CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes.

Study design (if review, criteria of inclusion for studies)

Single-center, open-label, random-order, crossover trial.


Twenty adults with Cystic fibrosis-related diabetes (CFRD)


Automated insulin delivery with the iLet bionic pancreas (BP). Participants were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity.

Outcome measures

The primary outcome was the percent time sensor-measured glucose was in target range 70-180 mg/dL (time in range [TIR]) on days 3-14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range <54 mg/dL.

Main results

TIR was significantly higher in the BP arm than the UC arm (75 ± 11% vs. 62 ± 22%, P = 0.001). Mean CGM glucose was lower in the BP arm than in the UC arm (150 ± 19 vs. 171 ± 45 mg/dL, P = 0.007). There was no significant difference in percent time with sensor-measured glucose <54 mg/dL (0.27% vs. 0.36%, P = 1.0), although self-reported symptomatic hypoglycemia episodes were higher during the BP arm than the UC arm (0.7 vs. 0.4 median episodes per day, P = 0.01). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either arm.

Authors' conclusions

Adults with CFRD had improved glucose control without an increase in CGM-measured hypoglycemia with the BP compared with their UC, suggesting that this may be an important therapeutic option for this patient population.

Keywords: Diabetes Mellitus; Gastrointestinal Diseases; non pharmacological intervention - devices OR physiotherapy; Pancreatic Diseases; insulin;