What are the guidelines for prescribing Continuous Subcutaneous Insulin Infusion (CSII) devices, also known as insulin pumps?

From the Guidelines

Insulin pumps should be prescribed for patients with type 1 diabetes who would benefit from continuous insulin delivery, as they have been shown to have modest advantages for lowering A1C and reducing severe hypoglycemia rates compared to multiple daily injections 1. When considering the prescription of insulin pumps, it is essential to evaluate the patient's diabetes management needs, glycemic control, and ability to manage technology. The prescription should specify the exact pump model, insulin type, and initial settings, including basal rates, insulin-to-carbohydrate ratios, and correction factors. These settings must be individualized based on the patient's current insulin requirements, weight, activity level, and meal patterns.

• The patient's total daily insulin requirements can be estimated based on weight, with typical doses ranging from 0.4 to 1.0 units/kg/day 1.
• The American Diabetes Association/JDRF Type 1 Diabetes Sourcebook notes 0.5 units/kg/day as a typical starting dose in individuals with type 1 diabetes who are metabolically stable, with half administered as prandial insulin and the other half as basal insulin 1.
• Prior to initiating pump therapy, ensure the patient receives comprehensive education on pump operation, site rotation, troubleshooting, and sick day management.
• Regular follow-up appointments should be scheduled at 1-2 weeks after initiation, then every 3 months to adjust settings. The use of automated insulin delivery (AID) systems, also known as hybrid closed-loop systems, has been shown to be safe and effective for people with type 1 diabetes, and may be considered for individuals who are capable of using the device safely 2.
• AID systems have been demonstrated to improve achievement of glycemic goals while reducing the risk of hypoglycemia, and are preferred for individuals with type 1 diabetes who can use them safely 2.
• When choosing among insulin delivery systems, individual preferences, cost, insulin type, dosing plan, and self-management capabilities should be considered 1, 2.

From the FDA Drug Label

2.3 Continuous Subcutaneous Infusion (Insulin Pump) 5.7 Subcutaneous Insulin Infusion Pumps 14.4 Type 1 Diabetes – Adults Continuous Subcutaneous Insulin Infusion 14.5 Type 1 Diabetes – Pediatric Continuous Subcutaneous Insulin Infusion 17.2 For Patients Using Continuous Subcutaneous Insulin Pumps

The guidelines for prescribing Continuous Subcutaneous Insulin Infusion (CSII) devices, also known as insulin pumps, are as follows:

• Dosage considerations should be taken into account when using CSII devices, as outlined in section 2.1 of the drug label.
• The drug label provides information on subcutaneous administration and continuous subcutaneous infusion in sections 2.2 and 2.3, respectively.
• Specific patient populations, such as adults and pediatrics with type 1 diabetes, are discussed in sections 14.4 and 14.5, respectively.
• Patient counseling is essential for patients using CSII devices, as outlined in section 17.2 of the drug label 3. Key points to consider when prescribing CSII devices include:
• Dose adjustment and monitoring to prevent hypoglycemia and other adverse reactions
• Proper use and handling of the insulin pump to ensure safe and effective use
• Regular follow-up with patients to monitor their condition and adjust treatment as needed

From the Research

Guidelines for Prescribing Continuous Subcutaneous Insulin Infusion (CSII) Devices

The guidelines for prescribing CSII devices, also known as insulin pumps, are based on several studies that have evaluated the effectiveness of this treatment in patients with type 1 and type 2 diabetes. The following are some of the key guidelines:

• Patients with type 1 diabetes who have persistent elevated HbA(1c) despite multiple daily injections (MDI), and repeated hypoglycaemia and high glycaemic variability, are likely to benefit from CSII therapy 4.
• Patients with type 2 diabetes who have failed to achieve HbA(1c) targets with MDI may also benefit from CSII therapy 4.
• The total daily dose (TDD) of insulin for patients with type 1 diabetes using CSII should be individualized, with basal insulin representing approximately 30-40% of the TDD 5, 6.
• The carbohydrate-to-insulin ratio (CIR) and correction factor (CF) should be adjusted based on the patient's individual needs and glucose monitoring data 5.
• Patients with central obesity may require higher TDD and TDD per kilogram (TDD kg-1) than those without central obesity 7.
• The ratio of basal to bolus insulin distribution should be individualized, with a mean ratio of 40%:60% reported in one study 7.
• Regular medical supervision and patient education are essential to ensure optimal use of CSII therapy 8, 4.

Patient Selection and Education

The selection of patients for CSII therapy should be based on individualized assessment of their needs and motivations. Patients should be strongly motivated to improve their glucose control and willing to adhere to the treatment regimen. Education on pump treatment should be provided initially and throughout the follow-up period by experienced medical and paramedical teams 8, 4.

Contraindications and Precautions

Absolute contraindications to CSII therapy are rare, but may include severe psychiatric disorders, rapidly progressing ischaemic or proliferative retinopathy, and exposure to high magnetic fields 4. Relative contraindications may include patient non-compliance or inability to cope with the treatment, and should be evaluated individually to assess the benefit/risk ratio 4.