DTx Product Case Study

Insulia®

An aid in the management of diabetes.

Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

Product Overview

Medical condition:

Targets type 2 diabetes that is treated with long-acting insulin analogs.

Target patient population:

Adult patients with type 2 diabetes being treated with long-acting insulin analogs to manage their diabetes.

What to expect:

Recommends personalized insulin doses and coaches patients to better manage their diabetes.

Clinical Overview

Indications for use:

Insulia® is a prescription-only software medical device intended for use by healthcare professionals and their type 2 adult diabetes patients treated with long-acting insulin analogs as an aid in the management of diabetes.

Outcomes:

In the Telediab 2 randomized trial in France using a predecessor device to Insulia® called “Diabeo-Basal” with patients naïve to basal insulin (baseline A1C 8.9±1.1% ) there was a statistically significant difference in A1C between the control group and Diabeo-Basal groups at 4 months (7.96±0.88% and 7.47±0.9% respectively, p=0.0017). Twice as many patients in the Diabeo-Basal group achieved A1C <7% vs. control (Diabeo-Basal 29.8% vs 12.5%). This study showed that interventions using automated insulin titration software improved glucose control as compared with standard care. Diabeo-Basal is not approved nor cleared for use in the US.

Disclaimer: These clinical outcomes have not been reviewed by the FDA and therefore are not considered as claims on the efficacy of Insulia® in the United States. These outcomes are not indicative of what could happen with Insulia®.

Directions:

Healthcare practitioners prescribe the app by creating a treatment plan tailored to the person’s needs, which generates an activation code. When the person downloads the app and enters their code, Insulia® is already set up to follow their personalized dosing plan. They just add their fasting blood glucose values and Insulia® will recommend basal insulin doses every day. Whether people take their insulin in the morning or evening, experience hypo symptoms, or switch insulins, Insulia® adapts to its users so that they have accurate and reliable dose recommendations at their fingertips.

Since Insulia® connects to a corresponding web portal, healthcare practitioners are able to follow their patients’ progress in real-time and help them when needed. Coaching messages and support ensure that people are never alone as they work to get to the right dose.

Risks & warnings:

Insulia® should not be used for basal dose recommendations with intermediate-acting insulin (NPH – Neutral Protamine Hagedorn) nor with premixed insulin. Insulia® is not intended for use by pregnant women, non-adult patients, or patients that are treated with a basal-plus or a basal-bolus regimen (i.e. including multiple mealtime insulin injections per day or insulin pump therapy).

Place in therapy:

Complementary to basal insulin therapy.

Product Access

Product description:

Insulia® is a software medical device that supports insulin titration for people using any brand of basal insulin including Lantus®, Levemir®, Toujeo®, Tresiba® (U-100), and Basaglar®. It may be used on a compatible smartphone or computer.

Prescription status:

A prescription is required from a qualified healthcare provider.

Patient access:

Patients download Insulia® through their smartphone on the Apple or Google App Store. They can also access a web portal if they do not have a smartphone. An enrollment code is generated for patients after their healthcare provider completes a prescription.

Use of this product requires access to:

Provider access:

Healthcare providers may access the Insulia® dashboard to prescribe Insulia® to their patients, as well as monitor for real-time health trends, potential issues, and view patient-generated health data. Patients are automatically triaged so that those who need attention are seen first. These dashboards are accessible through the Insulia® clinician web portal and through tailored notifications.

Coverage options:

Insulia® is typically paid for by insurance plans. A Savings Program may be available.

Product availability:

Insulia® is available in:

A Day in Life with Insulia®

Insulia® was the first prescription-only digital therapeutic to receive FDA clearance for basal insulin titration.

Clinical Trials

Features: Randomized controlled study with two arms: – Control, naive to basal insulin, just given insulin – Treated with Diabeo (digital therapeutic) + basal insulin

Outcomes: In the Telediab 2 randomized trial in France using a predecessor device to Insulia called “Diabeo-Basal” with patients naïve to basal insulin (baseline A1C 8.9±1.1% ) there was a statistically significant difference in A1C between the control group and Diabeo-Basal groups at 4 months (7.96±0.88% and 7.47±0.9% respectively, p=0.0017). Twice as many patients in the Diabeo-Basal group achieved A1C <7% vs. control (Diabeo-Basal 29.8% vs 12.5%). This study showed that interventions using automated insulin titration software improved glucose control as compared with standard care. Diabeo-Basal is not approved nor cleared for use in the US.

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