Integrated Insulin Patch Pump with CGM Shows Safe, Reliable Performance: Study
Australia: A clinical feasibility study published in the Journal of Diabetes Science and Technology has found that an integrated insulin patch pump with continuous glucose monitoring demonstrated safe and reliable insulin delivery, with no reported failures or adverse events.
The first-in-human investigation, led by Hannah Cunningham from the University of Melbourne, explored a novel device that combines a patch pump (PP) with a glucose-sensing insulin delivery cannula (CGM-IS). This integrated system is designed to simplify diabetes management by reducing the need for multiple insertions or external tubing, potentially offering a more convenient alternative for individuals living with Type 1 Diabetes.
The study was conducted in two phases involving adults already experienced in insulin pump and continuous glucose monitoring (CGM) use. In the initial pilot phase, three participants underwent a 12-hour mixed meal test to evaluate early device performance. The second phase included 15 participants who used the device for over 72 hours. This phase incorporated structured meal testing on days one and three, along with a supervised free-living day in a controlled hotel setting to ensure participant safety.
The following were the key findings:
- A total of 26 devices were inserted in 18 participants, with a mean age of 51 years, and a majority being female.
- Nine sensor failures occurred immediately after insertion, requiring replacement, but device performance remained stable thereafter.
- No serious adverse events were reported during the study.
- The primary outcome assessed glucose sensor accuracy using mean absolute relative difference (MARD).
- The device demonstrated a MARD of 11.6% compared with reference laboratory measurements.
- Consensus error grid analysis showed over 83% of readings in zone A (highest accuracy).
- All glucose readings fell within clinically acceptable zones A and B.
- The findings indicate reliable glucose monitoring suitable for clinical application.
- Insulin delivery performance remained uncompromised throughout the study.
- Average glucose levels, time in target range, and total daily insulin dose were comparable to baseline.
- Integration of the patch pump and sensor into a single system did not adversely affect insulin administration.
The researchers noted limitations, including variability in insulin dosing and the use of manual boluses instead of standard automated insulin delivery. The controlled setting may limit real-world applicability, though structured meal tests enabled a robust evaluation of sensor accuracy across a wide glucose range.
Overall, the study demonstrates the feasibility of combining insulin delivery and glucose monitoring into a single device. The authors suggest that such systems may be more acceptable to patients compared to traditional pump setups that require separate components. Future research will focus on improving the insertion process, enhancing sensor precision, and incorporating real-time automated insulin delivery features to align with current treatment standards.
Reference:
Cunningham, H., Jones, H., Flint, S., Netzer, E., Dutt-Ballerstadt, R., Eckenberg, P., Obeyesekere, V., Brown, K. E., Sims, C., Reid, S., Wu, H. P., Seidl, T., Both, M., Auderset, A., Eymann, D., Lodico, T., Schoemaker, M., & Kong, Y. W. First in Human Feasibility Study of an Insulin Patch Pump Combined With CGM-Insulin Delivery Cannula. Journal of Diabetes Science and Technology. https://doi.org/10.1177_19322968261436412
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