(322 days)
The BlueStar® CGM insulin dose calculator is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The BlueStar CGM insulin dose calculator allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and, optionally, insulin on board (IOB). The BlueStar CGM insulin dose calculator requires a prescription.
The BlueStar® CGM insulin dose calculator is a software device module existing in the same mobile medical application as BlueStar® Rx (K203434), which is intended for the management of diabetes. When connected to a compatible integrated continuous glucose monitor (iCGM) and under authorization from a qualified healthcare provider, the BlueStar CGM insulin dose calculator allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent iCGM glucose reading and its rate of change, activity, and, optionally, insulin on board (IOB). Other patient-specific inputs from BlueStar Rx are used in the calculation of the recommended dose- specifically, duration of insulin to carb ratio, correction factor, and target glucose. In addition to calculating specific dosing recommendations, the BlueStar CGM insulin dose calculator also provides coaching messages to assist the user in maintaining glucose within the target range.
The use of CGM inputs differentiates the BlueStar CGM insulin dose calculator from the insulin dose calculator included in the previously cleared BlueStar Rx, which uses blood glucose (BG) values from a BG meter using a "fingerstick" method. The CGM insulin dose calculator is intended to coexist with the BG insulin calculator function in the BlueStar Rx software application as the BG calculation may be necessary when CGM is unavailable or the CGM estimated blood glucose does not match how the user feels.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the primary clinical endpoint serves as the de facto acceptance criterion for efficacy, while safety measures address other key concerns.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Efficacy: Mean CGM Time in Range (TIR) when using the BlueStar® CGM insulin dose calculator is not inferior to baseline TIR (percentage of time spent between 70 and 180 mg/dL). | The statistical analysis of the study data showed that the mean TIR when using BlueStar® with the CGM insulin dose calculator is not inferior to the baseline mean TIR prior to using the device. |
| Safety: No increase in time spent in hypoglycemia (glucose below 70 mg/dL). | There was no increase in time spent with glucose below 70 mg/dL. |
| Safety: No increase in time spent in severe hypoglycemia (glucose below 54 mg/dL). | There was no increase in time spent with glucose below 54 mg/dL in the subject populations. |
| Safety: Acceptable adverse events profile, including hypoglycemic events. | Adverse events including hypoglycemic events were recorded. (The document states they were recorded, and the conclusion mentions "These data support the safety of the Bluestar CGM insulin dose calculator," implying an acceptable safety profile, though specific numbers are not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 27 adult subjects.
- Data Provenance: The document does not specify the country of origin of the data. The study was prospective as data was "collected for each subject for 30 days while using the BlueStar mobile app with the CGM insulin dose calculator."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for the test set. The ground truth was established by the CGM data itself, as it measured glucose time in range.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. The study focused on the effectiveness of the device (BlueStar® CGM insulin dose calculator) in improving or maintaining Time in Range compared to baseline, rather than comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical study assessed the performance of the "BlueStar mobile app with the CGM insulin dose calculator" as used by the subjects. While patients are "human-in-the-loop" by entering carbohydrates, accepting recommendations, and performing activities, the primary performance metric (TIR) evaluates the algorithm's impact on glucose management, implying a standalone assessment of its functional impact when integrated into patient self-management. The device itself is software that calculates a dose, so the clinical study assesses the impact of these calculations on patient outcomes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was outcomes data, specifically CGM glucose time in range (TIR) and time spent in hypoglycemia, measured directly from Continuous Glucose Monitoring (CGM) devices.
8. The sample size for the training set
The document does not provide information about a separate training set or its sample size. The clinical study described appears to be a validation study.
9. How the ground truth for the training set was established
Since information about a training set is not provided, how its ground truth was established is also not available in this document.
§ 862.1358 Insulin therapy adjustment device.
(a)
Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;
(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
(2) The device must not be intended for use in implementing automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;
(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and
(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).