Diabetes technology

A Pilot Outpatient Assessment of a Fully Closed-Loop Insulin and Pramlintide System

J Diabetes Sci TechnolPublished Randomised controlled trial

Authors' conclusion

This study suggests that automated insulin and pramlintide systems have the potential to alleviate carbohydrate counting without degrading time in range. A longer and larger study is underway.

Study context

Population
Adults with T1D (7 females, age 39.5 [15.1], HbA1c 7.4% [0.6]); 14-h outpatient free-living supervised experiments
Participants
12 adults
Comparison
Fully closed-loop insulin + pramlintide without carbohydrate counting vs faster aspart with carbohydrate counting
Methodological detailspilot, five-arm, outpatient, free-living, supervised
  • Pilot
  • Five-arm
  • Outpatient, free-living, supervised

Primary result

As reported in the abstract

Time in target range (3.9-10.0 mmol/L) · 14 hours

Control

78.6

median · IQR 65.3–92.9

Faster aspart + pramlintide 8 µg/U

76.2

median · IQR 64.6–86.9

Faster aspart + pramlintide 10 µg/U

78.8

median · IQR 68.8–86.0

Aspart + pramlintide 8 µg/U

65.9

median · IQR 59.9–83.6

Aspart + pramlintide 10 µg/U

77.4

median · IQR 72.1–82.7

Safety

Time below 3.9 and 3.0 mmol/L

Numerically higher with fully closed-loop aspart + pramlintide systems than control; not statistically significant

Original publication

A Pilot Outpatient Assessment of a Fully Closed-Loop Insulin and Pramlintide System. J Diabetes Sci Technol. Published 14 October 2025. doi:10.1177/19322968251371046

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