{"id":"d3f4598c-3c0a-4a99-a235-d0d94eebf947","companyId":"fd5648f6-a93c-460e-918c-021449c44e97","modelName":"Stelo","slug":"stelo","description":"Stelo by Dexcom is a continuous glucose monitor biosensor and the glucose-biometric entry in the cohort, recorded in the biometric form factor as a boundary include because glucose is in the biometric definition and Stelo pairs an FDA-cleared sensor with a genuine generative-AI insight layer rather than being a bare sensor readout. Made by DexCom (NASDAQ: DXCM) as a product line separate from its prescription G7 monitors, Stelo is the first-ever FDA-cleared over-the-counter, no-prescription continuous glucose biosensor, cleared via De Novo announced on March 5, 2024 and launched in the US on August 26, 2024 for adults 18 and older who are not on insulin, including people with type 2 diabetes not on insulin and non-diabetic users tracking the impact of diet and exercise, with a 15-day wear and no low-glucose alerts since it is not cleared for problematic hypoglycemia. Its AI augmentation is genuine: Dexcom launched a generative-AI platform for Stelo on Google Cloud's Vertex AI and Gemini, providing personalized Weekly Insights, AI photo meal logging, and up to three personalized daily recommendations drawn from glucose, activity, nutrition, and sleep, which is what tips it from a medical sensor to an in-definition biometric-AI device and fills the glucose cell distinct from the heart-rate and sleep watches and rings. Its FDA clearance makes it the strongest verification anchor of the Wave-2 set, while the marketing claim of being the first generative-AI platform in glucose biosensing is not load-bearing and is not asserted, and its exclusion of low-glucose alerting is recorded as an indication boundary.","formFactor":"biometric","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"Boundary INCLUDE (glucose-biometric + real AI)","value":"Glucose is in the biometric definition; Stelo clears the medical-sensor-without-meaningful-AI exclusion bar: it pairs an FDA-cleared glucose biosensor with a GENUINE generative-AI insight layer (Vertex AI/Gemini Weekly Insights, AI meal photo logging, personalized recommendations from glucose/activity/nutrition/sleep) - not a bare sensor readout. Fills the GLUCOSE cell of the biometric cohort (distinct from the HR/sleep watches+rings)."},{"label":"FDA status (strongest anchor in Wave 2)","value":"First-ever FDA-cleared OTC (no-prescription) continuous glucose biosensor: De Novo clearance announced Mar 5 2024; US launch Aug 26 2024; for adults 18+ not on insulin. The FDA clearance makes it the strongest verification anchor of the Wave-2 set."},{"label":"Cap-flag","value":"'First generative AI platform in glucose biosensing' is Dexcom marketing framing - the CLEARANCE and the Vertex/Gemini integration are verified; the 'first' superlative is not load-bearing, don't assert it. Stelo is NOT cleared for problematic hypoglycemia / no low-glucose alerts (an indication boundary)."}],"specs":"Stelo: continuous glucose monitor (CGM) biosensor, 15-day wear; first-ever FDA-cleared OTC (no-prescription) glucose biosensor (De Novo Mar 5 2024; US launch Aug 26 2024). Indication: adults 18+ NOT on insulin (type 2 not on insulin + non-diabetic users tracking diet/exercise impact); not cleared for problematic hypoglycemia (no low-glucose alerts). Generative-AI: Weekly Insights (Google Cloud Vertex AI + Gemini), AI photo meal logging, personalized daily recommendations. Company: DexCom Inc (NASDAQ: DXCM); Stelo = the OTC product line (separate from prescription G7).","formFactor":"biometric (biometric-primary GLUCOSE biosensor / OTC continuous glucose monitor + generative-AI insights)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx","title":"Stelo by Dexcom: first glucose biosensor FDA-cleared OTC (De Novo Mar 5 2024; adults 18+ not on insulin)","sourceName":"Dexcom (investor relations)"},{"url":"https://investors.dexcom.com/news/news-details/2024/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing/default.aspx","title":"Dexcom launches generative-AI platform for Stelo (Google Cloud Vertex AI + Gemini; Weekly Insights)","sourceName":"Dexcom (investor relations)"},{"url":"https://www.medtechdive.com/news/dexcom-gen-ai-feature-stelo-cgm/735918/","title":"Dexcom gen-AI for Stelo (personalized insights; AI photo meal logging)","sourceName":"MedTech Dive"}],"aliases":["Stelo","Stelo by Dexcom","Stelo Glucose Biosensor"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T22:46:46.520Z","updatedAt":"2026-06-03T22:46:46.520Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/stelo","url":"https://registry.deploy.report/models/stelo","name":"Stelo","alternateName":["Stelo","Stelo by Dexcom","Stelo Glucose Biosensor"],"description":"Stelo by Dexcom is a continuous glucose monitor biosensor and the glucose-biometric entry in the cohort, recorded in the biometric form factor as a boundary include because glucose is in the biometric definition and Stelo pairs an FDA-cleared sensor with a genuine generative-AI insight layer rather than being a bare sensor readout. Made by DexCom (NASDAQ: DXCM) as a product line separate from its prescription G7 monitors, Stelo is the first-ever FDA-cleared over-the-counter, no-prescription continuous glucose biosensor, cleared via De Novo announced on March 5, 2024 and launched in the US on August 26, 2024 for adults 18 and older who are not on insulin, including people with type 2 diabetes not on insulin and non-diabetic users tracking the impact of diet and exercise, with a 15-day wear and no low-glucose alerts since it is not cleared for problematic hypoglycemia. Its AI augmentation is genuine: Dexcom launched a generative-AI platform for Stelo on Google Cloud's Vertex AI and Gemini, providing personalized Weekly Insights, AI photo meal logging, and up to three personalized daily recommendations drawn from glucose, activity, nutrition, and sleep, which is what tips it from a medical sensor to an in-definition biometric-AI device and fills the glucose cell distinct from the heart-rate and sleep watches and rings. Its FDA clearance makes it the strongest verification anchor of the Wave-2 set, while the marketing claim of being the first generative-AI platform in glucose biosensing is not load-bearing and is not asserted, and its exclusion of low-glucose alerting is recorded as an indication boundary.","identifier":"d3f4598c-3c0a-4a99-a235-d0d94eebf947","category":"biometric","publisher":{"@id":"https://deploy.report/#organization"}}}