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IDE Software Baseline Overview

Status: Reviewer summary Owner: BionicLoop engineering Last updated: 2026-04-07 12:32 EDT

Purpose

Describe the current investigational software baseline in concise reviewer-facing terms.

This summary is not the full architecture or design history. It is the short-form software/device description for the current IDE software packet.

Current Baseline

  • Working baseline commit for this packet: b302dd3
  • Freeze-time baseline SHA is still to be filled at actual package freeze

Software Under Review

The investigational controller is an iPhone application composed of:

  • BionicLoop app UI and orchestration layer
  • BionicLoopCore runtime, domain, persistence, and algorithm-host logic
  • embedded LoopKit support code
  • embedded G7SensorKit integration for Dexcom G7 data intake
  • embedded OmniBLE integration for Omnipod DASH pump communication
  • the bridged dosing algorithm and supporting runtime telemetry/persistence surfaces

Intended Investigational Operating Model

The accepted baseline is a phone-controlled automated insulin-delivery workflow using:

  • Dexcom G7 CGM data as the live glucose input
  • Omnipod DASH as the insulin-delivery device
  • BionicLoop as the controller/runtime/alerting UI

Current operating assumptions and boundaries:

  • closed-loop guardrail remains algorithm-driven dosing only; there is no manual test-dose path
  • meal announcement and manual BG entry are participant-facing workflow inputs in the current baseline
  • Dexcom remains the source of truth for primary CGM alarming behavior
  • the current package is focused on local device/app behavior, not full device-to-cloud or production auth closure

High-Level Functional Areas In Scope

  • runtime step scheduling and wake-cause handling
  • CGM intake and availability handling
  • DASH pump status, delivery, and alert normalization
  • algorithm execution and guarded command application
  • Home, meal, BG, pump, and CGM operational workflows
  • alert presentation, acknowledgement, and review behavior relevant to study use
  • software-facing IFU and operational screenshot package

Explicit Baseline Boundaries

This packet does not establish closure for:

  • full cloud/device-to-cloud verification
  • Part 11 closure
  • broader authentication/authorization/provider-policy closure
  • broader cybersecurity hardening beyond the documented investigational baseline

Primary Support References