Bionic Pancreas Research
Trial question
What is the role of bionic pancreas in patients with T1DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 326
326 patients (148 female, 178 male).
Inclusion criteria: patients ≥ 6 years of age with T1DM.
Key exclusion criteria: plan to change usual diabetes regimen in 3 months; hemoglobinopathy; history of cystic fibrosisl; pancreatitis; or other pancreatic diseases.
Interventions
N=219 bionic pancreas (automated delivery of insulin aspart or insulin lispro for 13 weeks).
N=107 standard care (any insulin-delivery method plus continuous glucose monitoring).
Primary outcome
Glycated hemoglobin level at week 13
7.3%
7.7%
7.7 %
5.8 %
3.9 %
1.9 %
0.0 %
Bionic
pancreas
Standard
care
Significant
decrease ▼
NNT = 249
Significant decrease in glycated hemoglobin level at week 13 (7.3% vs. 7.7%; ARD -0.5, 95% CI -0.6 to -0.3).
Secondary outcomes
No significant difference in time with glucose level < 54 mg/dL at week 13 (0.3% vs. 0.2%).
Significant decrease in glucose level at week 13 (164 mg/dL vs. 181 mg/dL; AD -16 mg/dL, 95% CI -19 to -12).
Significant increase in time with glucose level 70-180 mg/dL at week 13 (65% vs. 54%; AD 11%, 95% CI 9 to 13).
Safety outcomes
No significant difference in severe hypoglycemia.
Conclusion
In patients ≥ 6 years of age with T1DM, bionic pancreas were superior to standard care with respect to glycated hemoglobin level at week 13.
Reference
Bionic Pancreas Research Group, Steven J Russell, Roy W Beck et al. Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. N Engl J Med. 2022 Sep 29;387(13):1161-1172.
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