Continuous ketone monitoring for people with diabetes: international expert recommendations on the application of a new technology
- PMID: 41381175
- DOI: 10.1016/S2213-8587(25)00331-6
Continuous ketone monitoring for people with diabetes: international expert recommendations on the application of a new technology
Abstract
The ability to reduce the risk of developing diabetic ketoacidosis (DKA) remains a major care gap for people with diabetes, particularly those on intensive insulin therapy. The anticipated availability of continuous ketone monitoring (CKM) has the potential to reduce the risk of developing DKA, one of the most life-threatening acute complications of type 1 and type 2 diabetes. International clinical guidelines have established ketone thresholds for suspected and confirmed diagnoses of DKA, based on use of point-of-care testing, as part of a triad of markers with allied thresholds for hyperglycaemia and acidosis. The increasing occurrence of euglycemic DKA, with glucose concentrations below established diagnostic thresholds, makes the availability and use of CKM technology an important addition to the diabetes management toolkit. CKM data could alert the user when the risk of acute DKA is high on sick days in addition to signalling that individuals might be predicted to be at greater overall risk of future DKA on the basis of the distribution and degree of ketone measures in daily life. If widespread use of CKM devices is to be safe and effective in reducing the occurrence of DKA, it is important to establish clear ketone thresholds which notify CKM users when action on their part is required. In defining these thresholds and actions, it was important to ensure that the CKM user is not exposed to avoidable anxiety or suffers alarm fatigue, thus adding to the burden of living with diabetes. In the absence of substantial evidence that can identify appropriate ketone thresholds for CKM use, a panel of international experts in the management of DKA was convened with the aim of developing a number of objective, practical recommendations on how this novel diabetes technology could improve outcomes for individuals at risk of DKA, the results of which we report in this Personal View. These recommendations have been endorsed by the International Society for Pediatric and Adolescent Diabetes (ISPAD).
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Conflict of interest statement
Declaration of interests KD has received payment for lectures and consulting from Abbott, Boehringer Ingelheim, Eli Lilly, Roche Diabetes Care, Sanofi, and AstraZeneca; support for attendance at participation in speakers’ bureaus for Abbott; and was sponsored by Breakthrough T1D to attend the writing group meetings for this manuscript. RMB has received grants or contracts from Abbott, DexCom, Eli Lilly, Embecta, Insulet, Medtronic, Novo Nordisk, Roche Diabetes Care, Tandem Diabetes Care, and Sanofi; consulting fees from Abbott, DexCom, Eli Lilly, Embecta, Novo Nordisk, Roche Diabetes Care, and Sanofi; payment or honoraria from Abbott, DexCom, Novo Nordisk, and Roche Diabetes Care; and support for attending meetings from Abbott, Dexcom, Eli Lilly, Novo Nordisk, and Roche Diabetes Care. RMB's employer, the non-profit HealthPartners Institute, contracts for his services and he receives no personal income from any of these activities. MA-S has received research support from Medtronic and Sanofi; served on advisory panels for Medtronic, Insulet, Abbott, VitalAire, Sanofi, and Dexcom; received honoraria for speaking from Abbott, Eli Lilly, Medtronic, Novo Nordisk, Sanofi, and VitalAire; received support from Medtronic for meeting attendance; and is the Vice President of the Saudi Society of Endocrinology and Metabolism and the Vice President of the Saudi Type 1 Diabetes Association. AA-O’N declares her employer receives grant support from Abbott, Medtronic, Sanofi, Novo Nordisk, and Vertex. TB declares that the institutions he works for (University of Ljubljana and University Children's Hospital–University Medical Centre Ljubljana) has received grants or contracts from Abbott, Medtronic, Novo Nordisk, Sanofi, Novartis, Sandoz, Zealand Pharma, Slovenian Research and Innovation Agency, US National Institutes of Health, Breakthrough T1D, Helmsley Foundation, and the European Union. TB has received payment or honoraria from Eli Lilly, Novo Nordisk, Medtronic, Abbott, Sanofi, Dexcom, Aventis, AstraZeneca, and Roche; and has participated on a data safety monitoring board or advisory board for Novo Nordisk, Sanofi, Eli Lilly, AstraZeneca, Medtronic, Abbott, Roche, SAB Bio, Tandem, and Dexcom. CDB received support (for this manuscript) from Abbott and Indigo Diabetes; consulting fees from Abbott, AstraZeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Indigo Diabetes, Insulet, Medtronic, and Novo Nordisk; and payment or honoraria from Abbott, Eli Lilly and Novo Nordisk. SD is an employee of Breakthrough T1D, and declares that this institution has received payment or honoraria from AstraZeneca, Abbott, Biomedia, Bayer, Boehringer Ingelheim, Dexcom, Eli Lilly, Insulet, Medtronic, Menarini, Novo Nordisk, Roche, Sanofi, Vitalaire, and Ypsomed. RJG declares that his employer has received research grant support from Dexcom, Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. RJG has received consulting fees from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtronic, and Novo Nordisk; and support for attending meetings from Eli Lilly. AH has received grants or contracts from Tandem Diabetes Care and Beta Bionics; has royalties and licenses with BigFoot Biomedical; consulting fees from Eli Lilly and Abbott Diabetes; has received payment or honoraria from SiBio; and has received equipment, materials, drugs, medical writing, gifts, or other services from Eli Lilly, Ypsomed, and Dexcom. DK has received grants or contracts from Abbott, Insulet, Sequel, US National Institutes of Health, and Tandem; consulting fees from Abbott, Dexcom, CeQur, Insulet Structural Therapeutics, Lilly, Novo Nordisk, MannKind Proteomics, and Medtronics Arecor; payment or honoraria (along with support for attending meetings and/or travel) from Abbott CeQur, Tandem, Insulet, Eli Lilly and Novo Nordisk; and has stock options in Pendulum. LML has received support from the US National Institutes of Health (grant number P30DK036836). DMM has received advisory board payments from Abbott, Medtronic, Eli Lilly, Sanofi, Biospex, and Kriya; has participated on data safety monitoring board or advisory board for GoMoms (supported by the US National Institute of Diabetes and Digestive and Kidney Diseases); has an unpaid leadership or fiduciary role at Enable Biosciences; and has received research materials from Dexcom to his institution. CMaf has received grants or contracts to the University Hospital of Verona from Medtronic and Movi; has received payment for lectures from Abbott and Roche; payment for chairing a meeting from Theras; and has received payment for participating on advisory boards for Abbott and Medtronic. CMat serves or has served on advisory panels for Abbott, Bayer, Biomea Fusion, Boehringer Ingelheim, Eli Lilly, Medtronic, Insulet, Novo Nordisk, Novartis, Roche, SAB Bio, Sanofi, and Vertex (financial compensation for these activities has been received by KU Leuven; and research support has been received by KU Leuven from Abbott, Dexcom, Novo Nordisk and Sanofi); serves or has served on a speakers bureau for Eli Lilly, Vertex, Roche, Dexcom, Abbott, Medtronic, Novo Nordisk, Insulet, and Sanofi (financial compensation for these activities has been received by KU Leuven); is president of the European Association for the Study of Diabetes and vice-president of the European Diabetes Forum (all external support of the European Association for the Study of Diabetes is on www.easd.org). EM has received payment or honoraria from Abbott Research, Bayer, Boehringer Ingelheim, Embecta, Corcept, Eli Lilly, Insulet, and Novo Nordisk. MM has participated on a data safety monitoring board or advisory board for Abbott and Sanofi; and declares that the institution they work for (Harvard Medical School) has received grants or contracts from Dexcom. RN declares that his employer, Jikei University, has received grants or contracts from Taisho Pharmaceutical, Ono Pharmaceutical, Mitsubishi Electric Company, Nippon Boehringer Ingelheim, Abbott, Arkely, Kowa, Led, and Sanwa. RN has received payment or honoraria from Sanofi Japan, Medtronic, Nippon Boehringer Ingelheim, Teijin, Kissei Pharmaceutical, Abbott, Eli Lilly Japan, Novo Nordisk, and Astellas Pharma. KN has received consulting fees from Novo Nordisk; payment or honoraria from Dexcom and Abbott; has stock options with Novo Nordisk; and has received equipment, materials, drugs, or other services from Dexcom. KN declares that her institutions (Steno Diabetes Center Copenhagen and University of Copenhagen) have received grants or contracts from Novo Nordisk, Medtronic, Dexcom, and Zealand Pharma; payment or honoraria from Medtronic; and have participated on a data safety monitoring board or advisory board for Medtronic. DNO’N has received research support (materials) from Abbott Diabetes Care; research support (materials and funding) from Medtronic and Insulet; received speakers honoraria from Insulet; and has participated on advisory boards and received speaker honoraria from Medtronic and Abbott Diabetes Care. BAP has received honoraria for educational events from Abbott, Bayer, Dexcom, Insulet, Medtronic, Novo Nordisk, and Sanofi; received funding (paid to institution) from BMO Bank of Montreal and Novo Nordisk for research support; and served as an advisor to Abbott, Dexcom, Insulet, Nephris, Novo Nordisk, Sanofi, and Vertex. ER has received grants or contracts for interpretation of study data, fees for participation on an advisory board, and honoraria for lectures from Abbott Diabetes Care. JR declares that Abbott is providing funds to Breakthrough T1D to participate in an Abbott-led ketosis/DKA project. MS has received consulting fees from Novo Nordisk and Cristalia; honoraria from Novo Nordisk, Pfizer, Abbott, Cristalia, and Medtronic; travel grants from Medtronic and Pfizer; participated on advisory boards for Novo Nordisk, Sanofi, and Abbott; and has a leadership or fiduciary role at the Brazilian Society of Diabetes, Brazilian Society of Endocrinology and Metabolism, and Children with Diabetes Institute. JS has participated on advisory boards for Abbott Diabetes, Cecilia Health, Insulet, Mannkind, Medtronic, StartUp Health T1D Moonshot, and Vertex; is the recipient of grants from Abbott, Dexcom, Breakthrough T1D, Insulet, Medtronic, US National Institutes of Health, and Prevention Bio; declares consulting fees from Abbott, Insulet, Medscape, Medtronic, Vertex, and Ypsomed; and has received support for attending meetings from Vertex. CW has received consulting fees and payment or honoraria from Abbott Diabetes, Eli Lilly, MannKind, and Novo Nordisk; has received support for attending meetings/travel from Abbott Diabetes, Eli Lilly, and Novo Nordisk; holds stock in StartUp Health T1D Moonshot; has participated on a data safety monitoring or advisory board for Fractyl; has been a past President for the Endocrine Society (2020–23); and has received equipment from Abbott Diabetes, Eli Lilly, and Novo Nordisk. TD is the Chief Medical Officer for Breakthrough T1D; has participated on a data safety monitoring board or advisory board for Medtronic and Eli Lilly; and declares that he is the co-founder of DreaMed. TD declares that Breakthrough T1D has received payment or honoraria from AstraZeneca, Abbott, Biomedia, Bayer, Boehringer Ingelheim, Dexcom, Eli Lilly, Insulet, Medtronic, Menarini, Novo Nordisk, Roche, Sanofi, Vitalaire, and Ypsomed. All other authors declare no competing interests.
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