Insulin delivery by implanted pumps: one-year trial with programmable infusion systems (the Point Study).

Area of Science:

• Biomedical Engineering
• Endocrinology
• Diabetes Technology

Background:

• Type I diabetes requires continuous insulin management.
• Implantable insulin pumps offer potential for improved glycemic control.
• Stabilized insulin formulations are crucial for device compatibility.

Purpose of the Study:

• To evaluate the feasibility, safety, and efficacy of a stabilized insulin preparation (HOE 21GH) in remote-controlled implanted infusion pumps.
• To assess glycemic control and complication rates in type I diabetic patients using this system.

Main Methods:

• A feasibility trial involving twenty type I diabetic patients with implanted intraperitoneal or intravenous insulin pumps.
• Collection of 36,077 self-monitored blood glucose measurements over 18.2 patient years.
• Monitoring of symptomatic hypoglycemia, HbA1c levels, and device-related complications.

Main Results:

• 62.9% of blood glucose measurements fell within the target range (70-160 mg/dl).
• Symptomatic hypoglycemia occurred infrequently (2.6 per patient-month), with 0.22 per patient-year requiring medical attention.
• Median HbA1c levels were within or slightly above the upper normal range; three pumps required explantation due to surgical/technical issues.

Conclusions:

• Implanted, remote-controlled insulin delivery devices with stabilized insulin are clinically feasible.
• The system demonstrates potential for effective glycemic management in type I diabetes.
• Ongoing technical and clinical challenges require further investigation and optimization.