The glucose-ketone sensor will be the same size as Abbott’s FreeStyle Libre 3 sensor, the world’s smallest and thinnest 1.2 continuous glucose monitoring (CGM) sensor and will connect to Abbott’s digital ecosystem, including personal and mobile apps for caregivers and cloud-based data management software for remote monitoring by healthcare professionals.
Need for continuous glucose ketone monitoring
Continuous glucose ketone monitoring is especially important for people with diabetes, who may be at higher risk of developing diabetic ketoacidosis (DKA), a potentially life-threatening condition when blood ketone levels rise to dangerous levels.
DKA is a growing problem worldwide. 3 In the US alone, there are hundreds of thousands of emergency room visits and hospitalizations for DKA each year. 4 Yet few people with diabetes now regularly monitor their ketones because current testing methods — typically through blood or urine — are costly 5 and distressing. 6 Adding continuous ketone monitoring to a continuous glucose monitoring system eliminates the need for a separate ketone test.
Recent studies show that continuous ketone monitoring (CKM) could help prevent DKA. 3 With continuous monitoring, rising ketone levels can be identified early as a warning of impending ketoacidosis and informed medical care to prevent DKA from developing. Leading diabetes experts have called for an expansion of ketone monitoring, including integration with CGM technology in a single sensor. 7.8 Uncontrolled ketone levels can pose serious risks for people with diabetes, especially children and young adults with type 1 diabetes. 7
“In my practice, I have seen numerous cases of DKA in teenagers and children that could have been prevented with continuous ketone monitoring,” said Dr. Kurt Midyett , pediatric endocrinologist and medical director at Midwest Pediatric Specialists in Overland Park, Kansas. “Giving people with diabetes the ability to continuously monitor both glucose and ketones in a single, intuitive device is an important step in diabetes care, as it will allow patients to identify rising ketone levels and intervene before a full one DKA developed.”
“DKA remains a critical problem for too many people with type 1 diabetes. We applaud Abbott for addressing this issue — one that JDRF is also committed to,” he said Aaron J Kowalski , Ph.D., Chief Executive Officer of JDRF. “JDRF supports the development of CGM/CKM systems like the one Abbott is developing. CGM/CKMs will be key to reducing the incidence of DKA in the diabetic population Wider adoption and safe, effective use of sodium-glucose co-transporter (SGLT) inhibitors SGLT inhibitors improve blood glucose and are believed to improve cardiac and renal outcomes Improve people with type 1 diabetes but have been held back because they increase risk of DKA. ”
Availability and Interoperability
Abbott is already conducting clinical studies on the glucose ketone monitoring system. Registration studies will take place in 2023, after which regulatory filings are to follow.
Abbott plans to partner with leading insulin pump manufacturers to make the dual monitoring system compatible with insulin delivery systems.
Abbott currently has the most widely used CGM in the world 9 . Abbott’s FreeStyle Libre portfolio has already transformed the lives of approximately 4 million people in 60 countries 9 by delivering breakthrough technologies that are accessible and affordable. 10
Abbott is a leading global healthcare company that helps people live more fulfilling lives at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading companies and products in diagnostics, medical devices, nutrition and branded generics. Our 113,000 colleagues serve people in more than 160 countries.
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1 Data on file, Abbott Diabetes Care.
2 Below the sensors attached to the patient.
3 Cherubini, V., Grimsmann, JM, Åkesson, K. et al. Temporal trends of diabetic ketoacidosis at diagnosis of pediatric type 1 diabetes between 2006 and 2016: results from 13 countries on three continents. Diabetologia 63, 1530-1541 (2020).
4 National Diabetes Statistics Report 2020, estimates of diabetes and its burden in The United States (2020). https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed May 5, 2022 .
5 Albanese-O’Neill A, Wu M, Miller KM, et al. Poor adherence to ketone testing in patients with type 1 diabetes. diabetes treatment . 2017;40(4):e38-e39.
6 Dhatariya K. Blood ketones: measurement, interpretation, limitations, and utility in the management of diabetic ketoacidosis. Rev. Diabetes Stud . 2016;13(4):217-225.
7 Nguyen KT, Xu NY, Zhang JY, et al. 2021 Continuous Ketone Monitoring Consensus Report. Journal of Diabetes Science and Technology . October 2021 .
8th Lee MH, Paldus B, Krishnamurthy B, et al. The clinical case for the integration of a ketone sensor as part of a closed insulin pump system. J Diabetes Sci Technol . 2019;13(5):967-973.
9 Data on file, Abbott Diabetes Care. Data is based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users of other leading sensor-based personal glucose monitoring systems.
10 Based on a list price comparison of the FreeStyle Libre portfolio to competitor CGM systems available worldwide. Actual cost to patients may be lower than other CGM systems, depending on local reimbursement, if any.
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