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Development of CGMs with Continuous Ketone Monitoring Functionality for DKA Prevention in T1D

Deadlines are 5:00 PM (Eastern). No extensions will be granted.


Milestone Date Status
Letter of Intent Required Jul 29, 2021 Passed
Application Sep 30, 2021 Passed
Award Notification Mar 31, 2022 Next
Earliest Start May 01, 2022

Background & Purpose

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PURPOSE

JDRF is committed to the development of devices to improve health outcomes in people with type 1 diabetes (T1D). Diabetic ketoacidosis (DKA) is a dangerous acute complication of T1D that is insufficiently addressed or even sometimes exacerbated by current therapeutic options. To fill this gap, JDRF invites applications to develop continuous ketone monitor (CKM) functionality in continuous glucose monitor (CGM) devices to warn users of impending DKA events and allow preventive actions to be taken.

BACKGROUND

DKA is an acute complication of T1D in which insulin deficiency leads to elevated blood ketones and acidosis, sometimes resulting in diabetic coma or even death. A cause of morbidity and mortality for people with T1D, DKA also imposes significant costs to healthcare systems due to associated hospitalizations. Avoidance of DKA requires symptom recognition and self-monitoring of ketones using commercially available blood or urine strips, tools that are poorly adopted and sometimes cost-prohibitive. Continuous, automatic monitoring of ketones is expected to identify more approaching DKA events than the current ketone testing regimens. This RFA is intended to drive development of combined CGM-CKM devices, i.e. CGMs that also continuously measure ketones. This functionality will allow for continuous testing of ketones with no additional on-body burden. We envision CGM-CKM devices that alert users when ketones have reached an elevated but subclinical threshold, allowing them to administer conventional self-care before a DKA event is imminent or contact a health care provider when needed. At the same time, to optimize user experience, we recommend CGM-CKMs that require minimal user engagement with ketone readings during periods of normal ketone levels.