{
  "id": "AIBD-0295",
  "title": "Dexcom G6's “Urgent Low Soon” predictive alert may cut time below 54 mg/dL, by less in controlled trials",
  "summary": "Dexcom-authored analyzes (1,424 and 15,000 users) link the 20-minute predictive low alert to less hypoglycemia; an independent 24-person crossover RCT found a reduction only below 2.8 mmol/L.",
  "date_observed": "2019-03-22",
  "date_basis": "unassessed",
  "date_precision": "unassessed",
  "benefit_status": null,
  "source_collection": null,
  "source_entry": null,
  "account": "The Dexcom G6 continuous glucose monitor was classified by the Food and Drug Administration (FDA) under De Novo DEN170088 on 27 March 2018. Its “Urgent Low Soon” (ULS) alert fires when an algorithm predicts an estimated glucose value of 55 mg/dL or below within 20 minutes. Dexcom employees Puhr, Derdzinski, Welsh, Parker, Walker and Price compared 1,424 users before and after moving from the G5 (no predictive alert) to the G6. Their anonymized comparison was in Diabetes Technology & Therapeutics (online 22 March 2019). With a 70 mg/dL low-threshold setting (n=658) time below 54 mg/dL fell from 1.0% to 0.6%. With an 80 mg/dL setting (n=766) it fell 0.6% to 0.4% (both P<0.001). ULS fired 0.9 and 0.6 times a day. A second Dexcom analysis (Puhr et al., Journal of Diabetes Science and Technology, online 3 April 2019; abstract only) had 15,000 G6 app users. More than 93% had ULS enabled. Its use was associated with less time below 55 and 70 mg/dL regardless of how often users viewed the app. The FDA decision summary describes the threshold and predictive alerts as intended to warn patients to act before a hypoglycemic event. Independent evidence is thinner. The PACE crossover randomized trial at Imperial College Healthcare NHS Trust had 24 adults with type 1 diabetes. Each had ULS on or off for 40 days. It found no difference in hypoglycemia below 3.0 or 3.9 mmol/L in the 24 hours after exercise. Time below 2.8 mmol/L was lower with ULS on (P=0.04). Preechasuk et al. (Imperial College London) had 29 adults who switched from FreeStyle Libre 2 to a Dexcom G7 with ULS. They spent less time below 70 mg/dL (3.0% to 2.0%, P=0.006). That changes device and alert together. A Prague case report records a patient with impaired hypoglycemia awareness whose CGM with ULS on did not eliminate prolonged hypoglycemia. He sometimes muted the alerts. None of the sources calls the predictive algorithm machine learning.",
  "category": "general benefit",
  "unexpected": false,
  "purpose": "Built to warn users 20 minutes before predicted serious hypoglycemia so they can act. The reported reductions in time below 54–55 mg/dL are that purpose.",
  "system": "Dexcom G6 real-time continuous glucose monitoring system, 'Urgent Low Soon' predictive low glucose alert (also present on the G7 in one independent study)",
  "model_version": "Dexcom G6 (vendor analyses; PACE trial); Dexcom G7 (Preechasuk et al.)",
  "developer": "Dexcom, Inc.",
  "deployer": null,
  "location": "United States (vendor analyzes); London, United Kingdom (independent trials)",
  "domain": "Healthcare (diabetes technology)",
  "segment": "Diabetes technology",
  "benefit_type": "Improved Physical Health",
  "taxonomy_note": null,
  "registry_ids": {},
  "ratings": [
    {
      "group": "personal",
      "depth": null,
      "reason": "Reductions in time below 54–55 mg/dL are reported for user populations, mostly in Dexcom's own analyses. No individual event with a changed outcome is documented. The one independent case report found ULS alone insufficient."
    },
    {
      "group": "organizational",
      "depth": null,
      "reason": "No payer, clinic or health-system outcome is reported in the sources."
    }
  ],
  "ai_role": {
    "status": "assessed",
    "statement": "The alert is generated when the G6 algorithm forecasts glucose at or below 55 mg/dL within 20 minutes. Users still have to act on it. The principal outcome evidence is the maker's own real-world analyses (Puhr et al. 2019, 2020). They compare the same users before and after the G6 transition without a control arm. The independent Imperial College PACE randomized trial found no difference at 3.0 or 3.9 mmol/L after exercise and a difference only below 2.8 mmol/L. The Imperial switch study cannot separate the alert from the change of device. None of the sources describes the prediction method as machine learning."
  },
  "evidence": [
    {
      "kind": "peer-reviewed study",
      "citation": "Puhr S, Derdzinski M, Welsh JB, Parker AS, Walker T, Price DA (2019). Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert. Diabetes Technology & Therapeutics 21(4):155-158 (PMC6477579). All authors at Dexcom, Inc.",
      "title": "Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/",
      "date": "2019-03-22",
      "written_by": "makers",
      "quote": "includes a new alert that is triggered when an algorithm predicts that an estimated glucose value ≤55 mg/dL will occur within 20 min"
    },
    {
      "kind": "peer-reviewed study",
      "citation": "Puhr et al. (2019), Diabetes Technol Ther 21(4):155-158, results.",
      "title": "Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/",
      "date": "2019-03-22",
      "written_by": "makers",
      "quote": "Percent time <54, ≤55, <70, and >250 mg/dL fell significantly after the transition to G6, independent of low threshold alert setting."
    },
    {
      "kind": "peer-reviewed study",
      "citation": "Puhr S, Derdzinski M, Parker AS, Welsh JB, Price DA (2020). Real-World Hypoglycemia Avoidance With a Predictive Low Glucose Alert Does Not Depend on Frequent Screen Views. Journal of Diabetes Science and Technology 14(1) (online 3 April 2019; PMC7189147). All authors at Dexcom, Inc.",
      "title": "Real-World Hypoglycemia Avoidance With a Predictive Low Glucose Alert Does Not Depend on Frequent Screen Views",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7189147/",
      "date": "2019-04-03",
      "written_by": "makers",
      "quote": "Over 93% of users enabled the ULS alert; its use was associated with significantly reduced hypoglycemia <55 and <70 mg/dL, independent of screen view frequency."
    },
    {
      "kind": "regulatory document",
      "citation": "U.S. Food and Drug Administration (2018). Evaluation of Automatic Class III Designation for Dexcom G6 Continuous Glucose Monitoring System, Decision Summary, DEN170088 (decision date 27 March 2018).",
      "title": "De Novo DEN170088 Decision Summary: Dexcom G6 Continuous Glucose Monitoring System",
      "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170088.pdf",
      "date": "2018-03-27",
      "written_by": "independent",
      "quote": "An adjustable threshold and predictive glucose alert at 55 mg/dL are intended to warn patients that they need to take action",
      "supports_benefit": false
    },
    {
      "kind": "peer-reviewed study",
      "citation": "Rilstone S, Oliver N, Godsland I, Tanushi B, Thomas M, Hill N (2024). A Randomized Controlled Trial Assessing the Impact of Continuous Glucose Monitoring with a Predictive Hypoglycemia Alert Function on Hypoglycemia in Physical Activity for People with Type 1 Diabetes (PACE). Diabetes Technology & Therapeutics 26(2); doi:10.1089/dia.2023.0376.",
      "title": "A Randomized Controlled Trial Assessing the Impact of Continuous Glucose Monitoring with a Predictive Hypoglycemia Alert Function on Hypoglycemia in Physical Activity for People with Type 1 Diabetes (PACE)",
      "url": "https://doi.org/10.1089/dia.2023.0376",
      "date": "2023-11-27",
      "written_by": "independent",
      "quote": "There was no difference in change from baseline of hypoglycemia <3.0 and <3.9 mmol/L with the ULS on or off during the 24 h after exercise."
    },
    {
      "kind": "peer-reviewed study",
      "citation": "Preechasuk L, Avari P, Oliver N, Reddy M (2024). Switching from Intermittently Scanned Continuous Glucose Monitoring to Real-Time Continuous Glucose Monitoring with a Predictive Urgent Low Soon Alert Reduces Exposure to Hypoglycemia. Diabetes Technology & Therapeutics 26(7); doi:10.1089/dia.2023.0434.",
      "title": "Switching from Intermittently Scanned Continuous Glucose Monitoring to Real-Time Continuous Glucose Monitoring with a Predictive Urgent Low Soon Alert Reduces Exposure to Hypoglycemia",
      "url": "https://doi.org/10.1089/dia.2023.0434",
      "date": "2024-04-09",
      "written_by": "independent",
      "quote": "After switching to rtCGM, participants spent less time in hypoglycemia below 3.9 mmol/L (70 mg/dL) (3.0% [1.0%, 5.0%] vs. 2.0% [1.0%, 3.0%], P = 0.006)"
    }
  ],
  "replication": {
    "produced_by": [
      "Real-time CGM with the ULS alert enabled (over 93% of G6 app users in Dexcom's sample)",
      "Users who respond to the alert by treating or adjusting insulin, which the sources assume rather than measure",
      "A low-threshold alert also set (70 or 80 mg/dL in the Dexcom analysis)"
    ],
    "must_hold": [
      "Users keep the alert on rather than muting it for alarm fatigue, as the Prague patient sometimes did",
      "Sensor accuracy sufficient to avoid nuisance alerts, which Puhr et al. cite as a cause of CGM discontinuation",
      "Benefit beyond a plain threshold alert, which the PACE trial found only below 2.8 mmol/L"
    ],
    "echoes": [
      {
        "date": "2023-11-27",
        "setting": "PACE crossover randomized trial, Imperial College Healthcare NHS Trust, 24 adults with type 1 diabetes, ULS on versus off for 40 days each around regular exercise",
        "model_version": "Dexcom G6",
        "outcome": "recurred",
        "source": "Rilstone et al. (2024) Diabetes Technol Ther, doi:10.1089/dia.2023.0376 (significant only for time below 2.8 mmol/L)"
      },
      {
        "date": "2024-04-09",
        "setting": "Imperial College London, 29 adults with type 1 diabetes switched from FreeStyle Libre 2 to Dexcom G7 with ULS for 12 weeks",
        "model_version": "Dexcom G7",
        "outcome": "recurred",
        "source": "Preechasuk et al. (2024) Diabetes Technol Ther, doi:10.1089/dia.2023.0434 (device and alert changed together)"
      },
      {
        "date": "2025-02-21",
        "setting": "Case report, General University Hospital Prague: a 45-year-old man with impaired hypoglycemia awareness used CGM with ULS on during 2020",
        "model_version": null,
        "outcome": "did not recur",
        "source": "Zadáková E, Horová E (2025) Front Clin Diabetes Healthc 6:1536038, https://pmc.ncbi.nlm.nih.gov/articles/PMC11886589/ (quote: 'prolonged hypoglycemia could not be eliminated during 2020, especially after physical activity. The patient admitted that he occasionally had to turn off or mute the alerts')"
      }
    ]
  },
  "paired_incident": null,
  "headline": "Dexcom G6's Urgent Low Soon alert may cut time below 54 mg/dL",
  "metric": "time below 54 mg/dL fell from 1.0% to 0.6%",
  "comparator": {
    "against": "the same users on the preceding Dexcom G5 system, which had no predictive alert (before-and-after)",
    "before": "1.0 (1.5) percent of time <54 mg/dL on G5 (70 mg/dL low-alert setting, Table 1)",
    "after": "0.6 (1.0) percent of time <54 mg/dL on G6 (70 mg/dL low-alert setting, Table 1)",
    "basis": "measured",
    "quote": "Percent time <54, ≤55, <70, and >250 mg/dL fell significantly after the transition to G6, independent of low threshold alert setting. Time in range improved for G6 users with a low threshold alert setting of 70 mg/dL.",
    "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/"
  },
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  "value": null,
  "developer_country": "United States",
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      "date": "2026-10-20",
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    {
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      "change": "Headline reworded to state the event without naming who claims it.",
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      "editor": "AIBD"
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    {
      "date": "2026-10-21",
      "change": "Title reworded to state the event without naming who claims it.",
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      "editor": "AIBD"
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    {
      "date": "2026-10-21",
      "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Knowledge Discovery among the six first used.",
      "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/",
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      "date": "2026-10-21",
      "change": "Added what the benefit is measured against from the cited sources.",
      "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/",
      "editor": "AIBD"
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      "date": "2026-10-21",
      "change": "Country of the developer added from the organization's own site or a registry.",
      "source": "https://en.wikipedia.org/wiki/Dexcom",
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      "date": "2026-10-25",
      "change": "Reviewed the specified original sources; corrected their authorship, document types, and support for the reported benefit.",
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  "confidence": "studied",
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  "claim_status": "Independently studied",
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        "coverage": "partial",
        "family": "evaluations",
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          "answer": "time below 54 mg/dL fell from 1.0% to 0.6%",
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        }
      },
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        "state": "not_assessed",
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        "state": "not_assessed",
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        "state": "not_assessed",
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        "state": "not_assessed",
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        "state": "not_assessed",
        "review_state": "not_assessed",
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            "id": "AIBD-0295"
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        },
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        "review_state": "record_mapped",
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      },
      "infrastructure_dependencies[]": {
        "state": "not_assessed",
        "review_state": "not_assessed",
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        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
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        "state": "not_assessed",
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          "kind": "record_fields",
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            "benefit_type": "Improved Physical Health"
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        },
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      "outcomes[].claim": {
        "state": "value_present",
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          "kind": "record_fields",
          "fields": {
            "account": "The Dexcom G6 continuous glucose monitor was classified by the Food and Drug Administration (FDA) under De Novo DEN170088 on 27 March 2018. Its “Urgent Low Soon” (ULS) alert fires when an algorithm predicts an estimated glucose value of 55 mg/dL or below within 20 minutes. Dexcom employees Puhr, Derdzinski, Welsh, Parker, Walker and Price compared 1,424 users before and after moving from the G5 (no predictive alert) to the G6. Their anonymized comparison was in Diabetes Technology & Therapeutics (online 22 March 2019). With a 70 mg/dL low-threshold setting (n=658) time below 54 mg/dL fell from 1.0% to 0.6%. With an 80 mg/dL setting (n=766) it fell 0.6% to 0.4% (both P<0.001). ULS fired 0.9 and 0.6 times a day. A second Dexcom analysis (Puhr et al., Journal of Diabetes Science and Technology, online 3 April 2019; abstract only) had 15,000 G6 app users. More than 93% had ULS enabled. Its use was associated with less time below 55 and 70 mg/dL regardless of how often users viewed the app. The FDA decision summary describes the threshold and predictive alerts as intended to warn patients to act before a hypoglycemic event. Independent evidence is thinner. The PACE crossover randomized trial at Imperial College Healthcare NHS Trust had 24 adults with type 1 diabetes. Each had ULS on or off for 40 days. It found no difference in hypoglycemia below 3.0 or 3.9 mmol/L in the 24 hours after exercise. Time below 2.8 mmol/L was lower with ULS on (P=0.04). Preechasuk et al. (Imperial College London) had 29 adults who switched from FreeStyle Libre 2 to a Dexcom G7 with ULS. They spent less time below 70 mg/dL (3.0% to 2.0%, P=0.006). That changes device and alert together. A Prague case report records a patient with impaired hypoglycemia awareness whose CGM with ULS on did not eliminate prolonged hypoglycemia. He sometimes muted the alerts. None of the sources calls the predictive algorithm machine learning.",
            "benefit_type": "Improved Physical Health"
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        "review_state": "record_mapped",
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        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
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      "outcomes[].duration": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
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      "outcomes[].id": {
        "state": "not_assessed",
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        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "ratings": [
              {
                "group": "personal",
                "reason": "Reductions in time below 54–55 mg/dL are reported for user populations, mostly in Dexcom's own analyses. No individual event with a changed outcome is documented. The one independent case report found ULS alone insufficient."
              },
              {
                "group": "organizational",
                "reason": "No payer, clinic or health-system outcome is reported in the sources."
              }
            ]
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
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        },
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        "state": "not_assessed",
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        "coverage": "partial"
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        "state": "not_assessed",
        "review_state": "not_assessed",
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      "outcomes[].unexpected": {
        "state": "value_present",
        "value": {
          "kind": "record_fields",
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            "purpose": "Built to warn users 20 minutes before predicted serious hypoglycemia so they can act. The reported reductions in time below 54–55 mg/dL are that purpose."
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        },
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        },
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        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "location": "United States (vendor analyzes); London, United Kingdom (independent trials)",
            "developer_country": "United States"
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
          "record_fields": [
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            "developer_country"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      },
      "purpose": {
        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "purpose": "Built to warn users 20 minutes before predicted serious hypoglycemia so they can act. The reported reductions in time below 54–55 mg/dL are that purpose."
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
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          "kind": "record_fields",
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            "date_observed": "2019-03-22",
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                "date": "2026-10-20",
                "change": "Record drafted from the cited sources.",
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              },
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                "date": "2026-10-21",
                "change": "Headline reworded to state the event without naming who claims it.",
                "editor": "AIBD"
              },
              {
                "date": "2026-10-21",
                "change": "Title reworded to state the event without naming who claims it.",
                "editor": "AIBD"
              },
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                "date": "2026-10-21",
                "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Knowledge Discovery among the six first used.",
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                "editor": "AIBD"
              },
              {
                "date": "2026-10-21",
                "change": "Added what the benefit is measured against from the cited sources.",
                "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/",
                "editor": "AIBD"
              },
              {
                "date": "2026-10-21",
                "change": "Country of the developer added from the organization's own site or a registry.",
                "source": "https://en.wikipedia.org/wiki/Dexcom",
                "editor": "AIBD"
              },
              {
                "date": "2026-10-21",
                "change": "Prose pass: a rating reason, account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.",
                "editor": "AIBD"
              },
              {
                "date": "2026-10-25",
                "change": "Reviewed the specified original sources; corrected their authorship, document types, and support for the reported benefit.",
                "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/",
                "editor": "AIBD"
              }
            ]
          }
        },
        "provenance": {
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          "kind": "record_fields",
          "fields": {
            "replication": {
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                "Real-time CGM with the ULS alert enabled (over 93% of G6 app users in Dexcom's sample)",
                "Users who respond to the alert by treating or adjusting insulin, which the sources assume rather than measure",
                "A low-threshold alert also set (70 or 80 mg/dL in the Dexcom analysis)"
              ],
              "must_hold": [
                "Users keep the alert on rather than muting it for alarm fatigue, as the Prague patient sometimes did",
                "Sensor accuracy sufficient to avoid nuisance alerts, which Puhr et al. cite as a cause of CGM discontinuation",
                "Benefit beyond a plain threshold alert, which the PACE trial found only below 2.8 mmol/L"
              ],
              "echoes": [
                {
                  "date": "2023-11-27",
                  "setting": "PACE crossover randomized trial, Imperial College Healthcare NHS Trust, 24 adults with type 1 diabetes, ULS on versus off for 40 days each around regular exercise",
                  "model_version": "Dexcom G6",
                  "outcome": "recurred",
                  "source": "Rilstone et al. (2024) Diabetes Technol Ther, doi:10.1089/dia.2023.0376 (significant only for time below 2.8 mmol/L)"
                },
                {
                  "date": "2024-04-09",
                  "setting": "Imperial College London, 29 adults with type 1 diabetes switched from FreeStyle Libre 2 to Dexcom G7 with ULS for 12 weeks",
                  "model_version": "Dexcom G7",
                  "outcome": "recurred",
                  "source": "Preechasuk et al. (2024) Diabetes Technol Ther, doi:10.1089/dia.2023.0434 (device and alert changed together)"
                },
                {
                  "date": "2025-02-21",
                  "setting": "Case report, General University Hospital Prague: a 45-year-old man with impaired hypoglycemia awareness used CGM with ULS on during 2020",
                  "outcome": "did not recur",
                  "source": "Zadáková E, Horová E (2025) Front Clin Diabetes Healthc 6:1536038, https://pmc.ncbi.nlm.nih.gov/articles/PMC11886589/ (quote: 'prolonged hypoglycemia could not be eliminated during 2020, especially after physical activity. The patient admitted that he occasionally had to turn off or mute the alerts')"
                }
              ]
            }
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
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          "kind": "record_fields",
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            "replication": {
              "produced_by": [
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                "A low-threshold alert also set (70 or 80 mg/dL in the Dexcom analysis)"
              ],
              "must_hold": [
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                "Sensor accuracy sufficient to avoid nuisance alerts, which Puhr et al. cite as a cause of CGM discontinuation",
                "Benefit beyond a plain threshold alert, which the PACE trial found only below 2.8 mmol/L"
              ],
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                },
                {
                  "date": "2024-04-09",
                  "setting": "Imperial College London, 29 adults with type 1 diabetes switched from FreeStyle Libre 2 to Dexcom G7 with ULS for 12 weeks",
                  "model_version": "Dexcom G7",
                  "outcome": "recurred",
                  "source": "Preechasuk et al. (2024) Diabetes Technol Ther, doi:10.1089/dia.2023.0434 (device and alert changed together)"
                },
                {
                  "date": "2025-02-21",
                  "setting": "Case report, General University Hospital Prague: a 45-year-old man with impaired hypoglycemia awareness used CGM with ULS on during 2020",
                  "outcome": "did not recur",
                  "source": "Zadáková E, Horová E (2025) Front Clin Diabetes Healthc 6:1536038, https://pmc.ncbi.nlm.nih.gov/articles/PMC11886589/ (quote: 'prolonged hypoglycemia could not be eliminated during 2020, especially after physical activity. The patient admitted that he occasionally had to turn off or mute the alerts')"
                }
              ]
            }
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        },
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        },
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                "kind": "peer-reviewed study",
                "citation": "Puhr S, Derdzinski M, Welsh JB, Parker AS, Walker T, Price DA (2019). Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert. Diabetes Technology & Therapeutics 21(4):155-158 (PMC6477579). All authors at Dexcom, Inc.",
                "title": "Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert",
                "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/",
                "date": "2019-03-22",
                "written_by": "makers",
                "quote": "includes a new alert that is triggered when an algorithm predicts that an estimated glucose value ≤55 mg/dL will occur within 20 min"
              },
              {
                "kind": "peer-reviewed study",
                "citation": "Puhr et al. (2019), Diabetes Technol Ther 21(4):155-158, results.",
                "title": "Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert",
                "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6477579/",
                "date": "2019-03-22",
                "written_by": "makers",
                "quote": "Percent time <54, ≤55, <70, and >250 mg/dL fell significantly after the transition to G6, independent of low threshold alert setting."
              },
              {
                "kind": "peer-reviewed study",
                "citation": "Puhr S, Derdzinski M, Parker AS, Welsh JB, Price DA (2020). Real-World Hypoglycemia Avoidance With a Predictive Low Glucose Alert Does Not Depend on Frequent Screen Views. Journal of Diabetes Science and Technology 14(1) (online 3 April 2019; PMC7189147). All authors at Dexcom, Inc.",
                "title": "Real-World Hypoglycemia Avoidance With a Predictive Low Glucose Alert Does Not Depend on Frequent Screen Views",
                "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7189147/",
                "date": "2019-04-03",
                "written_by": "makers",
                "quote": "Over 93% of users enabled the ULS alert; its use was associated with significantly reduced hypoglycemia <55 and <70 mg/dL, independent of screen view frequency."
              },
              {
                "kind": "regulatory document",
                "citation": "U.S. Food and Drug Administration (2018). Evaluation of Automatic Class III Designation for Dexcom G6 Continuous Glucose Monitoring System, Decision Summary, DEN170088 (decision date 27 March 2018).",
                "title": "De Novo DEN170088 Decision Summary: Dexcom G6 Continuous Glucose Monitoring System",
                "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170088.pdf",
                "date": "2018-03-27",
                "written_by": "independent",
                "quote": "An adjustable threshold and predictive glucose alert at 55 mg/dL are intended to warn patients that they need to take action",
                "supports_benefit": false
              },
              {
                "kind": "peer-reviewed study",
                "citation": "Rilstone S, Oliver N, Godsland I, Tanushi B, Thomas M, Hill N (2024). A Randomized Controlled Trial Assessing the Impact of Continuous Glucose Monitoring with a Predictive Hypoglycemia Alert Function on Hypoglycemia in Physical Activity for People with Type 1 Diabetes (PACE). Diabetes Technology & Therapeutics 26(2); doi:10.1089/dia.2023.0376.",
                "title": "A Randomized Controlled Trial Assessing the Impact of Continuous Glucose Monitoring with a Predictive Hypoglycemia Alert Function on Hypoglycemia in Physical Activity for People with Type 1 Diabetes (PACE)",
                "url": "https://doi.org/10.1089/dia.2023.0376",
                "date": "2023-11-27",
                "written_by": "independent",
                "quote": "There was no difference in change from baseline of hypoglycemia <3.0 and <3.9 mmol/L with the ULS on or off during the 24 h after exercise."
              },
              {
                "kind": "peer-reviewed study",
                "citation": "Preechasuk L, Avari P, Oliver N, Reddy M (2024). Switching from Intermittently Scanned Continuous Glucose Monitoring to Real-Time Continuous Glucose Monitoring with a Predictive Urgent Low Soon Alert Reduces Exposure to Hypoglycemia. Diabetes Technology & Therapeutics 26(7); doi:10.1089/dia.2023.0434.",
                "title": "Switching from Intermittently Scanned Continuous Glucose Monitoring to Real-Time Continuous Glucose Monitoring with a Predictive Urgent Low Soon Alert Reduces Exposure to Hypoglycemia",
                "url": "https://doi.org/10.1089/dia.2023.0434",
                "date": "2024-04-09",
                "written_by": "independent",
                "quote": "After switching to rtCGM, participants spent less time in hypoglycemia below 3.9 mmol/L (70 mg/dL) (3.0% [1.0%, 5.0%] vs. 2.0% [1.0%, 3.0%], P = 0.006)"
              }
            ]
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
          "record_fields": [
            "evidence"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      },
      "sources[].id": {
        "state": "value_present",
        "value": {
          "kind": "identifiers",
          "identifiers": [
            "AIBD-0295-source-0001",
            "AIBD-0295-source-0002",
            "AIBD-0295-source-0003",
            "AIBD-0295-source-0004",
            "AIBD-0295-source-0005",
            "AIBD-0295-source-0006"
          ],
          "role": "Existing evidence items, in their original order"
        },
        "provenance": {
          "kind": "curatorial",
          "basis": "Stable within the fingerprinted record version; no source content or source review has been added.",
          "record_fields": [],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "complete"
      },
      "sources[].language": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
      },
      "sources[].relationship": {
        "state": "value_present",
        "value": {
          "kind": "text",
          "text": "FDA cleared the G6 after reviewing its performance. The later studies assess hypoglycemia. The controlled PACE trial found no difference on its primary comparison and a benefit on a secondary measure."
        },
        "provenance": {
          "kind": "source_review",
          "basis": "The identified originals and their locators are listed in the source assessment.",
          "record_fields": [],
          "source_refs": [
            "AIBD-0295-source-0004",
            "AIBD-0295-source-0005"
          ],
          "reviewed_on": "2026-10-25"
        },
        "review_state": "reviewed",
        "coverage": "partial",
        "display": {
          "answer": "FDA cleared the G6 after reviewing its performance. The later studies assess hypoglycemia. The controlled PACE trial found no difference on its primary comparison and a benefit on a secondary measure."
        }
      },
      "sources[].upstream_sources": {
        "state": "value_present",
        "value": {
          "kind": "structured",
          "data": {
            "reviewed_on": "2026-10-25",
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              "AIBD-0295-source-0001",
              "AIBD-0295-source-0002",
              "AIBD-0295-source-0003",
              "AIBD-0295-source-0004",
              "AIBD-0295-source-0005",
              "AIBD-0295-source-0006"
            ],
            "origins": [
              {
                "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170088.pdf",
                "locator": "§ L(3), pp. 13–14; §§ S–T, pp. 38–39.",
                "contribution": "Sensor-performance evidence, the alert’s intended function, and the clearance decision.",
                "relationship": "FDA’s regulatory review predates the outcome studies.",
                "source_refs": [
                  "AIBD-0295-source-0004"
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              },
              {
                "url": "https://journals.sagepub.com/doi/10.1089/dia.2023.0376",
                "locator": "Study design, Results, and Discussion.",
                "contribution": "A controlled comparison of alerts on and off; the primary hypoglycemia comparison was null, with a favorable secondary result.",
                "relationship": "Original randomized study; distinct from clearance.",
                "source_refs": [
                  "AIBD-0295-source-0005"
                ]
              }
            ],
            "excluded_or_consolidated_sources": [],
            "review_scope": "Whether the specified sources establish the reported benefit, their document types, and their authorship relationships. Other fields and sources were not comprehensively reassessed."
          }
        },
        "provenance": {
          "kind": "source_review",
          "basis": "A limited source-role review; each inspected source and its contribution is identified.",
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          "source_refs": [
            "AIBD-0295-source-0004",
            "AIBD-0295-source-0005"
          ],
          "reviewed_on": "2026-10-25"
        },
        "review_state": "reviewed",
        "coverage": "partial",
        "display": {
          "answer": "FDA cleared the G6 after reviewing its performance. The later studies assess hypoglycemia. The controlled PACE trial found no difference on its primary comparison and a benefit on a secondary measure."
        }
      },
      "strategic_assessments[]": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial",
        "family": "strategic assessments"
      },
      "summary": {
        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "summary": "Dexcom-authored analyzes (1,424 and 15,000 users) link the 20-minute predictive low alert to less hypoglycemia; an independent 24-person crossover RCT found a reduction only below 2.8 mmol/L.",
            "account": "The Dexcom G6 continuous glucose monitor was classified by the Food and Drug Administration (FDA) under De Novo DEN170088 on 27 March 2018. Its “Urgent Low Soon” (ULS) alert fires when an algorithm predicts an estimated glucose value of 55 mg/dL or below within 20 minutes. Dexcom employees Puhr, Derdzinski, Welsh, Parker, Walker and Price compared 1,424 users before and after moving from the G5 (no predictive alert) to the G6. Their anonymized comparison was in Diabetes Technology & Therapeutics (online 22 March 2019). With a 70 mg/dL low-threshold setting (n=658) time below 54 mg/dL fell from 1.0% to 0.6%. With an 80 mg/dL setting (n=766) it fell 0.6% to 0.4% (both P<0.001). ULS fired 0.9 and 0.6 times a day. A second Dexcom analysis (Puhr et al., Journal of Diabetes Science and Technology, online 3 April 2019; abstract only) had 15,000 G6 app users. More than 93% had ULS enabled. Its use was associated with less time below 55 and 70 mg/dL regardless of how often users viewed the app. The FDA decision summary describes the threshold and predictive alerts as intended to warn patients to act before a hypoglycemic event. Independent evidence is thinner. The PACE crossover randomized trial at Imperial College Healthcare NHS Trust had 24 adults with type 1 diabetes. Each had ULS on or off for 40 days. It found no difference in hypoglycemia below 3.0 or 3.9 mmol/L in the 24 hours after exercise. Time below 2.8 mmol/L was lower with ULS on (P=0.04). Preechasuk et al. (Imperial College London) had 29 adults who switched from FreeStyle Libre 2 to a Dexcom G7 with ULS. They spent less time below 70 mg/dL (3.0% to 2.0%, P=0.006). That changes device and alert together. A Prague case report records a patient with impaired hypoglycemia awareness whose CGM with ULS on did not eliminate prolonged hypoglycemia. He sometimes muted the alerts. None of the sources calls the predictive algorithm machine learning."
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
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          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      },
      "systems[].autonomy_permissions": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
      },
      "systems[].component_role": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
      },
      "systems[].deployment_configuration": {
        "state": "value_present",
        "value": {
          "kind": "text",
          "text": "The vendor analyses and PACE trial used Dexcom G6 devices. The Preechasuk study used Dexcom G7 devices."
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Separated the model, software, hardware, or operation already described in the existing record. No new source review is claimed.",
          "record_fields": [
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            "system",
            "ai_role"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      },
      "systems[].inputs_outputs": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
      },
      "systems[].model_name": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
      },
      "systems[].model_version": {
        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "model_version": "Dexcom G6 (vendor analyses; PACE trial); Dexcom G7 (Preechasuk et al.)"
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
          "record_fields": [
            "model_version"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial",
        "display": {
          "answer": "Exact release not established.",
          "editor_note": ""
        }
      },
      "systems[].product_name": {
        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "system": "Dexcom G6 real-time continuous glucose monitoring system, 'Urgent Low Soon' predictive low glucose alert (also present on the G7 in one independent study)"
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
          "record_fields": [
            "system"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      },
      "systems[].provider": {
        "state": "value_present",
        "value": {
          "kind": "structured",
          "data": {
            "application_developer": "Dexcom, Inc."
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Mapped from the existing case description without a new external source review.",
          "record_fields": [
            "developer"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      },
      "taxonomy_crosswalks[]": {
        "state": "not_assessed",
        "review_state": "not_assessed",
        "coverage": "partial"
      },
      "title": {
        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "title": "Dexcom G6's “Urgent Low Soon” predictive alert may cut time below 54 mg/dL, by less in controlled trials",
            "headline": "Dexcom G6's Urgent Low Soon alert may cut time below 54 mg/dL"
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
          "record_fields": [
            "title",
            "headline"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      },
      "version": {
        "state": "value_present",
        "value": {
          "kind": "identifiers",
          "identifiers": [
            "a22b940e01e867889b7fa5921506d0d0cd267ddfe3653c464b81e87b76a1a6f2"
          ],
          "role": "SHA-256 of normalized original case data"
        },
        "provenance": {
          "kind": "curatorial",
          "basis": "Deterministic content version assigned by the local migration.",
          "record_fields": [],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "complete"
      },
      "workflow": {
        "state": "value_present",
        "value": {
          "kind": "record_fields",
          "fields": {
            "account": "The Dexcom G6 continuous glucose monitor was classified by the Food and Drug Administration (FDA) under De Novo DEN170088 on 27 March 2018. Its “Urgent Low Soon” (ULS) alert fires when an algorithm predicts an estimated glucose value of 55 mg/dL or below within 20 minutes. Dexcom employees Puhr, Derdzinski, Welsh, Parker, Walker and Price compared 1,424 users before and after moving from the G5 (no predictive alert) to the G6. Their anonymized comparison was in Diabetes Technology & Therapeutics (online 22 March 2019). With a 70 mg/dL low-threshold setting (n=658) time below 54 mg/dL fell from 1.0% to 0.6%. With an 80 mg/dL setting (n=766) it fell 0.6% to 0.4% (both P<0.001). ULS fired 0.9 and 0.6 times a day. A second Dexcom analysis (Puhr et al., Journal of Diabetes Science and Technology, online 3 April 2019; abstract only) had 15,000 G6 app users. More than 93% had ULS enabled. Its use was associated with less time below 55 and 70 mg/dL regardless of how often users viewed the app. The FDA decision summary describes the threshold and predictive alerts as intended to warn patients to act before a hypoglycemic event. Independent evidence is thinner. The PACE crossover randomized trial at Imperial College Healthcare NHS Trust had 24 adults with type 1 diabetes. Each had ULS on or off for 40 days. It found no difference in hypoglycemia below 3.0 or 3.9 mmol/L in the 24 hours after exercise. Time below 2.8 mmol/L was lower with ULS on (P=0.04). Preechasuk et al. (Imperial College London) had 29 adults who switched from FreeStyle Libre 2 to a Dexcom G7 with ULS. They spent less time below 70 mg/dL (3.0% to 2.0%, P=0.006). That changes device and alert together. A Prague case report records a patient with impaired hypoglycemia awareness whose CGM with ULS on did not eliminate prolonged hypoglycemia. He sometimes muted the alerts. None of the sources calls the predictive algorithm machine learning.",
            "replication": {
              "produced_by": [
                "Real-time CGM with the ULS alert enabled (over 93% of G6 app users in Dexcom's sample)",
                "Users who respond to the alert by treating or adjusting insulin, which the sources assume rather than measure",
                "A low-threshold alert also set (70 or 80 mg/dL in the Dexcom analysis)"
              ],
              "must_hold": [
                "Users keep the alert on rather than muting it for alarm fatigue, as the Prague patient sometimes did",
                "Sensor accuracy sufficient to avoid nuisance alerts, which Puhr et al. cite as a cause of CGM discontinuation",
                "Benefit beyond a plain threshold alert, which the PACE trial found only below 2.8 mmol/L"
              ],
              "echoes": [
                {
                  "date": "2023-11-27",
                  "setting": "PACE crossover randomized trial, Imperial College Healthcare NHS Trust, 24 adults with type 1 diabetes, ULS on versus off for 40 days each around regular exercise",
                  "model_version": "Dexcom G6",
                  "outcome": "recurred",
                  "source": "Rilstone et al. (2024) Diabetes Technol Ther, doi:10.1089/dia.2023.0376 (significant only for time below 2.8 mmol/L)"
                },
                {
                  "date": "2024-04-09",
                  "setting": "Imperial College London, 29 adults with type 1 diabetes switched from FreeStyle Libre 2 to Dexcom G7 with ULS for 12 weeks",
                  "model_version": "Dexcom G7",
                  "outcome": "recurred",
                  "source": "Preechasuk et al. (2024) Diabetes Technol Ther, doi:10.1089/dia.2023.0434 (device and alert changed together)"
                },
                {
                  "date": "2025-02-21",
                  "setting": "Case report, General University Hospital Prague: a 45-year-old man with impaired hypoglycemia awareness used CGM with ULS on during 2020",
                  "outcome": "did not recur",
                  "source": "Zadáková E, Horová E (2025) Front Clin Diabetes Healthc 6:1536038, https://pmc.ncbi.nlm.nih.gov/articles/PMC11886589/ (quote: 'prolonged hypoglycemia could not be eliminated during 2020, especially after physical activity. The patient admitted that he occasionally had to turn off or mute the alerts')"
                }
              ]
            }
          }
        },
        "provenance": {
          "kind": "legacy_record",
          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
          "record_fields": [
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          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      }
    },
    "summary": {
      "total": 91,
      "addressed": 91,
      "known": 30,
      "reviewed": 2,
      "record_mapped": 28,
      "not_assessed": 61,
      "complete": false,
      "by_state": {
        "value_present": 30,
        "not_reported": 0,
        "unresolved": 0,
        "not_assessed": 61,
        "not_applicable": 0,
        "withheld": 0,
        "source_unavailable": 0
      }
    }
  }
}