BionicLoop Instructions for Use (IFU)

Revision History

Table of Contents

Investigational Use Statement

BionicLoop is investigational software and is not approved for independent clinical treatment use.

• Use only under approved study protocol and supervision.
• Use only after protocol-specific training on Dexcom G7, Omnipod DASH, and BionicLoop workflows.
• Do not rely on BionicLoop as the sole basis for treatment decisions outside approved investigational procedures.
• Follow site escalation procedures for therapy-impacting alarms, workflow failures, device faults, and documentation.

1. About This Guide

This IFU describes how trained study users should:

• sign in and recover app access,
• review Home before acting,
• verify clinical settings and start the algorithm session,
• set up CGM and Pod workflows,
• enter manual BG values,
• announce meals,
• stop an in-progress meal-announcement delivery if needed,
• review alerts and recent dose steps,
• document and escalate unresolved issues.

Intended Users

This guide is written for:

• clinicians,
• study staff,
• trained supervised operators.

What This Guide Does Not Replace

This guide does not replace:

• Dexcom G7 app instructions,
• Omnipod DASH setup and safety instructions,
• study protocol,
• site-specific escalation procedures.

2. System Overview

BionicLoop is a research closed-loop app that uses Dexcom G7 glucose data, Omnipod DASH pump connectivity, and a 5-minute algorithm step cadence to present current status and algorithm-directed dosing context.

System Components

What BionicLoop Does

• displays current CGM, Pod, and loop status on Home,
• supports clinical configuration and algorithm session control,
• accepts manual BG entry,
• accepts meal announcement input,
• records recent algorithm/dosing steps for review,
• presents in-app alerts and recent alert history.

What BionicLoop Does Not Do

• BionicLoop does not replace Dexcom G7 app alarming.
• BionicLoop does not send OS notifications for CGM alerts.
• BionicLoop CGM alerts are informational on Home / Alert Center.
• Dexcom G7 app remains the source of truth for CGM alarms and should be configured per protocol.

3. Before First Use

Before supervised use, confirm all of the following.

3.1 Training and Readiness Checklist

1. The user has been trained on the study workflow and escalation rules.
2. The iPhone is charged and Bluetooth is enabled.
3. The user can sign in or site login support is available.
4. Dexcom G7 app access is available for pairing and sensor management.
5. Pod supplies and site procedures are available.
6. Subject ID, weight, and approved clinical settings are available.
7. The user understands that unresolved therapy-impacting issues require escalation, not repeated blind retries.

3.2 Daily Start-of-Shift Checks

Before initiating therapy-impacting actions:

1. Launch BionicLoop and confirm the correct subject context.
2. Confirm CGM value freshness and trend availability.
3. Confirm Pod presence and connection state.
4. Review active alerts before announcing a meal or entering BG.
5. If using remote monitoring, confirm login/session continuity.

4. Sign In and Account Access

Use the authentication flow when the app opens to login-required state.

1. Launch the app.
2. Enter the required account identifier.
3. Select Secure Sign In.
4. Use Create account or Forgot password? only when authorized for the current workflow.
5. If authentication cannot be completed, stop and escalate per site process.

4.1 If Login Is Lost During Active Therapy

If the app indicates login is required while therapy remains active:

• treat this as a monitoring/session continuity issue,
• reauthenticate as soon as permitted,
• continue to follow protocol-defined local safety procedures,
• document any remote-monitoring gap.

5. Home Screen Orientation

Home is the operational landing surface and should be reviewed before any action.

5.1 What to Review on Home

5.2 If Home Does Not Look Ready

Do not proceed directly to meal announcement or therapy-impacting action if:

• CGM is missing or stale,
• Pod is not available,
• a pump fault/incompatible/expired condition is active,
• an interruption or blocked-state alert is active and unresolved.

6. Settings, Clinical Configuration, and Dose Review

Use Settings to review the user/session state, device entry points, recent dose history, and protected clinical settings.

6.1 Open Settings

1. Tap the settings gear on Home.
2. Review the current target, subject ID, weight, and algorithm-input summary.
3. Open device settings from this sheet when CGM or Pod setup/review is needed.

6.2 Review Recent Dose Steps

Use Recent Dose Steps when you need to confirm what the algorithm recently recommended and delivered.

1. Open Settings.
2. Tap Recent Dose Steps.
3. Review step number, delivered dose, CGM value, and timestamps.
4. Use this screen when documenting workflow review or reconciling recent activity.

6.3 Clinical Settings

Clinical Settings are passcode-protected and should only be changed by authorized users.

1. Open Settings.
2. Open Clinical Settings.
3. Unlock using the approved passcode.
4. Review or update:
   • Subject ID
   • Weight (lb)
   • target profile / glucose target
   • meal split
   • TMAX
5. Save only after confirming the values match the approved subject plan.

6.4 Start Algorithm Session

Use Start Algo only from Clinical Settings, and only when no active algorithm session is already running.

Before starting:

1. Confirm subject ID and weight.
2. Confirm the approved target profile and input settings.
3. Confirm CGM and Pod workflows are ready enough to support the first anchored loop step.

7. Dexcom G7 Workflow

Use the CGM flow to onboard or review Dexcom G7 status inside BionicLoop.

7.1 First-Time CGM Setup

1. Open Settings.
2. Select Open CGM Settings.
3. Follow the guided Dexcom G7 setup path.
4. Continue pairing/calibration/sensor-management tasks in the Dexcom app as required.

7.2 Review CGM Status

Use the CGM settings view to confirm sensor details and recent reading status.

Check:

• sensor expiration timing,
• last reading value and timestamp,
• trend information,
• Bluetooth freshness/connection recency.

7.3 CGM Alarm Handling

If a low, urgent low, high, or other sensor alarm is clinically relevant:

1. Use the Dexcom app as the primary alarm source.
2. Respond per protocol.
3. Use BionicLoop only as supplemental review context on Home / Alert Center.

8. Pod Workflow

Use the Pod flow to begin DASH onboarding or to return to pump-related setup when a new Pod is needed.

1. Open Settings.
2. Select Open Pod Settings.
3. Follow the Pod setup instructions for reminder configuration, fill, pairing, and placement.
4. Complete all physical device steps per Omnipod instructions.

8.1 Before Proceeding With Pod-Dependent Actions

Confirm:

• the Pod is active,
• signal is present,
• no pump fault/incompatible/setup-incomplete alert is active,
• the Pod is not beyond its usable service window.

9. Routine Daily Workflows

9.1 Manual BG Entry

Use manual BG only when needed per protocol or when prompted by the workflow.

1. On Home, tap the droplet button.
2. Select the BG value.
3. Confirm the entry using Use BG.
4. Cancel if the value is not ready to submit.

9.2 Meal Announcement

Use meal announcement only when Home is ready and the workflow is available.

1. On Home, tap Let's Eat.
2. Select meal type.
3. Select the relative carb content for that meal.
4. Review the enabled delivery control.
5. Slide to deliver when the meal announcement is correct.

9.3 Cancel In-Progress Meal Delivery

If meal-announcement delivery is already in progress, Home presents a dedicated red Cancel Delivery slider beneath the main action row.

1. Verify that the cancel action is for the active meal-announcement delivery.
2. Slide Cancel Delivery.
3. Wait for the Home summary to report what insulin was actually delivered.
4. If another meal announcement is still needed, reopen the meal flow and re-enter it deliberately.

9.4 How to Interpret the Partial Delivery Summary

If the Home banner states that a partial amount was delivered:

• the algorithm requested more insulin than was actually delivered,
• the displayed delivered amount is the amount that reached the pump before cancellation,
• the partial-delivery summary remains visible long enough for review and then clears automatically after a later step and minimum display time,
• the delivered amount remains part of the recorded therapy history.

9.5 Alert Review

Use Alert Center to review active alerts and recently cleared alerts.

1. Tap the bell on Home.
2. Review all active alerts before proceeding with therapy-impacting actions.
3. Acknowledge or resolve alerts only as permitted by workflow and protocol.
4. Use the recent section to confirm a condition has cleared.

10. Alerts and User Response

Alert handling should be based on the alert source and the risk to ongoing therapy.

10.1 Pump / Therapy-Impacting Alerts

Examples include:

• pump fault,
• incompatible Pod,
• no active Pod,
• signal loss,
• Pod expired / stopping dosing soon,
• setup incomplete,
• algorithm stepping interrupted when delivery cannot proceed normally.

User action:

1. Read the alert fully.
2. Resolve the underlying device or workflow issue.
3. Do not assume therapy is normal until the Home state and alerts agree that the condition is cleared.

10.2 CGM Alerts Inside BionicLoop

CGM alerts in BionicLoop are informational app context only.

• BionicLoop does not send OS notifications for CGM alerts.
• Dexcom app remains the source of truth for urgent low and other CGM alarm behavior.
• A BionicLoop urgent-low review alert may appear in-app for trustworthy glucose below the urgent-low threshold; this is a review aid and does not replace Dexcom alarming.

10.3 Alert-Response Principles

Use the following response sequence:

1. Check whether the alert changes therapy readiness.
2. Confirm the device state directly when applicable.
3. Review Home and recent dose context.
4. Escalate unresolved therapy-impacting conditions instead of repeatedly retrying actions.

11. Troubleshooting and Recovery

11.1 If the Screen State and Device State Do Not Match

If BionicLoop and the physical device/app state do not appear to agree:

1. Stop and reassess.
2. Review active alerts.
3. Verify Dexcom state in the Dexcom app and Pod state in the Pod workflow.
4. Capture screenshots if needed.
5. Escalate per site process.

12. Documentation and Escalation

For unresolved or therapy-impacting conditions:

1. Stabilize the situation per study protocol.
2. Record the time and sequence of events.
3. Capture the relevant Home / Alert Center / device screen.
4. Note any partial delivery amount or relevant recent step context.
5. Escalate to the supervising clinical/study contact.

Appendix A. Figure Index

Appendix B. Abbreviations and Acronyms

Appendix C. Daily Use Quick Checklist

1. Confirm the correct subject and active session context.
2. Confirm CGM freshness.
3. Confirm Pod readiness.
4. Review alerts before acting.
5. Use Manual BG or Let's Eat only when Home is ready.
6. Review any partial delivery or interruption summary before proceeding.
7. Document and escalate any therapy-impacting mismatch or unresolved alert.