Name of the Procedure:

Artificial Pancreas Device System (S1034)

Commonly referred to as:

• Artificial Pancreas
• Closed-Loop Insulin Delivery System
• Low Glucose Suspend (LGS) Feature

Summary

An artificial pancreas device system is an advanced medical technology designed to help people with diabetes manage their blood sugar levels. It includes a continuous glucose monitor (CGM), an insulin pump, and a computer algorithm that communicates with both devices to automatically adjust insulin delivery based on real-time glucose readings.

Purpose

Medical Conditions:

• Type 1 Diabetes
• Insulin-dependent Type 2 Diabetes

Goals:

• Maintain optimal blood glucose levels.
• Minimize the risk of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar).
• Improve overall diabetes management and quality of life.

Indications

Symptoms/Conditions:

• Frequent episodes of hypoglycemia.
• Difficulty maintaining stable blood glucose levels.
• Poor HbA1c control despite conventional treatment.

Patient Criteria:

• Diagnosed with insulin-dependent diabetes.
• Previously tried multiple daily insulin injections or standard insulin pump therapy without sufficient control.

Preparation

Pre-Procedure Instructions:

• Keep a log of recent glucose readings.
• Continue usual diabetes medications unless instructed otherwise by a healthcare provider.
• Attend training sessions on how to use the CGM and insulin pump.

Diagnostic Tests/Assessments:

• Comprehensive metabolic panel.
• Glycated hemoglobin (HbA1c) test.
• Assessment of current diabetes management practices.

Procedure Description

1. Continuous Glucose Monitor (CGM): A sensor is inserted under the skin to continuously measure glucose levels in the interstitial fluid.
2. Insulin Pump: A small device worn on the body that delivers insulin through a catheter placed under the skin.
3. Computer Algorithm: Software calculates insulin needs based on CGM data and communicates with the insulin pump to adjust delivery in real-time.
4. Blood Glucose Device: Used initially to calibrate the CGM and for occasional additional glucose checks.

Technology Used:

• CGM sensors.
• Insulin pump.
• Computer algorithm with a control device (smartphone or dedicated monitor).

Anesthesia/Sedation:

• Typically not required.

Duration

• Initial setup and training may take several hours.
• Ongoing use is continuous, with periodic maintenance and calibration.

Setting

• Outpatient diabetes clinic or specialized medical facility.

Personnel

• Endocrinologist or diabetologist.
• Certified diabetes educator.
• Registered nurse specialized in diabetes care.
• Technical support staff for device setup.

Risks and Complications

Common Risks:

• Skin irritation or infection at sensor/pump sites.
• False or inaccurate glucose readings.
• Device malfunction.

Rare Complications:

• Severe hypoglycemia or hyperglycemia if the system fails.
• Allergic reactions to adhesives or materials.

Management:

• Regular monitoring and troubleshooting.
• Education on manual insulin administration in case of device failure.

Benefits

• Improved blood glucose control.
• Reduced frequency and severity of hypoglycemia.
• Enhanced quality of life and ease of diabetes management.
• Benefits can be realized within days to weeks of initiating therapy.

Recovery

Post-Procedure Care:

• Regular device maintenance, such as sensor replacements and pump site changes.
• Continuous monitoring of blood glucose levels.

Recovery Time:

• No downtime required; patients can resume normal activities immediately.
• Periodic follow-up appointments for assessment and device calibration.

Alternatives

Other Treatment Options:

• Multiple daily insulin injections.
• Standard insulin pump without CGM integration.

Pros and Cons:

• Daily Injections: Less costly but more manual management.
• Standard Insulin Pump: Offers continuous delivery but requires manual blood glucose monitoring and adjustments.

Patient Experience

During the Procedure:

• Initial discomfort from sensor and catheter insertions.
• Learning curve for device operation.

After the Procedure:

• Potential skin irritation.
• Continuous monitoring offers peace of mind.
• Adjustments in insulin delivery can improve overall comfort.
• Education on dealing with alarms and troubleshooting is crucial for successful use.

Pain Management and Comfort Measures:

• Local anesthetic creams for site insertions.
• Ongoing support from healthcare providers to address concerns and optimize device settings.