Type 1 Diabetes (T1D)Phase 3NCT07211802
CKM For Safe Use of SGLT2i in Type 1 Diabetes
A Phase 3 study testing Sotagliflozin Low Dose, Sotagliflozin High Dose and Dual Continuous Glucose and Ketone Monitor in people with Type 1 Diabetes (T1D), run by University of California, San Diego at 1 site in United States.
Trial summary
This research study is being conducted to learn if wearing a combination continuous glucose monitor/continuous ketone monitor (CGM/CKM) can reduce the side effects of taking sotagliflozin (study drug) in people with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Sotagliflozin Low Dose, Sotagliflozin High Dose and Dual Continuous Glucose and Ketone Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 31 Dec 2031
- Phase
- Phase 3
- 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
- All individuals between the ages of >18 years old, inclusive, at the time of screening;
- Individuals able to become pregnant must:
- be ≥1 year post-menopausal or documented as being surgically sterile, or
- agree to use two methods of contraception during the entire study and for an additional 2 weeks after the end of dosing with the investigational product;
- Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study and for an additional 2 weeks after the end of the treatment period;
- Diagnosed with Type 1 diabetes ≥ 1 year prior to screening, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
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- Treatment with a stable insulin regimen for at least 8 weeks before screening with:
- a continuous subcutaneous insulin infusion (CSII) via a hybrid closed loop system, or
- multiple daily insulin injections;
- Currently using a Continuous Glucose Monitoring (CGM) system;
- Hemoglobin A1c ≤10% at the time of screening;
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2;
- Agrees and is able to wear the investigational device;
- Able to provide written informed consent approved by an Institutional Review Board (IRB).
Who cannot join
- Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening;
- Any concurrent diagnosis of diabetes other than type 1 diabetes;
- History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
- Hypotension at screening as defined as, systolic blood pressure < 90 and diastolic blood pressure < 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations);
- Current or recent (within 1 month prior to screening) use of diabetes medications other than insulin; (examples include, Sodium-Glucose Cotransporter 2 (SGLT-2i), Pramlintide, Metformin);
- Use of glucagon-like-peptide 1 (GLP-1) analogues if not on a stable dose for > 2 months at screening (participants can be rescreened after being on stable dose for > 2 months). Participants on a stable dose of GLP-1 receptor antagonist (RA) and not experiencing frequent vomiting may be included.
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- Chronic systemic corticosteroids use ( > 4 consecutive weeks) within 6 months prior to screening;
- History of diabetic ketoacidosis within 3 months prior screening;
- History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.
- ADA Level 3 Definition - A severe hypoglycemic event characterized by altered mental or physical status requiring the assistance for treatment of hypoglycemia, irrespective of glucose level;
- History of multiple (≥3 infections) genital mycotic infections within 6 months of screening;
- Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
- Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.
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
UCSD - Altman Clinical & Translational Research Institute
La Jolla, California, 92037
Recruiter, 858-246-2146, t1dresearch@health.ucsd.edu
Jeremy Pettus, MD
About this study
Official title: Utilizing Continuous Ketone Monitors to Enable Safe Use of SGLT Inhibitors in Patients With Type 1 Diabetes
This research study is being conducted to learn if wearing a combination continuous glucose monitor/continuous ketone monitor (CGM/CKM) can reduce the side effects of taking sotagliflozin (study drug) in people with type 1 diabetes.
Read the detailed description
The study is a phase 3, single-site, double-blind, random-order, cross-over study to evaluate the use of continuous ketone monitoring (CKM) in participants with type 1 diabetes taking sotagliflozin.
There will be 2 main groups in the study, participants on Hybrid Closed Loop insulin pumps (HCL), n=26, and participants on Multiple Daily Injections (MDI), n=26. There will also be 2 doses of sotagliflozin examined in the study, 200 milligram (mg) once daily and 400mg once daily. Therefore, there will be 4 treatment groups in the study:
- MDI participants who receive 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks;
- MDI participants who receive 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks;
- HCL participants who receive 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks;
- HCL participants who receive 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks.
In addition, there will be an open-label extension study for the HCL group. In the extension study, the 26 participants in the HCL group will remain on their insulin pump, receive a low-dose, open-label, once daily injection of long-acting insulin and complete an additional 6 weeks of dosing with open-label 400 mg sotagliflozin.
For MDI participants there will be a total of 12 visits over approximately 22 weeks. For HCL participants there will be a total of 16 visits over approximately 28 weeks.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Sotagliflozin Low Dose, Sotagliflozin High Dose, Dual Continuous Glucose and Ketone Monitor
- Keywords
- Sotagliflozin, SGLT2, Continuous Ketone Monitor, DGK, CKM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sotagliflozin Low DoseDrug
200 mg Sotagliflozin, once daily for 6 weeks
Sotagliflozin High DoseDrug
400 mg Sotagliflozin, once daily for 6 weeks
Dual Continuous Glucose and Ketone MonitorDevice
Abbott Libre X dual continuous glucose and ketone monitor (DGK) device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks Receives: Drug: Sotagliflozin Low Dose; Drug: Sotagliflozin High Dose; Device: Dual Continuous Glucose and Ketone Monitor |
| Treatment Group B | Experimental | 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks Receives: Drug: Sotagliflozin Low Dose; Drug: Sotagliflozin High Dose; Device: Dual Continuous Glucose and Ketone Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
BHB Time Above 0.6mmol/L - 200mg
Beta hydroxybutyrate (BHB) time > 0.6 millimole per liter (mmol/L) as measured by the DGK during the 200mg dosing period in the MDI vs. HCL groups.
Measured: 6 weeks
BHB Time Above 0.6mmol/L - 400mg
Beta hydroxybutyrate (BHB) time > 0.6 mmol/L as measured by the DGK during the 400mg dosing period in the MDI vs. HCL groups.
Measured: 6 weeks
Secondary outcomes (1)
BHB Time Above 0.6mmol/L - 200mg vs. 400mg
Beta hydroxybutyrate (BHB) time > 0.6 mmol/L as measured by the DGK comparing the 200mg treatment period to the 400mg treatment period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Apr 2027 (estimated)
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Abbott, Lexicon Pharmaceuticals, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jeremy Pettus, MD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211802
- Sponsor's protocol ID
- 812125
- Other IDs
- 1R01DK143381, 1U01DK143381
- Status last verified
- Nov 2026
- First submitted
- 16 Jun 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Continuous Ketone Monitors to Enable Safe Use of SGLT Inhibitors in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07211802
- Acronym / sponsor ID
- 812125
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Sotagliflozin, SGLT2, Continuous Ketone Monitor, DGK, CKM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Abbott, Lexicon Pharmaceuticals, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Oct 2025 (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.
This research study is being conducted to learn if wearing a combination continuous glucose monitor/continuous ketone monitor (CGM/CKM) can reduce the side effects of taking sotagliflozin (study drug) in people with type 1 diabetes.
Detailed description
The study is a phase 3, single-site, double-blind, random-order, cross-over study to evaluate the use of continuous ketone monitoring (CKM) in participants with type 1 diabetes taking sotagliflozin.
There will be 2 main groups in the study, participants on Hybrid Closed Loop insulin pumps (HCL), n=26, and participants on Multiple Daily Injections (MDI), n=26. There will also be 2 doses of sotagliflozin examined in the study, 200 milligram (mg) once daily and 400mg once daily. Therefore, there will be 4 treatment groups in the study:
- MDI participants who receive 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks;
- MDI participants who receive 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks;
- HCL participants who receive 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks;
- HCL participants who receive 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks.
In addition, there will be an open-label extension study for the HCL group. In the extension study, the 26 participants in the HCL group will remain on their insulin pump, receive a low-dose, open-label, once daily injection of long-acting insulin and complete an additional 6 weeks of dosing with open-label 400 mg sotagliflozin.
For MDI participants there will be a total of 12 visits over approximately 22 weeks. For HCL participants there will be a total of 16 visits over approximately 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: Sotagliflozin Low Dose, Drug: Sotagliflozin High Dose, Device: Dual Continuous Glucose and Ketone Monitor200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks |
| Treatment Group B | Experimental | Drug: Sotagliflozin Low Dose, Drug: Sotagliflozin High Dose, Device: Dual Continuous Glucose and Ketone Monitor400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All individuals between the ages of >18 years old, inclusive, at the time of screening;
- Individuals able to become pregnant must:
- Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study and for an additional 2 weeks after the end of the treatment period;
- Diagnosed with Type 1 diabetes ≥ 1 year prior to screening, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
- Treatment with a stable insulin regimen for at least 8 weeks before screening with:
Key exclusion criteria (13 listed)
- Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening;
- Any concurrent diagnosis of diabetes other than type 1 diabetes;
- History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
- Hypotension at screening as defined as, systolic blood pressure < 90 and diastolic blood pressure < 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations);
- Current or recent (within 1 month prior to screening) use of diabetes medications other than insulin; (examples include, Sodium-Glucose Cotransporter 2 (SGLT-2i), Pramlintide, Metformin);
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 |
|---|---|---|
| Sotagliflozin Low Dose200 mg Sotagliflozin, once daily for 6 weeks | Drug | Treatment Group A, Treatment Group B |
| Sotagliflozin High Dose400 mg Sotagliflozin, once daily for 6 weeks | Drug | Treatment Group A, Treatment Group B |
| Dual Continuous Glucose and Ketone MonitorAbbott Libre X dual continuous glucose and ketone monitor (DGK) device. | Device | Treatment Group A, Treatment Group B |
Primary outcome
BHB Time Above 0.6mmol/L - 200mg
Time frame: 6 weeks
Beta hydroxybutyrate (BHB) time > 0.6 millimole per liter (mmol/L) as measured by the DGK during the 200mg dosing period in the MDI vs. HCL groups.
BHB Time Above 0.6mmol/L - 400mg
Time frame: 6 weeks
Beta hydroxybutyrate (BHB) time > 0.6 mmol/L as measured by the DGK during the 400mg dosing period in the MDI vs. HCL groups.
1 secondary outcome
BHB Time Above 0.6mmol/L - 200mg vs. 400mg
Time frame: 6 weeks
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sotagliflozin Low Dose, Sotagliflozin High Dose and Dual Continuous Glucose and Ketone Monitor in people with Type 1 Diabetes (T1D), run by University of California, San Diego 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 14 inclusion and 13 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 4 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Program Manager, MS (858-246-2169, t1dresearch@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BHB Time Above 0.6mmol/L - 200mg (time frame: 6 weeks). 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 4 Nov 2026.