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The Insulia Bolus Companion is indicated for the management of diabetes by adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data.

Prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. This can be done through a dedicated, secured web portal.

Insulia Bolus Companion is a prescription device indicated for the management of diabetes, for adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data; and for healthcare professionals (HCP) having experience in the management of people with diabetes treated with bolus insulin.

Insulia Bolus Companion is for prescription use and is not for over-the-counter sale.

Insulia Bolus Companion includes a Bolus Calculator intended to provide direction to the patient in response to blood glucose (BG) and health events, within the scope of a preplanned treatment program prescribed by their HCP for insulin suggestions. The guidance is similar to the directions provided to patients as a part of routine clinical practice: prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software.

An HCP can only start using Insulia Bolus Companion after having been registered by the Manufacturer or the delegate field-support team.

Insulia Bolus Companion includes three components:

• · A mobile application for use by people with diabetes on commercially available smartphones (iPhone or Android) and tablets, enabling patients to document BG measurements, meals, and generate dose suggestions for bolus insulin
• · A web-based application for use by HCPs in professional healthcare settings through a compatible web browser on a computer, allowing patient inclusion and patient monitoring in-person and by distance
• · A secure database hosted in a private cloud environment and used to securely store patient data

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria, specifically regarding numerical performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods.

The document states that "Design verification and validation testing on Insulia Bolus Companion demonstrated that the device meets the performance requirements for its intended use" and "performance testing has demonstrated that Insulia Bolus Companion performs as intended and is substantially equivalent to the predicate device." However, it does not provide the specifics of this performance testing.

Therefore, I cannot provide a detailed answer to your request that includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number of experts and their qualifications used for ground truth.
4. Adjudication method.
5. Effect size for MRMC study (as no mention of such a study is made).
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory submission process, demonstrating substantial equivalence to a predicate device, and outlining the device's indications for use and general technological characteristics.

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