Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring

NCT07325201 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 24-1531U01DK143379
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to:

• Meet with study investigators to determine if they are eligible
• Sign written informed consent
• Take a pregnancy test, if applicable
• Have blood taken to assess kidney function and hemoglobin A1c
• Take the study medication, following the study team instructions
• Wear the study provided sensor throughout participation.
• Complete 5 in person visits, and 11 phone check ins over a nine-month period
• Provide feedback on the usefulness of CGM/CKM reports

Conditions

Type 1 Diabetes Mellitus; Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM); Chronic Kidney Disease

Keywords

Type 1 Diabetes; Chronic Kidney Disease; Continuous Glucose Monitoring; Diabetic Ketoacidosis; Continuous Ketone Monitoring

Outcome Measures

Primary Outcomes (2)

• Change in % time in ketone range >1.5/mmol/L

  Baseline 3 months to 3 months following sotagliflozin initiation

• Number of episodes of diabetic ketoacidosis

  ADA/EASD consensus on hyperglycemia definition of DKA will be used for the definition of DKA (must meet all 3 criteria: Glucose ≥200 mg/dL (11.1 mmol/L) OR prior history of diabetes; BHB concentration ≥3.0 mmol/L OR urine ketone strip 2+ or greater; pH \<7.3 and/or bicarbonate concentration \<18 mmol/L)

  3 months following sotagliflozin initiation

Secondary Outcomes (10)

• Change in mean ketone level

  Baseline 3 months to 3 months following sotagliflozin initiation

• Highest ketone level observed

  3 months following sotagliflozin initiation

• Number of episodes of ketosis with >=15 minutes at >1.5 mmol/L

  3 months following sotagliflozin initiation

• Number of prolonged episodes of ketosis with >=120 minutes at >1.5 mmol/L

  3 months following sotagliflozin initiation

• Change in % time in ketone range >=3.0/mmol/L

  Baseline 3 months to 3 months following sotagliflozin initiation

Other Outcomes (3)

• Change in A1c

  3- and 6-months following sotagliflozin initiation and titration

• Change in CGM metrics

  3-and 6-months following sotagliflozin initiation and titration

• Reduction in insulin total daily dose

  3-and 6-months following sotagliflozin initiation and titration

Study Arms (1)

Sotagliflozin

EXPERIMENTAL

In this single arm trial, all patients will be started on sotagliflozin at a dose of 200mg/d. After 3 months of sotagliflozin 200 mg/d, patients who do not achieve good glycemic control (TIR \>60%) and who have moderate or no CKD (eGFR \>60) will be offered the option to increase sotagliflozin to 400mg/d. All other participants will continue taking 200 mg sotagliflozin daily.

Drug: Sotagliflozin initiation

Interventions

Sotagliflozin initiation DRUG

All patients will be started on sotagliflozin at a dose of 200mg/d. After 3 months of sotagliflozin 200 mg/d, patients who do not achieve good glycemic control (TIR \>60%) and who have moderate or no CKD (eGFR \>60) will be offered the option to increase sotagliflozin to 400mg/d. The decision to increase sotagliflozin dose will be a shared decision between the study subject and the study investigators. All other participants will continue taking 200 mg sotagliflozin daily. After completing all study visits, all participants will stop taking sotagliflozin and continue care with their healthcare provider(s).

Sotagliflozin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Males and females; Ages 18-75.
• Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening.
• Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)).
• Most recent eGFR ≥30 (and within prior 12 months).
• HbA1c \<10%. 8) Have had ≥1 primary or specialty ambulatory visit(s) in the past year in the HealthPartners care system.
• Have never been prescribed SGLT2i medications.
• Must be willing and able to wear a CGM/CKM device and willing to follow the study protocol.
• Must be able to read and speak English.
• Use of adequate contraception for the duration of the study be the women of childbearing potential.
• Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).

You may not qualify if:

• Pregnancy, lactation, planning to become pregnant or unwillingness to be on contraception during the trial.
• Any form of diabetes other than T1D.
• Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months.
• Chronic systemic corticosteroids (\>4 consecutive weeks) within 6 months before screening or planned use during the study period.
• History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year.
• History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening.
• 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).
• 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).
• Active Hepatitis B or C, 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Renal Insufficiency, Chronic; Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Study Officials

• Richard Bergenstal, MD

  HealthPartners/Park Nicollet International Diabetes Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsea Forrester, Dietitian

CONTACT

1-952-993-2755; kelsea.forrester@parknicollet.com

Rebecca Passi

CONTACT

1-952-993-3452; rebecca.passi@parknicollet.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will be started on sotagliflozin at a dose of 200 mg/d. After 3 months of sotagliflozin 200 mg/d, patients who do not achieve good glycemic control (Time In Range \>60%) and who have moderate or no chronic kidney disease (estimated Glomerular Filtration Rate \>60) will be offered the option to increase sotagliflozin to 400 mg/d. The decision to increase sotagliflozin dose will be a shared decision between the study subject and the study investigators.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)