HCP Pivotal Trial Results

Now you can have your patients GO BIONIC

The Bionic Pancreas Pivotal Trial is the largest randomized controlled trial evaluating the safety and efficacy of an AID system1

Primary outcome

• HbA1c at 13 weeks vs Standard of Care

Key secondary outcome

• Time CGM glucose < 54 mg/dl over 13 weeks vs Standard of Care

Other secondary end points

• Mean CGM

• Time in Range

Number of patients included in trial – 440

• iLet Bionic Pancreas (Humalog/Novolog and Fiasp) – 333

• Standard of Care – 107


White (Non-Hispanic)




Black (Non-Hispanic)


Other or more than one race

Diabetes doesn’t discriminate

Our pivotal study participant population was more diverse and representative of the US T1D community than any other pivotal trial of an AID system2-7

Nearly 2/3 had a baseline
HbA1c >7.5%

Insulin Delivery

• Insulin delivery: ≥33% MDI

• Insulin pump without automation: 31%

• Insulin pump with automation: 35%

• Control IQ (23%)

• 670G (8%)

• Predictive Low Glucose Suspend Devices (4%)

No Exclusions for

• Hypoglycemic unawareness

• Recent episodes of severe hypoglycemia

• Recent episodes of DKA

• Recent hospitalization for dysglycemia

• Baseline HbA1c

1. Brown, S. A. et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care 44, dc210172 (2021). 2. Breton, M. D. et al. A Randomized Trial of Closed- Loop Control in Children with Type 1 Diabetes. New Engl J Med 383, 836–845 (2020). 3. Brown, S. A. et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. New Engl J Med 381, 1707–1717 (2019). 4. https://www.accessdata.fda.gov/cdrh_docs/ pdf16/p160017b.pdf. 5. Russell, S.J., et al. (2022) A Multicenter Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. The New England Journal of Medicine. 387:1161–1172.. 6. Lawrence, J. M. et al. Trends in Prevalence of Type 1 and Type 2 Diabetes in Children and Adolescents in the US, 2001-2017. JAMA 326, 717–727 (2021).

The iLet Bionic Pancreas improved HbA1c more in those with a baseline HbA1c of >7%

The study was not designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by baseline HbA1c. Individual user results may vary from the average values shown here.

1. Kruger, D,. et. Al. (2022) A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes. Diabetes Technology and Therapeutics 2022; 24:697–711. 2. Messer, L.H., et al.(2022) Positive impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial. Diabetes Technology and Therapeutics 2022; 24:712–725.

By using the iLet Bionic Pancreas, your patients, on average, can have nearly 1,000 more hours Time in Range each year 1

Ready to GO BIONIC?

The iLet Bionic Pancreas automatically adjusts to your insulin needs so you don’t have to.