent to participate in the study.
- Must be willing to wear the investigational device
- Use of adequate contraception for the duration of the study by women of childbearing potential
Who cannot join
- Pregnancy, lactation or planning to become pregnant
- Any form of diabetes other than T1D
- People with T1D using weekly insulin (when approved)
- Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening
- Chronic systematic corticosteroids (>4 consecutive weeks) within 6 months before screening
- History of diabetic ketoacidosis within 6 months of screening
Show all 21Show fewer
- History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening
- Hypotension at screening is defined as systolic blood pressure < 90 and diastolic blood pressure < 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations)
- History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening
- Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening
- New York Heart Association Class IV heart failure
- CKD-EPI estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²
- Impairment of systems and organs that may increase their risk of participating in the intervention study or compromise the results (for example: end stage kidney disease, active liver dysfunction, gastroparesis, anemia, ), organ transplant.
- Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening
- Active Hepatitis B or C, acquired immunodeficiency syndrome (HIV infection controlled with suppressive medications is allowed) or tuberculosis
- Abnormal liver function at screening defined as any of the following: aspartate aminotransferase (AST) >2X upper limit of the normal reference range (ULN), ALT >2X ULN, serum total bilirubin (TB) >1.5X ULN
- Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites, or hepatic encephalopathy), and/or known diagnosis of cirrhosis
- Heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week) at screening, history of alcohol use disorder or binge drinking
- Any condition or factor that would compromise the participant's safety or the scientific integrity of the study (cognitive impairment, bipolar disorder, or history of eating disorder)
- Inability to perform the study follow up/ unwilling to wear the investigational device
- People who are unwilling to consume at least 20% of calories from carbohydrates
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
Official title: Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors
The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- SGLT-2 inhibitor (Sotagliflozin), Insulin withdrawal test (IWT)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitor (Sotagliflozin)Drug
Also called Inpefa
Participants will be asked to take the SGLT-2 inhibitor.
Insulin withdrawal test (IWT)Other
An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| People with Type 1 Diabetes | Other | Not described Receives: Drug: SGLT-2 inhibitor (Sotagliflozin); Other: Insulin withdrawal test (IWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
Number of ketone events with BOHB > 1.5 mmol/L for 15 consecutive minutes, as measured by the DGK. The event will end when BOHB is < 1.5 for 15 consecutive minutes. These events will be measured during the risk mitigation phase (Period 3 and Period 4) of the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study startJun 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Pratley, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421518
- Sponsor's protocol ID
- 2289759
- Acronym
- KARMA
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors
- ClinicalTrials.gov ID
- NCT07421518
- Acronym / sponsor ID
- KARMA / 2289759
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 19 Feb 2026 (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 purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Type 1 Diabetes | Other | Drug: SGLT-2 inhibitor (Sotagliflozin), Other: Insulin withdrawal test (IWT) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and nonpregnant women ≥18 years and older
- Diagnosis of T1D according to American Diabetes Association (ADA) criteria
- HbA1c < 9 %
- Participants treated with multiple daily injections of insulin, insulin pump, or advanced insulin delivery systems
- Has provided written informed consent to participate in the study.
Key exclusion criteria (21 listed)
- Pregnancy, lactation or planning to become pregnant
- Any form of diabetes other than T1D
- People with T1D using weekly insulin (when approved)
- Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening
- Chronic systematic corticosteroids (>4 consecutive weeks) within 6 months before screening
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 |
|---|---|---|
| SGLT-2 inhibitor (Sotagliflozin)Also: InpefaParticipants will be asked to take the SGLT-2 inhibitor. | Drug | People with Type 1 Diabetes |
| Insulin withdrawal test (IWT)An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored. | Other | People with Type 1 Diabetes |
Primary outcome
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
Time frame: 6 months
Number of ketone events with BOHB > 1.5 mmol/L for 15 consecutive minutes, as measured by the DGK. The event will end when BOHB is < 1.5 for 15 consecutive minutes. These events will be measured during the risk mitigation phase (Period 3 and Period 4) of the study.
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 19 Feb 2026.
- AdventHealth Translational Research InstituteLink provided by the sponsor.
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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.
Richard Pratley, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGLT-2 inhibitor (Sotagliflozin) and Insulin withdrawal test (IWT) in people with Type 1 Diabetes and Type 2 Diabetes, run by AdventHealth Translational Research Institute at 1 site 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 7 inclusion and 21 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: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 JaWanda Thacker (407-303-7100, CFD.TRI.Recruitment@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L (time frame: 6 months). 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 19 Feb 2026.