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Indications for Use

The twiist system is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages six and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The twiist system is intended for single-patient home use and requires a prescription.

Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the twiist alternate controller enabled (ACE) insulin infusion pump to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user’s confirmation, deliver correction boluses when glucose values are predicted to exceed user configurable thresholds. Loop is intended for the management of type 1 diabetes mellitus in persons six years of age and greater, and is intended for single-patient use. The twiist automated insulin delivery system is for prescription use only.

The simple bolus calculator, available when Loop is off, is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator-entered blood glucose, insulin sensitivity, insulin to carbohydrate ratio, correction range, and current active insulin.


The twiist AID system with the Tidepool Loop is not intended for anyone unable or unwilling to:

  • Test blood glucose (BG) levels as recommended by their
    healthcare provider
  • Maintain sufficient diabetes self-care skills
  • See their healthcare provider regularly
  • Demonstrate adequate carbohydrate-counting skills

The user must not:

  • Have difficulty seeing
  • Have difficulty hearing
  • Have deficient cognitive capabilities
  • Have physical impairments that would make
    operating the device or iPhone difficult

“twiist” and the twiist logo are trademarks of Sequel Med Tech, LLC. “Tidepool” and the Tidepool logo are trademarks of Tidepool Project, a fully-qualified 501(c)(3) nonprofit organization.

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