About This Calculator

This content provides clinical context for the Tresiba® Dose Calculator. The tool is designed for healthcare professionals to determine appropriate starting doses and titration strategies for Tresiba® (insulin degludec) in adult and pediatric patients (1 year of age and older) with Type 1 or Type 2 diabetes. It accounts for whether a patient is new to insulin (insulin-naïve) or is switching from another insulin regimen.

Calculator Outputs

Upon entering the required patient data, the calculator provides the following outputs:

• Recommended Starting Dose: A precise starting dose in units for once-daily administration.
• Titration Guidance: General recommendations for adjusting the dose based on fasting plasma glucose levels to achieve glycemic targets.
• Clinical Rationale: A brief explanation of the basis for the calculated dose, such as a 1:1 conversion, a weight-based calculation, or a standard fixed start.
• Safety Notes: Important considerations, including warnings for dose reductions when switching from certain insulins to mitigate the risk of hypoglycemia.

How to Use the Calculator

Follow these steps to obtain a dosing recommendation:

1. Select Patient Profile: Choose between 'Type 1 Diabetes' and 'Type 2 Diabetes'.
2. Define Insulin History: Indicate if the patient is 'Insulin-Naïve' or 'Switching Insulin'.
3. Enter Patient Details: Input the patient's age and select the Tresiba® product concentration (U-100 or U-200).
4. Provide Dosing History (if switching): If the patient is switching, select their previous insulin regimen and enter the total daily dose. For twice-daily regimens, provide morning and evening doses separately.
5. Provide Weight (if T1DM Naïve): If the patient has Type 1 Diabetes and is insulin-naïve, enter their weight in kilograms (kg) or pounds (lbs).
6. Calculate: Click the "Calculate" button to view the results.

Dosing Overview

The calculator's logic is based on official prescribing information and clinical guidelines:

• Type 2 Diabetes (Insulin-Naïve): The recommended starting dose is a fixed 10 units administered once daily.
• Type 1 Diabetes (Insulin-Naïve): The starting dose is weight-based. The total daily insulin (TDD) is estimated at 0.2 to 0.4 units/kg, with the basal dose (Tresiba®) comprising approximately one-third to one-half of this TDD. The remainder must be given as prandial (mealtime) insulin.
• Dose Titration: After initiation, the dose should be adjusted to meet individual glycemic targets. A typical approach is to adjust the dose once or twice weekly by ±2-4 units based on self-monitored fasting plasma glucose levels.

Switching to Tresiba®

When converting a patient to Tresiba® from another insulin product, the following conversion rules are applied to minimize the risk of hypoglycemia:

• From other once-daily basal insulins (e.g., insulin glargine U-100, insulin detemir): The conversion is done on a unit-to-unit (1:1) basis.
• From Toujeo® (insulin glargine U-300): A 20% dose reduction from the total daily Toujeo® dose is recommended as the starting dose for Tresiba®.
• From twice-daily NPH insulin or pre-mixed insulin: A 20% dose reduction from the total daily dose of the previous insulin is recommended as the starting Tresiba® dose.

Missed Dose Protocol

Due to its long duration of action, Tresiba® offers flexibility in administration time. If a patient misses a dose, they should take it as soon as they remember. It is crucial to ensure there are at least 8 hours between consecutive injections. Patients should then resume their usual dosing schedule. They should not take an extra dose to make up for the missed one.

Safety Alerts

• Hypoglycemia: The most common adverse reaction associated with all insulin products, including Tresiba®, is hypoglycemia. Patients should be educated on its signs, symptoms, and management.
• Dosing Errors: Differentiate between Tresiba® U-100 (100 units/mL) and U-200 (200 units/mL) to prevent accidental overdose or underdose. The dose window on the FlexTouch® pen shows the number of units to be injected, regardless of concentration.
• Diabetic Ketoacidosis (DKA): Tresiba® is a long-acting basal insulin and must not be used for the treatment of DKA.
• Fluid Retention: Thiazolidinediones (TZDs) taken in combination with insulin may cause dose-related fluid retention and heart failure. Monitor patients for signs of heart failure if this combination is used.

Frequently Asked Questions

Why is the starting dose for insulin-naïve Type 2 patients a fixed 10 units?

A starting dose of 10 units is the recommendation from the prescribing information for insulin-naïve adults with Type 2 Diabetes. It provides a conservative and safe starting point, which is then titrated based on the patient's glucose response.

How does the calculator determine the starting dose for a Type 1 insulin-naïve patient?

It uses a standard weight-based formula, calculating a total daily insulin need of 0.2-0.4 units/kg. The initial basal (Tresiba®) dose is set to 30-50% of this total, with the remainder needing to be covered by prandial insulin.

Why is a 20% dose reduction recommended when switching from Toujeo® or NPH?

This precautionary reduction is advised to lower the risk of hypoglycemia. Toujeo® is a concentrated long-acting insulin, and NPH has a different pharmacokinetic profile. A conservative starting dose for Tresiba® allows for safe titration up to the target glucose level.

Can I use this calculator for a child younger than 1 year?

No. The safety and effectiveness of Tresiba® have been established in pediatric patients aged 1 year and older. The calculator is restricted to this approved age range.

Does the calculator recommend a mealtime (bolus) insulin dose?

No. This tool calculates only the basal (background) insulin dose. Patients with Type 1 Diabetes, and many with Type 2, will also require prandial (mealtime) insulin, which must be prescribed and adjusted separately by the healthcare provider.

What is the clinical difference between Tresiba® U-100 and U-200?

Both contain the same insulin degludec, but U-200 is twice as concentrated. This allows for a smaller injection volume to deliver the same number of units, which can be beneficial for patients requiring larger doses. The FlexTouch® pen accounts for the concentration, so the dose dialed is the dose delivered for both products.

Is it okay to switch the time of day for my Tresiba® injection?

Yes, Tresiba® allows for flexibility in the timing of the once-daily injection. While a consistent schedule is ideal, the injection time can be changed as long as there is a minimum of 8 hours between doses.

References

1. U.S. Food and Drug Administration. (2023). TRESIBA® (insulin degludec) injection Prescribing Information. Silver Spring, MD: FDA. Retrieved from Drugs@FDA.
2. Novo Nordisk Inc. (2024). Tresiba® (insulin degludec) injection 100 U/mL, 200 U/mL - Official Site for Healthcare Professionals. Plainsboro, NJ: Novo Nordisk. Retrieved from tresibapro.com.
3. European Medicines Agency. (2023). Tresiba (insulin degludec) Summary of Product Characteristics (SmPC). Amsterdam, NL: EMA. Retrieved from EMA Official Documents.
4. ElSayed, N. A., Aleppo, G., Aroda, V. R., et al. (2023). 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2023. Diabetes Care, 46(Supplement_1), S140–S157. Retrieved from Diabetes Care.