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The Evaluation of Two Response Thresholds to Continuous Ketone Monitoring Information Minimising Ketosis in People with Type 1 Diabetes Treated with Sotagliflozin.

Award Number: U01DK143330
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: 09/12/2025
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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The Evaluation of Two Response Thresholds to Continuous Ketone Monitoring Information Minimising Ketosis in People with Type 1 Diabetes Treated with Sotagliflozin. - Type 1 diabetes (T1D) is associated with three times the mortality of the general population and on average an 11-year reduction in life expectancy. Cardiovascular disease (CVD) and renal disease are major contributing factors to increased mortality in people with T1D. Sodium Glucose Linked Transporter inhibitors (SGLTi) have revolutionized the management of type 2 diabetes as they can improve glucose levels and significantly reduce the development of CVD and renal complications which include a reduction in mortality, however people with T1D are missing out on this revolutionary treatment as they can cause diabetic ketoacidosis. While SGLTi therapy as an adjunct to insulin may benefit people with T1D, in general their use has been associated with a significantly increased risk of diabetic ketoacidosis (DKA) which may occur in the absence of hyperglycemia. For example, the pooled analysis of DEPICT-1 and DEPICT-2 participants showed that over 52 weeks of treatment, the incidence of adjudicated DKA was numerically higher in people with T1D treated with dapagliflozin 5 mg/day or 10 mg/day than with placebo (4.0% and 3.5% vs. 1.1%). Therefore, regulatory authorities have continued to not approve the use of this class of agent in T1D. The early recognition of ketosis is of critical importance in preempting the development of DKA. A continuous glucose and ketone monitor (CGKM) may increase an individual’s awareness of rising ketone levels allowing them to take remedial action. However, the most appropriate ketone thresholds at which responses should be initiated remain unknown. We propose a randomized-controlled study where 115 participants are provided with dapagliflozin 10 mg/day and a CGKM in conjunction with a response algorithm to elevated ketone levels. Following a 2-week Run-in they will be randomized 1:1 to either initiate remedial action at ketone levels of: 1) 1.0mmol/L or 2) 1.5mmol/L. They will be followed for 12 weeks. The primary outcome will be % time spent with ketone levels ≥3.0mmol/L with secondary outcomes including % time spent with ketone levels >0.6, >1.0, and >1.5mmol/L, mean interstitial ketone levels, DKA events (n) and behavioral outcomes with comparisons between the two groups. Data from this program of research will substantially advance knowledge of and guide the practical use of a CGKM in preventing DKA in those with T1D treated with SGLTi.


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 = $987,196 )
2025	2025	UNIVERSITY OF MELBOURNE	RAYMOND PRIESTLEY BLDG UNIV OF MELB	MELBOURNE	VICTORIA			AUS	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/11/2025	NEW	$987,196
														Subtotal = $987,196

Grand Total All Awards = $987,196

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The Evaluation of Two Response Thresholds to Continuous Ketone Monitoring Information Minimising Ketosis in People with Type 1 Diabetes Treated with Sotagliflozin.

Award Number: U01DK143330

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: 09/12/2025

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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