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Type 1 Diabetes MellitusPhase 2SCOUT-CKDNCT07325201

Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.

A Phase 2 study testing Sotagliflozin initiation in people with Type 1 Diabetes Mellitus and Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), run by HealthPartners Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sotagliflozin initiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Jan 2027to Feb 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 ≥25 (and within prior 12 months).
Show all 12Show fewer
  • HbA1c 7-<-9%.
  • Have never used SGLT2i medications.
  • Must be willing and able to wear a DGK 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).

Who cannot join

  • Pregnant, lactating, or 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 or bacterial infections within 6 months of screening or any history of necrotizing fasciitis.
Show all 29Show fewer
  • 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) <25 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.
  • History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status, in the opinion of the investigator, including, but not limited to patients who have undergone organ or bone marrow transplantation. HIV positive patients who are on stable immunosuppressive therapy and have undetectable viral load may be eligible for inclusion in the study, subject to the investigator's discretion.
  • Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis.
  • 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.
  • History of kidney transplant.
  • Chronic kidney disease (CKD) from a known cause other than T1D.
  • Current or clinically significant history of an eating disorder.
  • BMI <22 at time of screening.
  • Adherence to a very low carbohydrate or ketogenic diet (<100g carbohydrate /day) and unwilling to change during study participation.
  • History of foot amputation.
  • Non-healing wounds of extremities.
  • Documented medical adhesive allergy, as evaluated by investigator.
  • Inability to perform the study follow up or unwilling to wear the DGK device.
  • 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.
  • Participation in another treatment or intervention study within the past six weeks.
  • Any condition or factor that would compromise the participant's safety or conduct of the study (for example: cognitive impairment, bipolar disorder, or eating disorder) or any other reason the PI deems that the patient should not be included.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kelsea Forrester, Dietitian contact

1-952-993-2755

kelsea.r.forrester@healthpartners.com

Rebecca Passi contact

1-952-993-3452

rebecca.a.passi@healthpartners.com

United States1 site

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

    Rebecca Passi, 952-993-3452, passir@healthpartners.com

Other trials in United States

About this study

Official title: Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report

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:

  1. Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods.
  2. Identify potentially modifiable ketosis risk factors.
  3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable.
  4. Gather information on how participants and clinicians like and use the DGK reports.
Read more

Participants will be asked 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 their experience, usefulness of CGM/CKM reports, and the most valuable factors of the Ketone Action Plan (KAP).
Read the detailed description

Sodium-glucose cotransporter 2 (SGLT2) inhibitors and similar medications can prevent progression of heart and kidney disease but strategies to safely use these medications in people with type 1 diabetes (T1D) have not yet been developed. We will conduct an open-label trial of sotagliflozin (an SGLT 1/2 inhibitor) in 80 people with T1D with no chronic kidney disease (CKD), moderate risk CKD and high or very high risk CKD. Through the use of continuous ketone monitoring, we will characterize ketone levels in both individuals with chronic kidney disease (CKD) and T1D, compared to those with T1D without CKD, before and after starting sotagliflozin. We will improve our understanding of the risk factors for developing elevated ketone levels and optimize prevention of diabetes ketoacidosis through the development and refinement of an enhanced combined continuous glucose and ketone monitoring data visualization report.

Being tested
Sotagliflozin initiation
Keywords
Type 1 Diabetes, Chronic Kidney Disease, Continuous Glucose Monitoring, Diabetic Ketoacidosis, Continuous Ketone Monitoring
Medical subject headings
Diabetes Mellitus, Type 1, Renal Insufficiency, Chronic, Diabetic Ketoacidosis, Ketosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sotagliflozin initiationDrug

    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).

Study groups in NCT07325201
Study groupRoleWhat they receive
SotagliflozinExperimentalIn 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.
Receives: Drug: Sotagliflozin initiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in time in ketone range >1.5/mmol/L

    Measured: 3 months, 6 months, 9 months

  2. Number of episodes of diabetic ketoacidosis (DKA)

    Measured: 6 months, 9 months

Secondary outcomes (20)

  1. Change in mean ketone level

    Measured: 3 months, 6 months, 9 months

  2. Highest ketone level in time period

    Measured: 6 months, 9 months

  3. Number of severe hypoglycemia episodes

    Measured: 3 months, 6 months

  4. Number of episodes (>=15 minutes) at >1.5 mmol/L

    Measured: 6 months, 9 months

  5. Number of prolonged episodes (>=2 hours) at >1.5 mmol/L

    Measured: 6 months, 9 months

  6. Change in time in ketone level >3.0/mmol/L

    Measured: 3 months, 6 months, 9 months

  7. Number of episodes (>=15 minutes) at >3.0 mmol/L

    Measured: 6 months, 9 months

  8. Number of prolonged episodes (>=2 hours) at >3.0 mmol/L

    Measured: 6 months, 9 months

  9. Change in time in ketone level >2.5/mmol/L

    Measured: 3 months, 6 months, 9 months

  10. Number of episodes (>=15 minutes) at >2.5 mmol/L

    Measured: 6 months, 9 months

  11. Number of prolonged episodes (>=2 hours) at >2.5 mmol/L

    Measured: 6 months, 9 months

  12. Change in time in ketone level >2.0/mmol/L

    Measured: 3 months, 6 months, 9 months

  13. Number of episodes (>=15 minutes) at >2.0 mmol/L

    Measured: 6 months, 9 months

  14. Number of prolonged episodes (>=2 hours) at >2.0 mmol/L

    Measured: 6 months, 9 months

  15. Change in time in ketone level >1.0/mmol/L

    Measured: 3 months, 6 months, 9 months

  16. Number of episodes (>=15 minutes) at >1.0 mmol/L

    Measured: 6 months, 9 months

  17. Number of prolonged episodes (>=2 hours) at >1.0 mmol/L

    Measured: 6 months, 9 months

  18. Change in time in ketone level >0.6/mmol/L

    Measured: 3 months, 6 months, 9 months

  19. Number of episodes (>=15 minutes) at >0.6 mmol/L

    Measured: 6 months, 9 months

  20. Number of prolonged episodes (>=2 hours) at >0.6 mmol/L

    Measured: 6 months, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2030 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study intervention is an open label trial of 80 individuals with type 1 diabetes all wearing a continuous DGK sensor, divided into 3 cohorts based on renal function (no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD). All 80 participants will be evaluated for glucose control (CGM metrics and HbA1c) and ketone levels (continuous ketone sensor) over 3 study periods, each 3 months long. Period one - no study drug, blinded DGK sensor, period 2 on low starting dose of study drug, 200 mg sotagliflozin, and period 3 on either high dose of study drug, 400 mg sotagliflozin, or continuing low dose study drug). Study drug is oral sotagliflozin, 200 mg or 400 mg once daily. Study visits will be conducted in person at a dedicated study clinical research unit.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07325201
Sponsor's protocol ID
24-153
Other IDs
1U01DK143379
Acronym
SCOUT-CKD
Status last verified
Oct 2026
First submitted
6 Jan 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Steering committee will agree upon a publication and NIH Public Access Policy

Publications

  • Bergenstal RM. Continuous glucose monitoring: transforming diabetes management step by step. Lancet. 2018 Apr 7;391(10128):1334-1336. doi: 10.1016/S0140-6736(18)30290-3. Epub 2018 Feb 16. No abstract available.

    PubMed 29459022

  • Maines E, Pertile R, Cauvin V, Soffiati M, Franceschi R. Glucose metrics improvement in youths with type 1 diabetes using the Ambulatory Glucose Profile report: A real-world study. Diabetes Res Clin Pract. 2024 Jun;212:111720. doi: 10.1016/j.diabres.2024.111720. Epub 2024 May 24.

    PubMed 38797262

  • Huang J, Yeung AM, Bergenstal RM, Castorino K, Cengiz E, Dhatariya K, Niu I, Sherr JL, Umpierrez GE, Klonoff DC. Update on Measuring Ketones. J Diabetes Sci Technol. 2024 May;18(3):714-726. doi: 10.1177/19322968231152236. Epub 2023 Feb 16.

    PubMed 36794812

  • Goldenberg RM, Gilbert JD, Hramiak IM, Woo VC, Zinman B. Sodium-glucose co-transporter inhibitors, their role in type 1 diabetes treatment and a risk mitigation strategy for preventing diabetic ketoacidosis: The STOP DKA Protocol. Diabetes Obes Metab. 2019 Oct;21(10):2192-2202. doi: 10.1111/dom.13811. Epub 2019 Jun 30.

    PubMed 31183975

  • Garg SK, Peters AL, Buse JB, Danne T. Strategy for Mitigating DKA Risk in Patients with Type 1 Diabetes on Adjunctive Treatment with SGLT Inhibitors: A STICH Protocol. Diabetes Technol Ther. 2018 Sep;20(9):571-575. doi: 10.1089/dia.2018.0246. Epub 2018 Aug 21. No abstract available.

    PubMed 30129772

  • Chow E, Clement S, Garg R. Euglycemic diabetic ketoacidosis in the era of SGLT-2 inhibitors. BMJ Open Diabetes Res Care. 2023 Oct;11(5):e003666. doi: 10.1136/bmjdrc-2023-003666.

    PubMed 37797963

  • Wolfsdorf JI, Ratner RE. SGLT Inhibitors for Type 1 Diabetes: Proceed With Extreme Caution. Diabetes Care. 2019 Jun;42(6):991-993. doi: 10.2337/dci19-0008. No abstract available.

    PubMed 31110116

  • Ramphul K, Joynauth J. An Update on the Incidence and Burden of Diabetic Ketoacidosis in the U.S. Diabetes Care. 2020 Dec;43(12):e196-e197. doi: 10.2337/dc20-1258. Epub 2020 Oct 13. No abstract available.

    PubMed 33051332

  • Charleer S, Mathieu C, Nobels F, De Block C, Radermecker RP, Hermans MP, Taes Y, Vercammen C, T'Sjoen G, Crenier L, Fieuws S, Keymeulen B, Gillard P; RESCUE Trial Investigators. Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1224-1232. doi: 10.1210/jc.2017-02498.

    PubMed 29342264

  • Yau K, Dharia A, Alrowiyti I, Cherney DZI. Prescribing SGLT2 Inhibitors in Patients With CKD: Expanding Indications and Practical Considerations. Kidney Int Rep. 2022 May 5;7(7):1463-1476. doi: 10.1016/j.ekir.2022.04.094. eCollection 2022 Jul.

    PubMed 35812300

  • Simonson GD, Criego AB, Battelino T, Carlson AL, Choudhary P, Franc S, Gershenoff D, Grunberger G, Hirsch IB, Isaacs D, Johnson ML, Kerr D, Kruger DF, Mathieu C, Martens TW, Nimri R, Oser SM, Peters AL, Weinstock RS, Wright EE, Wysham CH, Bergenstal RM. Expert Panel Recommendations for a Standardized Ambulatory Glucose Profile Report for Connected Insulin Pens. Diabetes Technol Ther. 2024 Nov;26(11):814-822. doi: 10.1089/dia.2024.0107. Epub 2024 Jun 10.

    PubMed 38758213

  • Mullen DM, Bergenstal R, Criego A, Arnold KC, Goland R, Richter S. Time Savings Using a Standardized Glucose Reporting System and Ambulatory Glucose Profile. J Diabetes Sci Technol. 2018 May;12(3):614-621. doi: 10.1177/1932296817740592. Epub 2017 Nov 24.

    PubMed 29169243

  • Bergenstal RM, Ahmann AJ, Bailey T, Beck RW, Bissen J, Buckingham B, Deeb L, Dolin RH, Garg SK, Goland R, Hirsch IB, Klonoff DC, Kruger DF, Matfin G, Mazze RS, Olson BA, Parkin C, Peters A, Powers MA, Rodriguez H, Southerland P, Strock ES, Tamborlane W, Wesley DM. Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the ambulatory glucose profile. J Diabetes Sci Technol. 2013 Mar 1;7(2):562-78. doi: 10.1177/193229681300700234.

    PubMed 23567014

  • Bergenstal RM. Roadmap to the Effective Use of Continuous Glucose Monitoring: Innovation, Investigation, and Implementation. Diabetes Spectr. 2023 Fall;36(4):327-336. doi: 10.2337/dsi23-0005. Epub 2023 Nov 15.

    PubMed 37982061

  • Beck RW, Bergenstal RM, Cheng P, Kollman C, Carlson AL, Johnson ML, Rodbard D. The Relationships Between Time in Range, Hyperglycemia Metrics, and HbA1c. J Diabetes Sci Technol. 2019 Jul;13(4):614-626. doi: 10.1177/1932296818822496. Epub 2019 Jan 13.

    PubMed 30636519

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotagliflozin initiation in people with Type 1 Diabetes Mellitus and Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), run by HealthPartners 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 12 inclusion and 29 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 23 Oct 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 Kelsea Forrester, Dietitian (1-952-993-2755, kelsea.r.forrester@healthpartners.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in time in ketone range >1.5/mmol/L (time frame: 3 months, 6 months, 9 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?

On the ClinicalTrials.gov record for NCT07325201, which also lists 30 linked publications.

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 23 Oct 2026.

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