---
title: '2IQP multicenter trial / Tandem Diabetes Care: CGM-driven automated insulin delivery'
slug: type2-automated-insulin-delivery
stable_id: 13efd27ef861d7ae
company: 2IQP multicenter trial / Tandem Diabetes Care
function_code: clinical_ops
pattern_codes:
  - autonomous_with_backstop
  - continuous_decisioning
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.
collections:
  - regulated-autonomy
bundle_version: 1.0.0
bundle_fingerprint: sha256:c23c6cc2b88153d008ea8fda928f632ce0011fc2d4c5036672a16e5d895bab93
canonical_url: https://brianletort.ai/transformations/type2-automated-insulin-delivery
---

# 2IQP multicenter trial / Tandem Diabetes Care: CGM-driven automated insulin delivery

Bounded closed-loop control can adjust insulin while patients and clinicians retain targets and safety response.

Function: Clinical operations. Patterns: Autonomous with a backstop; Continuous decisioning. Evidence: verified.

Freshness: current. Reviewed: 2026-08-23. Updated: 2026-08-22.


Source quality: 1 independent, 1 peer reviewed; publication outcomes are verified.

## Before

1. **Patient** — Uses the pretrial insulin-delivery method and continuous glucose information to manage insulin. (control: Control participants continued pretrial delivery and received CGM; the article does not impose one manual dosing sequence.)
2. **Patient and diabetes clinician** — Adjust therapy using ordinary care and respond to high/low glucose. (control: Clinical oversight and hypoglycemia safety plan.)

## After

1. **Automated insulin-delivery algorithm** — Uses CGM data to modulate insulin delivery between patient interactions. (control: Configured glucose targets, pump limits, CGM availability, and safety alarms.)
2. **Patient and clinician** — Manage meals, device operation, supplies, alarms, and clinical review. (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.

## Outcomes

- **HbA1c** (verified): 8.2% AID and 8.1% control → 7.3% AID vs 7.7% control at week 13; adjusted difference −0.6 percentage points. Open device intervention funded by Tandem; one severe hypoglycemia event occurred in the AID group.

## 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?

## Sources

- [A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes](https://www.nejm.org/doi/full/10.1056/NEJMoa2415948) — New England Journal of Medicine
- [A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes](https://pubmed.ncbi.nlm.nih.gov/40105270/) — PubMed / U.S. National Library of Medicine