{
  "id": "AIBD-0028",
  "title": "Medtronic MiniMed predictive low-glucose suspend reducing hypoglycemia with a successful pregnancy",
  "summary": "MiniMed 640G predictive low-glucose suspend cut hypoglycemia in a T1D woman after two miscarriages; term birth of a 4,137 g boy.",
  "date_observed": "2021-03-06",
  "date_basis": "unassessed",
  "date_precision": "unassessed",
  "benefit_status": null,
  "source_collection": null,
  "source_entry": null,
  "account": "A case report appeared in Diabetology International on 6 March 2021 (event dates not reported). It describes a 22-year-old Brazilian woman in Japan with type 1 diabetes for 11 years. She miscarried at 7 and 9 weeks in two earlier pregnancies. At about 6 weeks of her third pregnancy she was switched to a Medtronic MiniMed 640G sensor-augmented pump with predictive low glucose suspend. The pump suspended insulin for about 249 minutes per day. Hypoglycemic episodes fell from 2.1–2.5 to 1.4 per day and time below 70 mg/dL from 1.1–1.4% to 0.5%. She delivered a 4,137 g boy by cesarean section at 39 weeks and 3 days with no significant complications.",
  "category": "benefit created",
  "unexpected": false,
  "purpose": "Predictive low glucose suspend is built to stop insulin delivery when sensor glucose is predicted to fall low, to avoid hypoglycemia. The benefit was that purpose, with a successful pregnancy as the downstream outcome.",
  "system": "Medtronic MiniMed sensor-augmented pump / automated insulin delivery with predictive low glucose suspend (SmartGuard)",
  "model_version": "MiniMed 640G (event); MiniMed 780G in echo",
  "developer": "Medtronic",
  "deployer": null,
  "location": null,
  "domain": "Healthcare (diabetes; obstetrics)",
  "segment": "Diabetes technology",
  "benefit_type": "Improved Physical Health",
  "taxonomy_note": null,
  "registry_ids": {},
  "ratings": [
    {
      "group": "personal",
      "depth": 3,
      "reason": "After two miscarriages, hypoglycemia frequency and glucose variability fell on the device and the pregnancy reached term with a healthy infant. A life-changing benefit, though the source does not prove the device caused the live birth."
    }
  ],
  "ai_role": {
    "status": "assessed",
    "statement": "The pump's predictive algorithm autonomously suspended insulin for about four hours a day. The authors link this to fewer hypoglycemic episodes and lower variability. Obstetric and diabetes care were delivered by clinicians. The causal link to carrying the pregnancy is inferred, not demonstrated."
  },
  "evidence": [
    {
      "kind": "case report",
      "citation": "Honoki H, Yagi K, Tsuda S, Wada T, Enkaku A, Nakagawa-Yokoyama M, Kamigishi M, Shikata M, Takikawa-Nishida A, Fujisaka S, Chujo D, Sasaoka T, Nakashima A, Saito S, Tobe K (2021). Type 1 diabetes woman with repeated miscarriages successfully gave birth after introducing an insulin pump with a predictive low glucose suspend feature. Diabetology International 12:324-329.",
      "title": "Type 1 diabetes woman with repeated miscarriages successfully gave birth after introducing an insulin pump with a predictive low glucose suspend feature",
      "url": "https://doi.org/10.1007/s13340-020-00489-9",
      "date": "2021-03-06",
      "written_by": "deployer",
      "quote": "She gave birth to a 4137 g boy at 39 weeks without significant complications."
    },
    {
      "kind": "case report",
      "citation": "Honoki H et al. (2021). Diabetology International 12:324-329.",
      "title": "Type 1 diabetes woman with repeated miscarriages successfully gave birth after introducing an insulin pump with a predictive low glucose suspend feature",
      "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8172753/",
      "date": "2021-03-06",
      "written_by": "deployer",
      "quote": "SAP-PLGS makes it possible to avoid severe hypoglycemia following the compensation of insulin to mitigate transient hyperglycemia."
    },
    {
      "kind": "case report",
      "citation": "Zadáková E, Horová E (2025). Case Report: Hybrid closed-loop insulin pump can significantly improve awareness of hypoglycemia. Frontiers in Clinical Diabetes and Healthcare 6:1536038.",
      "title": "Hybrid closed-loop insulin pump can significantly improve awareness of hypoglycemia",
      "url": "https://europepmc.org/article/PMC/PMC11886589",
      "date": "2025-02-21",
      "written_by": "deployer",
      "quote": "since the initiation of the AID, there has been no episode of severe hypoglycemia"
    }
  ],
  "replication": {
    "produced_by": [
      "A person with type 1 diabetes and frequent or unrecognized hypoglycemia uses a Medtronic pump with CGM and predictive low glucose suspend enabled",
      "Sensor glucose is predicted to fall and the algorithm suspends basal insulin",
      "Hypoglycemia frequency and variability fall and the clinical goal (pregnancy, restored awareness) is reached"
    ],
    "must_hold": [
      "Sensor is worn and calibrated with suspend enabled",
      "The user does not override suspensions",
      "Clinical follow-up adjusts settings"
    ],
    "echoes": [
      {
        "date": "2025-02-21",
        "setting": "45-year-old man with type 1 diabetes since 1996 and impaired hypoglycemia awareness, Czechia; MiniMed 780G SmartGuard started mid-2021 after his driving license was suspended in April 2021; no severe hypoglycemia since, Clarke and Gold scores 6 to 2 by early 2022, license reinstated, time below range 23% to 1% by June 2024 (publication date)",
        "model_version": "Medtronic MiniMed 780G (SmartGuard)",
        "outcome": "recurred",
        "source": "Zadáková & Horová (2025). Front Clin Diabetes Healthc 6:1536038. https://pmc.ncbi.nlm.nih.gov/articles/PMC11886589/"
      }
    ]
  },
  "paired_incident": null,
  "headline": "MiniMed 640G cuts hypoglycemia; mother delivers a 4,137 g boy",
  "metric": "hypoglycemic episodes fell from 2.1–2.5 to 1.4 per day",
  "comparator": {
    "against": "her two earlier pregnancies on a MiniMed 620G sensor-augmented pump without predictive low glucose suspend",
    "before": "Hypoglycemic episodes (/day) 2.5 and 2.1; time with AUC below 70 mg/dL 1.1% and 1.4%",
    "after": "Hypoglycemic episodes (/day) 1.4; mean AUC < 70 mg/dL of 0.5%",
    "basis": "measured",
    "quote": "Ratio of time range with average AUC blow 70 mg/dL (%) 1.1 1.4 0.5 Hypoglycemic episodes (/day) 2.5 2.1 1.4",
    "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8172753/"
  },
  "later": {
    "status": "unknown",
    "date": null,
    "note": "No development for this patient after the 2021 case report was found; the 2025 MiniMed 780G report concerns a different patient.",
    "quote": null,
    "url": null
  },
  "value": null,
  "developer_country": "Ireland",
  "deployer_country": null,
  "unrated_because": null,
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    {
      "date": "2026-10-20",
      "change": "Record drafted from the cited sources.",
      "source": null,
      "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 Accessibility among the six first used.",
      "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/",
      "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/Medtronic",
      "editor": "AIBD"
    },
    {
      "date": "2026-10-21",
      "change": "Prose pass: a rating reason, account, purpose, the replication conditions, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.",
      "source": null,
      "editor": "AIBD"
    }
  ],
  "confidence": "claimed",
  "shade": "low",
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          "basis": "Preserved from the existing AIBD record; external sources were not rechecked.",
          "record_fields": [
            "account",
            "replication"
          ],
          "source_refs": []
        },
        "review_state": "record_mapped",
        "coverage": "partial"
      }
    },
    "summary": {
      "total": 91,
      "addressed": 91,
      "known": 32,
      "reviewed": 0,
      "record_mapped": 32,
      "not_assessed": 59,
      "complete": false,
      "by_state": {
        "value_present": 32,
        "not_reported": 0,
        "unresolved": 0,
        "not_assessed": 59,
        "not_applicable": 0,
        "withheld": 0,
        "source_unavailable": 0
      }
    }
  }
}