NCT04361799

Perioperative Closed-loop Glucose Control

Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management.

Conditions

• Perioperative Hyperglycaemia
• Insulin Therapy
• Elective Surgery
• Closed-Loop Glucose Control
• Artificial Pancreas

Interventions

Type	Name	Description
DEVICE	CamAPS	Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
DRUG	Standard insulin therapy	Standard insulin therapy according to local clinical practice.

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2020-04-24
• Last updated: 2021-12-17

Locations

1 site across 1 country: Switzerland