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Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.

Control-IQ+ technology is intended for single patient use and requires a prescription.

The Subject Device, Control-IQ+ technology ("Control-IQ+") is a software-only device intended for the management of type 1 and type 2 diabetes mellitus. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided by the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ+ technology is meant to be installed on a compatible ACE pump.

Control-IQ+ technology has three different modes: Normal, Sleep, and Exercise. The glucose targets are not individually customizable in these modes but can change based on the mode selected. During Normal mode, Control-IQ+ technology aims to control glucose within a target range of 112.5 – 160 mg/dL, during Sleep mode the target range is 112.5 – 120 mg/dL, and during Exercise mode the target range is 140 – 160 mg/dL.

Control-IQ+ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when Control-IQ+ technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.

Control-IQ+ technology requires users to input their weight and their total daily insulin requirement, which should be established with the help of a health care provider before using the device.

This FDA 510(k) clearance letter describes the acceptance criteria and study for the Control-IQ+ technology, an interoperable automated glycemic controller.

It's important to note that this device is a software-only device (Control-IQ+ technology), and the primary change described in this 510(k) is the addition of a new compatible insulin (Lyumjev U-100 Insulin) for use with the existing Control-IQ technology. The clearance relies heavily on the substantial equivalence to a predicate device (K243823, Control-IQ+ technology) and a clinical study demonstrating the safety and effectiveness of the new compatible insulin with the existing Control-IQ system.

Here's the breakdown of the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" for the Control-IQ+ technology's performance in terms of glucose control metrics (e.g., time in range, hypoglycemia rates) for this specific 510(k) submission. Instead, the "acceptance" for this submission appears to be based on demonstrating non-inferiority or better safety when using the new insulin (Lyumjev) with the already cleared Control-IQ system, compared to established benchmarks.

The primary "performance" mentioned is related to safety, specifically the rates of severe hypoglycemia and DKA.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 179 participants with type 1 diabetes.
  • 70 adults (18-75 years old)
  • 109 pediatric participants (6-17 years old)
• Data Provenance: The study was a "single-arm prospective safety trial." While the exact country of origin isn't specified, FDA clearances typically involve studies conducted in the US or under protocols recognized by the FDA. The T1D Exchange clinic registry is a US-based registry, suggesting a likely US context for the study.
• Retrospective/Prospective: Prospective. The study involved an initial (~16-day) Humalog Lead-in Period and a subsequent (13-week) Lyumjev Treatment Period.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of device (automated glycemic controller) does not typically involve expert review for "ground truth" in the same way an imaging or diagnostic AI might. The "ground truth" for glucose control is direct physiological measurements (iCGM readings) and clinical outcomes (hypoglycemia, DKA). Therefore, specific numbers or qualifications of experts for establishing ground truth are not applicable in this context. The study design itself serves to establish the performance and safety against clinical outcomes.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective expert interpretation of data (e.g., radiologists reviewing images). For a system controlling insulin delivery based on CGM data, adjudication of such a type is not applicable. Clinical events (severe hypoglycemia, DKA) are typically adjudicated by an independent clinical endpoint committee or medical monitors based on predefined criteria, but the document does not specify this level of detail.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.
MRMC studies are relevant for diagnostic aids where human readers interpret data (e.g., images) with and without AI assistance to measure improvement in reader performance. Control-IQ+ technology directly controls insulin delivery; it is not an assistive diagnostic tool for human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The device is an "Interoperable Automated Glycemic Controller," meaning it operates to "automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values." It also delivers "correction boluses." This indicates that the core function is standalone (algorithm-only) in its closed-loop operation. While users can input data (carbohydrate intake, exercise, sleep schedule) and the device is intended for "single patient use" with a "prescription," the control logic itself functions automatically without continuous human intervention in real-time decision-making for insulin delivery adjustment. The study evaluates the system performance which includes this automated functionality.

7. The Type of Ground Truth Used

The ground truth used for this study was primarily:

• Physiological data: iCGM readings for glucose values.
• Clinical Outcomes Data: Rates of severe hypoglycemia and DKA events. These were compared against "reported frequencies from the T1D Exchange clinic registry" as a benchmark for safety.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set of the Control-IQ+ technology. This 510(k) is for a modification (new compatible insulin) to an already cleared device, implying the core algorithm was trained and validated previously.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set of the original Control-IQ algorithm was established. Given the nature of an automated glycemic controller, it would typically involve extensive simulations, in-silico testing, and potentially prior clinical trials where continuous glucose monitoring (CGM) data, insulin delivery data, and corresponding blood glucose measurements were collected and used to train and validate the control algorithms. However, this specific 510(k) submission focuses on the safety and effectiveness of a new component (Lyumjev insulin) with the existing system rather than the initial foundational algorithm development.

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