Concept: closed loops that act on ketones
What it is
What we should build — the sensor half now exists (Abbott's Libre Duo, the first dual glucose-and-ketone wearable, CE-marked in Europe in May 2026 and FDA-authorized as Libre Duo 10 Day on 25 August 2026), but no automated insulin delivery system reads the ketone channel and no standard says how one should respond. Until an algorithm can see ketones climbing and act, a dual sensor is a warning light nobody is wired to.
Editorial review: .
Most recent recorded citation date: 2026-08-25. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Read the reported benefits in the full discussion. Effect sizes and study limitations are described there.
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Unranked design concept
This entry describes desired features and related research. It has no product-performance score or ranking. Named products and research programmes have their own evidence records.
Editor’s take
We used to rank this as the most important sensing upgrade on the roadmap. Abbott has now built the sensor — so the argument moves one layer up. Ketone blindness is why a kinked cannula can escalate to the ER, and a continuous ketone channel turns that from emergency into early warning only if something is listening. Today nothing is: no closed loop consumes ketones, and no standard defines what it should do when they climb. That algorithm, not the sensor, is now the thing we would fund.
The full picture
This entry used to argue for a sensor. That argument has been won: Abbott's Libre Duo reads glucose and ketones from one wearable, every minute, took a CE Mark in Europe in May 2026, and the 10-day version received FDA De Novo authorization on 25 August 2026 — authorization, not a launch, and still not a loop that acts.235 So the concept moves up a layer, to the half that nobody has built.
The remaining gap: nothing is listening. When an infusion site fails or illness strikes, ketones (beta-hydroxybutyrate) can climb toward diabetic ketoacidosis — sometimes while glucose still looks reassuring. In a reported case, a wearable ketone monitor caught exactly that: sustained ketosis above 1.0 mmol/L for 14 hours while CGM showed normal glucose.7 Today the best a dual sensor can do is tell you. As of this cutoff, no commercial automated insulin delivery (AID) system reads a ketone channel, and no published standard defines what a loop should do when it sees one rising — increase basal, prompt an injection and a site change, refuse to trust the pump, or simply escalate loudly.4 A warning light is only worth as much as the thing wired to it.
What we want built. A loop that treats ketones as a first-class input: it notices ketones rising while glucose creeps up, infers "this insulin is not getting in", stops quietly compensating, and tells you to change the site and inject by pen — the reasoning a person does today, done automatically and potentially hours earlier. The prerequisites are a published accuracy figure for the ketone channel (you cannot let an algorithm act on a signal whose error bars are unpublished), an agreed action policy, and a regulator willing to clear it. As of this cutoff, no published accuracy figure, agreed action policy, or clearance for such a loop exists.
Who is actually building the sensing side. Abbott led first with the Libre Duo — CE-marked, then US-authorized as a 10-day sensor, still not a commercial launch as of this cutoff.235 PercuSense was reported as starting two Helmsley-funded type 1 diabetes studies in summer 2026, measuring glucose, lactate, ketones and tissue oxygen from a single probe.4 Biolinq is reported to be adding lactate, with ketones and cortisol under consideration.4 Dexcom has said it will ship potassium first (around 2027-2028) and ketones after.4 Sequel has a public agreement to connect its twiist AID system to Abbott's dual sensor, and Abbott has announced plans for twiist and iLet pairings by the end of 2026 — the closest anyone has come to closing this loop, and still a company plan rather than a product, with no published rule for what the loop would actually do about a rising ketone.65 The multi-analyte hardware race is real and crowded; the algorithm race has not started.
The cited review reports an international expert consensus calling for precisely this class of sensor, noting poor adherence to fingerstick ketone testing and the risk of ketosis at normal glucose levels with SGLT2 inhibitors.1 A registered McGill trial (NCT06753994) is studying continuous ketone monitoring in people with type 1 diabetes using SGLT2 inhibitors.8 We keep this as a concept to hold the unbuilt half visible — the sensing is arriving, the intelligence is not.
Coming soon
ETA · The sensor is real: Libre Duo is CE-marked in Europe (May 2026) and the 10-day version is FDA-authorized (25 August 2026). Neither market has a commercial launch as of this cutoff. A closed loop that acts on the ketone channel has no timeline.
- →Sensor half delivered — Abbott's Libre Duo took the CE Mark in May 2026 and US De Novo authorization of Libre Duo 10 Day on 25 August 2026; neither is a launch, and no loop yet acts on the ketone channel
- →More analytes coming — PercuSense was reported as starting two Helmsley-funded type 1 studies in summer 2026 sensing glucose, lactate, ketones and tissue oxygen on one probe; Dexcom has said it plans potassium first and ketones after
- →Still missing — as of this cutoff, no automated insulin delivery system consumes a ketone channel, and no published standard defines how a loop should respond to rising ketones
Sources
- [1]Prevalence, Cost, and Burden of Diabetic Ketoacidosis · Peer-reviewed study — Reports an international expert consensus recommending a continuous ketone monitoring system, ideally one combining CGM with 3-β-OHB in a single sensor; also documents poor adherence to fingerstick ketone testing and euglycemic DKA risk with SGLT2 inhibitors.
Virdi N, Poon Y, Abaniel R, Bergenstal RM. Prevalence, Cost, and Burden of Diabetic Ketoacidosis. Diabetes Technol Ther (2023).
- [2]Abbott secures CE Mark for world's first dual glucose-ketone sensing technology for people with diabetes · Manufacturer — Libre Duo measures glucose and ketones every minute for early DKA warning; CE-marked May 2026. US De Novo of the 10-day version followed on 25 August 2026 — authorization, not a launch.
Abbott. Abbott secures CE Mark for world's first dual glucose-ketone sensing technology for people with diabetes. Abbott Media Room (2026).
- [3]Abbott receives CE mark for dual glucose-ketone sensor · Science journalism — MedTech Dive, 27 May 2026 — independent confirmation of the CE mark, wear and age specs, and phased EU launch. US review is no longer pending: the 10-day version was De Novo authorized on 25 August 2026.
Reuter E. Abbott receives CE mark for dual glucose-ketone sensor. MedTech Dive (2026).
- [4]4 diabetes tech execs on the future of multi-analyte glucose sensors · Science journalism · 2026-06-22 — MedTech Dive, 22 June 2026 — PercuSense is starting two Helmsley-funded type 1 diabetes studies in summer 2026 measuring glucose, lactate, ketones and tissue oxygen on a single probe; Biolinq is adding lactate with ketones and cortisol under consideration; Dexcom plans potassium first (2027-2028) and ketones after.
MedTech Dive. 4 diabetes tech execs on the future of multi-analyte glucose sensors (2026).
- [5]FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar · Regulatory decision · 2026-08-25 — US De Novo of Libre Duo 10 Day for ages 2+. Sensor authorization is not a closed-loop indication and is not a commercial launch.
U.S. FDA. FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar (25 August 2026).
- [6]Sequel Med Tech to Integrate twiist Automated Insulin Delivery (AID) System with Abbott's Future Dual Glucose-Ketone Sensor · Manufacturer — Sequel/GlobeNewswire, 22 May 2025 — an agreement to integrate the twiist AID system with Abbott's dual sensor once US-cleared. An intention, not a shipping product; no published policy for how the loop would act on ketones.
Sequel Med Tech. Sequel Med Tech to Integrate twiist Automated Insulin Delivery (AID) System with Abbott's Future Dual Glucose-Ketone Sensor. GlobeNewswire (2025).
- [7]Continuous Ketone Monitoring Captures Overt Ketosis in Type 1 Diabetes Caused by Empagliflozin, Low-Carbohydrate Diet, and Exercise · Peer-reviewed study — Wearable continuous ketone monitor detected sustained ketosis (>1.0 mmol/L for 14 h) while CGM showed euglycemia — exactly the blind spot glucose-only sensing misses.
Continuous Ketone Monitoring Captures Overt Ketosis in Type 1 Diabetes Caused by Empagliflozin, Low-Carbohydrate Diet, and Exercise. Journal of Diabetes Science and Technology (2026).
- [8]Continuous Ketone Monitoring in Participants With Type 1 Diabetes Using SGLT2 Inhibitors as Adjunctive Therapy (NCT06753994) · Trial registry — McGill University trial evaluating wearable continuous ketone monitoring in T1D.
Continuous Ketone Monitoring in Participants With Type 1 Diabetes Using SGLT2 Inhibitors as Adjunctive Therapy (NCT06753994). ClinicalTrials.gov.