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.
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
- Conditions the study is for
- Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), Chronic Kidney Disease
- 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
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).
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- 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.
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- 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.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
Rebecca Passi, 952-993-3452, passir@healthpartners.com
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:
- 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.
- Identify potentially modifiable ketosis risk factors.
- 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.
- 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.
- Conditions
- Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), Chronic Kidney Disease, Diabetic Ketoacidosis, Ketones
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sotagliflozin initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time in ketone range >1.5/mmol/L
Measured: 3 months, 6 months, 9 months
Number of episodes of diabetic ketoacidosis (DKA)
Measured: 6 months, 9 months
Secondary outcomes (20)
Change in mean ketone level
Measured: 3 months, 6 months, 9 months
Highest ketone level in time period
Measured: 6 months, 9 months
Number of severe hypoglycemia episodes
Measured: 3 months, 6 months
Number of episodes (>=15 minutes) at >1.5 mmol/L
Measured: 6 months, 9 months
Number of prolonged episodes (>=2 hours) at >1.5 mmol/L
Measured: 6 months, 9 months
Change in time in ketone level >3.0/mmol/L
Measured: 3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >3.0 mmol/L
Measured: 6 months, 9 months
Number of prolonged episodes (>=2 hours) at >3.0 mmol/L
Measured: 6 months, 9 months
Change in time in ketone level >2.5/mmol/L
Measured: 3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >2.5 mmol/L
Measured: 6 months, 9 months
Number of prolonged episodes (>=2 hours) at >2.5 mmol/L
Measured: 6 months, 9 months
Change in time in ketone level >2.0/mmol/L
Measured: 3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >2.0 mmol/L
Measured: 6 months, 9 months
Number of prolonged episodes (>=2 hours) at >2.0 mmol/L
Measured: 6 months, 9 months
Change in time in ketone level >1.0/mmol/L
Measured: 3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >1.0 mmol/L
Measured: 6 months, 9 months
Number of prolonged episodes (>=2 hours) at >1.0 mmol/L
Measured: 6 months, 9 months
Change in time in ketone level >0.6/mmol/L
Measured: 3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >0.6 mmol/L
Measured: 6 months, 9 months
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.
- First posted8 Jan 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Bergenstal, MD, Principal investigator, HealthPartners/Park Nicollet International Diabetes Center
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 29459022Maines 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 38797262Huang 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 36794812Goldenberg 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 31183975Garg 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 30129772Chow 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 37797963Wolfsdorf 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 31110116Ramphul 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 33051332Charleer 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 29342264Yau 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 35812300Simonson 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 38758213Mullen 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 29169243Bergenstal 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 23567014Bergenstal 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 37982061Beck 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