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Continuous ketone monitoring with the use of SGLT2 inhibitors in T1D

Award Number: U01DK143386
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2025
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Continuous ketone monitoring with the use of SGLT2 inhibitors in T1D - Applicant: Ahmad Haidar Project Summary: Abstract Diabetic ketoacidosis (DKA) is still a life-threatening risk in type 1 diabetes (T1D) that can occur with acute illness or insulin interruption. Currently, the only means to monitor this risk are capillary or urine testing, which provide few measurements only prompted by symptoms of the patient, or by monitoring for high glucose levels with continuous glucose monitoring, which do not always correlate with ketosis. Sodium-glucose-linked cotransporter 2 (SGLT2) inhibitors are a group of anti-hyperglycemic medications that have been shown to have cardiovascular and renal benefits, and reduce all- cause mortality in those with and without diabetes. These medications, when studied in T1D, increased risk of euglycemic DKA except with empagliflozin 2.5 mg, which had no renal benefit in post-hoc analyses. Despite the risk, their off-label use in T1D remains common worldwide. A continuous ketone monitor (CKM) has the potential to revolutionize the safety around ketosis management. A sensor that alarms at increasing levels of beta-hydroxybutyrate can allow for immediate action to prevent DKA from occurring. It can also provide useful information on normal biochemistry with SGLT2 inhibitor use in T1D. We aim to conduct a 2-part outpatient study, assessing the use of CKM to reduce ketosis and DKA while using SGLT2 inhibitors. In Part 1A, 24 participants with T1D will use a CKM and be given empagliflozin 2.5 mg for four weeks then empagliflozin 10 mg for five weeks. Participants will perform an exercise challenge during the fourth week of empagliflozin 10 mg use and be on a low-carb diet during the last week of empagliflozin 10 mg use. From this study, CKM data and participant characteristics will be collected to better understand how changes in ketone levels are affected by varying doses of empagliflozin, and which metrics help predict ketosis and DKA. Using this data, we will refine our CKM algorithm that aims to (1) prevent DKA in people with T1D on empagliflozin, and (2) identify which individuals can continue safely on higher doses of empagliflozin. Moreover, we aim to develop educational guidelines pertaining to the general use of the CKM system, and its use in managing DKA risk, exercise, and low-carb diets. Part 2 will be a 6-month study where 72 participants with T1D will use a CKM and be given empagliflozin at escalating doses until they reach their maximum tolerated dose, as determined by our refined algorithm. Education will be provided using the educational guidelines developed in Part 1, and the efficacy of our refined algorithm will be assessed. The goal of our work is to provide a safe way for people with T1D to use SGLT2 inhibitors. Page 1 of 1


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $194,654 )
2025	2025	THE ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING	845 ST SHERBROOKE W	MONTREAL	QC			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/5/2025	NEW	$71,319
2025	2025	THE ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING	845 ST SHERBROOKE W	MONTREAL	QC			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	9/8/2025	SUPPLEMENT FOR EXPANSION	$123,335
														Subtotal = $194,654

Grand Total All Awards = $194,654

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Continuous ketone monitoring with the use of SGLT2 inhibitors in T1D

Award Number: U01DK143386

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/10/2025

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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