AI system
- System
-
Medtronic MiniMed sensor-augmented pump / automated insulin delivery with predictive low glucose suspend (SmartGuard)
- Model
-
Not assessed
- Release
-
Exact release not established.
- Application developer
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Medtronic
- Role
-
The pump predicted low glucose and suspended insulin delivery.
- Configuration
-
The initial event involved a MiniMed 640G. A later report involved a MiniMed 780G.
- Inputs and outputs
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Not assessed
- Autonomy
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Not assessed
- Workflow
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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.
- Human oversight
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Not assessed
- Relation to AI
-
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.
- AI contribution
-
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.
Benefits
- Outcome identifiers
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Not assessed
- Benefit
-
hypoglycemic episodes fell from 2.1–2.5 to 1.4 per day
- Category
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Improved Physical Health
- Status
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Not assessed
- Beneficiary groups
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People.
- Beneficiaries
-
Not assessed
- Reach
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Not assessed
- Distribution and access
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Not assessed
- Duration
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Not assessed
- Expected?
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Yes
- Costs and harms
-
Not assessed
Measurement
- Studies
-
Not assessed
- Study design
-
Not assessed
- Measurement
-
Not assessed
- Setting and sample
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Not assessed
- Measures
-
hypoglycemic episodes fell from 2.1–2.5 to 1.4 per day
- Comparison
-
her two earlier pregnancies on a MiniMed 620G sensor-augmented pump without predictive low glucose suspend
- Results
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Reference: Hypoglycemic episodes (/day) 2.5 and 2.1; time with AUC below 70 mg/dL 1.1% and 1.4%. Result: Hypoglycemic episodes (/day) 1.4; mean AUC < 70 mg/dL of 0.5%.
- Additional value from AI
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Not assessed
- Limitations
-
Not assessed
- Denominators
-
Not assessed
- Materials for replication
-
Not assessed
Money
- Kind of value
-
Not assessed
- Amount
-
Not assessed
- Currency and prices
-
Not assessed
- Period and unit
-
Not assessed
- Realization
-
Not assessed
- Recipients and payers
-
Not assessed
- Gross or net
-
Not assessed
- Included costs
-
Not assessed
- Comparison
-
Not assessed
- Method
-
Not assessed
- Return and payback
-
Not assessed
People and places
- Participants
-
Developer: Medtronic.
- Jurisdictions
-
Developer:
Ireland. - Ownership and control
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Not assessed
- Dependencies
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Not assessed
- Cross-border connections
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Not assessed
- Geopolitical implications
-
Not assessed
Follow-up
- Conditions for replication
-
Sensor is worn and calibrated with suspend enabled. The user does not override suspensions. Clinical follow-up adjusts settings.
- Replication attempts
-
1 follow-up entries. Benefit recurred: 1.
- Later findings
-
No development for this patient after the 2021 case report was found; the 2025 MiniMed 780G report concerns a different patient.
- Availability
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Not assessed
- Institutional decision
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Not assessed
- Grounds
-
Not assessed
- Action and result
-
Not assessed
- Success criterion
-
Not assessed
Evidence
- Source numbers
-
AIBD-0028-source-0001–0003
- Citations
-
Numbered references below.
- Language
-
Not assessed
- Source relationships
-
Operator
- Original evidence
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Not assessed
- Access and versions
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Not assessed
- Supported findings
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Not assessed
- Evidence links
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Not assessed
- Evidence strength
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Not assessed
- Missing evidence
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Not assessed
Grades
- Assessed benefits
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People.
- Depth
-
People: 3.
- Reasons
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People: 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.
- Observed or intended
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Not assessed
- Rubric
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Not assessed
- Assessor and date
-
Not assessed
- Alternative assessments
-
Not assessed
- Fill
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The deployer's account
Entry details
- Kind
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Not assessed
- Related entries
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Not assessed
- Field
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Healthcare (diabetes; obstetrics). Diabetes technology.
- 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.
- Dates
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Date basis unassessed: 2021 (precision unassessed). Updated: 21 October 2026.
- Stage
-
Not assessed
- Version
-
SHA-256: bc612c5c94bf…
References
- Other identifiers
-
Not assessed
- Category mappings
-
Not assessed
- Brief
-
Not assessed
- Revisions
-
4 revisions. Latest: 21 October 2026.
Sources
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Case report Deployer
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.
She gave birth to a 4137 g boy at 39 weeks without significant complications.
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Case report Deployer
Honoki H et al. (2021). Diabetology International 12:324-329.
SAP-PLGS makes it possible to avoid severe hypoglycemia following the compensation of insulin to mitigate transient hyperglycemia.
-
Case report Deployer
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.
since the initiation of the AID, there has been no episode of severe hypoglycemia