{"stable_id":"13efd27ef861d7ae","slug":"type2-automated-insulin-delivery","company":"2IQP multicenter trial / Tandem Diabetes Care","workflow_name":"CGM-driven automated insulin delivery","function_code":"clinical_ops","pattern_codes":["autonomous_with_backstop","continuous_decisioning"],"changed_assumption":"Bounded closed-loop control can adjust insulin while patients and clinicians retain targets and safety response.","evidence_strength":"verified","publication_tier":"showcase","freshness":"current","reviewed_at":"2026-08-23","updated_at":"2026-08-22","source_quality_summary":"1 independent, 1 peer reviewed; publication outcomes are verified.","caveat_summary":"Open device intervention funded by Tandem; one severe hypoglycemia event occurred in the AID group.","freshness_caveat":null,"workflow_summary":{"before":[{"actor":"Patient","action":"Uses the pretrial insulin-delivery method and continuous glucose information to manage insulin.","actor_type":"human"},{"actor":"Patient and diabetes clinician","action":"Adjust therapy using ordinary care and respond to high/low glucose.","actor_type":"human"}],"hinge":"Bounded closed-loop control can adjust insulin while patients and clinicians retain targets and safety response.","after":[{"actor":"Automated insulin-delivery algorithm","action":"Uses CGM data to modulate insulin delivery between patient interactions.","actor_type":"ai"},{"actor":"Patient and clinician","action":"Manage meals, device operation, supplies, alarms, and clinical review.","actor_type":"human"}],"decision_mode":"bounded_autonomy","decision_marker":"AI acts within a human backstop"},"before":[{"order":1,"actor":"Patient","action":"Uses the pretrial insulin-delivery method and continuous glucose information to manage insulin.","handoff_to":"Insulin pump/injection and clinician","control":"Control participants continued pretrial delivery and received CGM; the article does not impose one manual dosing sequence."},{"order":2,"actor":"Patient and diabetes clinician","action":"Adjust therapy using ordinary care and respond to high/low glucose.","handoff_to":"Ongoing care","control":"Clinical oversight and hypoglycemia safety plan."}],"after":[{"order":1,"actor":"Automated insulin-delivery algorithm","action":"Uses CGM data to modulate insulin delivery between patient interactions.","handoff_to":"Insulin pump","control":"Configured glucose targets, pump limits, CGM availability, and safety alarms."},{"order":2,"actor":"Patient and clinician","action":"Manage meals, device operation, supplies, alarms, and clinical review.","handoff_to":"Ongoing care or safety escalation","control":"Humans retain treatment enrollment and emergency response; severe events follow trial safety procedures."}],"decision_rights":"The algorithm controls bounded dose delivery; patients and clinicians retain therapy selection, targets, and safety response.","exception_path":"Sensor/pump failure, alarms, hypoglycemia, or unsuitable conditions revert to manual safety procedures.","removed_work":["Repeated routine dose calculations between clinical reviews"],"outcomes":[{"metric":"HbA1c","baseline":"8.2% AID and 8.1% control","result":"7.3% AID vs 7.7% control at week 13; adjusted difference −0.6 percentage points","period":"13 weeks","scale":"319 randomized adults with insulin-treated type 2 diabetes","attribution_caveat":"Open device intervention funded by Tandem; one severe hypoglycemia event occurred in the AID group.","evidence_label":"verified"}],"executive_lesson":"Automating a frequent decision can improve outcomes when authority boundaries and safety fallback are explicit.","anti_pattern":"Do not infer that autonomous dosing removes patient workload or severe-event risk.","questions_for_leaders":["Where is the operating threshold set and who can override it?","What measured result would trigger rollback or retraining?","Which residual decisions must remain human-owned?"],"collections":["regulated-autonomy"],"bundle_version":"1.0.0","bundle_fingerprint":"sha256:c23c6cc2b88153d008ea8fda928f632ce0011fc2d4c5036672a16e5d895bab93","canonical_url":"https://brianletort.ai/transformations/type2-automated-insulin-delivery"}