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 Indications for Use
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.

Bolus Calculator
Indications for Use
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, carbohydrate ratio, correction range, and current active insulin.

REFERENCES

1. The twiist Automated Insulin Delivery (AID) System Powered by Tidepool User Guide, Sequel Med Tech: DKPI-09233-001 1.3 2024-02-23.
2. Calculation based on the following sources, reporting 1 U/hr basal rate: Omnipod 5 Technical User Guide (PT-001716-AW Rev03 03/24,) MiniMed 780G System User Guide (M036461C001 2). iLet Bionic Pancreas System User Guide (LA000081_D). Calculation based on the following sources, reporting 2 U/hr basal rate: t:slim X2 Insulin Pump User Guide (AW-1011648_B), Tandem Mobi System User Guide (AW-1012691_A 2023-Dec-07.)
3. Omnipod 5 Technical User Guide. Insulet Corporation: PT-001716-AW Rev. 03 03/24.
4. MiniMed 780G with the Guardian. Sensor System User Guide, Medtronic: M036461C001_2 2023-02-24.
5. t:slim X2 Insulin Pump with Control-IQ Technology User Guide, Tandem Diabetes Care: AW-1011648_B 2023-Nov-09.
6. Tandem Mobi System, Tandem Diabetes Care: AW-1012691_A 2023-Dec-07.
7. iLet Bionic Pancreas System Quick Reference Guide, Beta Bionics: LA000082_E.
8. Lum JW, Bailey RJ, Barnes-Lomen V, et al. A real-world prospective study of the safety and effectiveness of the Loop open source automated insulin delivery system. Diabetes Technol Ther. 2021;23(5):367-375.
9. Wong JJ, et al. Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System. J Diabetes Sci Technol 2023;17:1440–7.
10. R. D. Butterfield and N. M. Sims, “Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump with Acoustic Volume and Flow Sensing in Simulated High Consequence Situations,” in IEEE Open Journal of Engineering in Medicine and Biology, doi: 10.1109/OJEMB.2024.3408092.