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

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.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease; Type 1 Diabetes Mellitus; Diabetic Ketoacidosis; Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM); Ketones
• Intervention / Treatment: Drug: Sotagliflozin initiation

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kelsea Forrester, Dietitian; Phone Number: 1-952-993-2755; Email: kelsea.r.forrester@healthpartners.com
• Study Contact Backup: Name: Rebecca Passi; Phone Number: 1-952-993-3452; Email: rebecca.a.passi@healthpartners.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center
      • Contact: Rebecca Passi; Phone Number: 1-952-993-3452; Email: passir@healthpartners.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Males and females; Ages 18-75.
4. Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening.
5. 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)).
6. Most recent eGFR ≥25 (and within prior 12 months).
7. HbA1c 7-<-9%.
8. Have never used SGLT2i medications.
9. Must be willing and able to wear a DGK device and willing to follow the study protocol.
10. Must be able to read and speak English.
11. Use of adequate contraception for the duration of the study be the women of childbearing potential.
12. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).

Exclusion Criteria:

1. Pregnant, lactating, or planning to become pregnant or unwillingness to be on contraception during the trial.
2. Any form of diabetes other than T1D.
3. Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months.
4. Chronic systemic corticosteroids (>4 consecutive weeks) within 6 months before screening or planned use during the study period.
5. History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year.
6. History of multiple (≥ 3 infections) genital mycotic or bacterial infections within 6 months of screening or any history of necrotizing fasciitis.
7. 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).
8. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.
9. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening.
10. New York Heart Association Class IV heart failure.
11. CKD-EPI estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m2.
12. 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).
13. Active Hepatitis B or C, or tuberculosis.
14. 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.
15. 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.
16. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis.
17. 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.
18. History of kidney transplant.
19. Chronic kidney disease (CKD) from a known cause other than T1D.
20. Current or clinically significant history of an eating disorder.
21. BMI <22 at time of screening.
22. Adherence to a very low carbohydrate or ketogenic diet (<100g carbohydrate /day) and unwilling to change during study participation.
23. History of foot amputation.
24. Non-healing wounds of extremities.
25. Documented medical adhesive allergy, as evaluated by investigator.
26. Inability to perform the study follow up or unwilling to wear the DGK device.
27. 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.
28. Participation in another treatment or intervention study within the past six weeks.
29. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sotagliflozin; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in time in ketone range >1.5/mmol/L	3 months, 6 months, 9 months
Number of episodes of diabetic ketoacidosis (DKA)	6 months, 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in mean ketone level	3 months, 6 months, 9 months
Highest ketone level in time period	6 months, 9 months
Number of severe hypoglycemia episodes	3 months, 6 months
Number of episodes (>=15 minutes) at >1.5 mmol/L	6 months, 9 months
Number of prolonged episodes (>=2 hours) at >1.5 mmol/L	6 months, 9 months
Change in time in ketone level >3.0/mmol/L	3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >3.0 mmol/L	6 months, 9 months
Number of prolonged episodes (>=2 hours) at >3.0 mmol/L	6 months, 9 months
Change in time in ketone level >2.5/mmol/L	3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >2.5 mmol/L	6 months, 9 months
Number of prolonged episodes (>=2 hours) at >2.5 mmol/L	6 months, 9 months
Change in time in ketone level >2.0/mmol/L	3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >2.0 mmol/L	6 months, 9 months
Number of prolonged episodes (>=2 hours) at >2.0 mmol/L	6 months, 9 months
Change in time in ketone level >1.0/mmol/L	3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >1.0 mmol/L	6 months, 9 months
Number of prolonged episodes (>=2 hours) at >1.0 mmol/L	6 months, 9 months
Change in time in ketone level >0.6/mmol/L	3 months, 6 months, 9 months
Number of episodes (>=15 minutes) at >0.6 mmol/L	6 months, 9 months
Number of prolonged episodes (>=2 hours) at >0.6 mmol/L	6 months, 9 months

Other Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c	3 months, 6 months, 9 months
Change in CGM metrics	3 months, 6 months, 9 months
Change in insulin total daily dose (TDD)	3 months, 6 months, 9 months
Change in carbohydrate intake	3 months, 6 months, 9 months
Report of any symptoms related to elevated ketones	6 months, 9 months
Report of any use of Ketone Action Plan	6 months, 9 months
Change in extent of renal disease	3 months, 6 months, 9 months
Change in other renal disease indicators	3 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Richard Bergenstal, MD, HealthPartners/Park Nicollet International Diabetes Center

Publications and helpful links

General Publications

• Neal B, Perkovic V, Matthews DR. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Nov 23;377(21):2099. doi: 10.1056/NEJMc1712572. No abstract available.
• 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.
• Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
• Menne J, Dumann E, Haller H, Schmidt BMW. Acute kidney injury and adverse renal events in patients receiving SGLT2-inhibitors: A systematic review and meta-analysis. PLoS Med. 2019 Dec 9;16(12):e1002983. doi: 10.1371/journal.pmed.1002983. eCollection 2019 Dec.
• Heerspink HJ, Perkins BA, Fitchett DH, Husain M, Cherney DZ. Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Diabetes Mellitus: Cardiovascular and Kidney Effects, Potential Mechanisms, and Clinical Applications. Circulation. 2016 Sep 6;134(10):752-72. doi: 10.1161/CIRCULATIONAHA.116.021887. Epub 2016 Jul 28.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Bergenstal RM, Bode BW, Bhargava A, Wang Q, Knights AW, Chang AM. Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes. Diabetes Ther. 2023 Nov;14(11):1933-1945. doi: 10.1007/s13300-023-01476-4. Epub 2023 Sep 23.
• Bergenstal RM, Mullen DM, Strock E, Johnson ML, Xi MX. Randomized comparison of self-monitored blood glucose (BGM) versus continuous glucose monitoring (CGM) data to optimize glucose control in type 2 diabetes. J Diabetes Complications. 2022 Mar;36(3):108106. doi: 10.1016/j.jdiacomp.2021.108106. Epub 2021 Dec 31.
• Zhang JY, Shang T, Koliwad SK, Klonoff DC. Continuous Ketone Monitoring: A New Paradigm for Physiologic Monitoring. J Diabetes Sci Technol. 2021 Jul;15(4):775-780. doi: 10.1177/19322968211009860. Epub 2021 Apr 9.
• Bergenstal RM, Simonson GD, Heinemann L. More Green, Less Red: How Color Standardization May Facilitate Effective Use of CGM Data. J Diabetes Sci Technol. 2022 Jan;16(1):3-6. doi: 10.1177/19322968211053341. Epub 2021 Oct 28. No abstract available.
• Tecce N, de Alteriis G, de Alteriis G, Verde L, Tecce MF, Colao A, Muscogiuri G. Harnessing the Synergy of SGLT2 Inhibitors and Continuous Ketone Monitoring (CKM) in Managing Heart Failure among Patients with Type 1 Diabetes. Healthcare (Basel). 2024 Mar 29;12(7):753. doi: 10.3390/healthcare12070753.
• Virdi N, Poon Y, Abaniel R, Bergenstal RM. Prevalence, Cost, and Burden of Diabetic Ketoacidosis. Diabetes Technol Ther. 2023 Jun;25(S3):S75-S84. doi: 10.1089/dia.2023.0149.
• Danne T, Garg S, Peters AL, Buse JB, Mathieu C, Pettus JH, Alexander CM, Battelino T, Ampudia-Blasco FJ, Bode BW, Cariou B, Close KL, Dandona P, Dutta S, Ferrannini E, Fourlanos S, Grunberger G, Heller SR, Henry RR, Kurian MJ, Kushner JA, Oron T, Parkin CG, Pieber TR, Rodbard HW, Schatz D, Skyler JS, Tamborlane WV, Yokote K, Phillip M. International Consensus on Risk Management of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Treated With Sodium-Glucose Cotransporter (SGLT) Inhibitors. Diabetes Care. 2019 Jun;42(6):1147-1154. doi: 10.2337/dc18-2316. Epub 2019 Feb 6.
• Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simo R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.
• Buse JB, Garg SK, Rosenstock J, Bailey TS, Banks P, Bode BW, Danne T, Kushner JA, Lane WS, Lapuerta P, McGuire DK, Peters AL, Reed J, Sawhney S, Strumph P. Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study. Diabetes Care. 2018 Sep;41(9):1970-1980. doi: 10.2337/dc18-0343. Epub 2018 Jun 24.
• Bailey CJ, Day C, Bellary S. Renal Protection with SGLT2 Inhibitors: Effects in Acute and Chronic Kidney Disease. Curr Diab Rep. 2022 Jan;22(1):39-52. doi: 10.1007/s11892-021-01442-z. Epub 2022 Feb 3.
• Clegg LE, Heerspink HJL, Penland RC, Tang W, Boulton DW, Bachina S, Fox RD, Fenici P, Thuresson M, Mentz RJ, Hernandez AF, Holman RR. Reduction of Cardiovascular Risk and Improved Estimated Glomerular Filtration Rate by SGLT2 Inhibitors, Including Dapagliflozin, Is Consistent Across the Class: An Analysis of the Placebo Arm of EXSCEL. Diabetes Care. 2019 Feb;42(2):318-326. doi: 10.2337/dc18-1871. Epub 2018 Dec 6.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Chronic Kidney Disease; Type 1 Diabetes; Diabetic Ketoacidosis; Continuous Ketone Monitoring
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Complications; Renal Insufficiency; Acid-Base Imbalance; Acidosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Renal Insufficiency, Chronic; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: 24-153; 1U01DK143379 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Steering committee will agree upon a publication and NIH Public Access Policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No