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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.

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.

Control-IQ+ technology (Control-IQ+, the device) 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, this range is changed to 112.5-120 mg/dL. and it is changed to 140-160 mg/dL during exercise mode. 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.

SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

SmartAdjust™ technology is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump. SmartAdjust™ technology is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator are functionally independent from SmartAdjust™ technology. SmartAdjust™ technology is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator. The SmartAdjust™ technology software is installed on both the Omnipod 5 Pod and Omnipod 5 Controller (which contains the Omnipod 5 App), the 2 physical components that make up the Omnipod 5 System. The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; SmartAdjust™ technology disabled) or closed loop (Automated Mode; SmartAdjust™ technology enabled). When Automated Mode is turned on, the SmartAdjust™ algorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

SmartAdjust™ technology is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump. SmartAdjust™ technology is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator functions are functionally independent from SmartAdjust™ technology. SmartAdjust™ technology is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator. The SmartAdjust™ technology software is installed on both the OP5 Pod and OP5 Controller (which contains the OP5 App), the 2 physical components that make up the Omnipod 5 System. The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; SmartAdjust™ technology disabled) or closed loop (Automated Mode; SmartAdjust™ technology enabled). When Automated Mode is turned on, the SmartAdjust™ alqorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Additional age and other restrictions may apply depending on the chosen continuous glucose monitor and insulin pump. CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. The list of supported insulin pumps and CGMs is provided in the User Manual. CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that the linked continuous glucose monitoring system is suitable for use in pregnancy. CamAPS FX is for prescription use only.

CamAPS FX is a mobile app.

DEKA Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the DEKA alternate controller enabled (ACE) insulin infusion pump to automatically increase, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. DEKA Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater. DEKA Loop is intended for single patient use and requires a prescription.

DEKA Loop is an interoperable Alternate Glycemic Controller (iAGC) and works to control an ACE (Alternate Controller Enabled) insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on readings from an iCGM (integrated continuous glucose monitor) and glucose values predicted by DEKA Loop. DEKA Loop can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. It is controlled by an iOS app that is downloaded to a user's iPhone.

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

Control-IQ technology (Control-IQ, the device) is a software-only device intended for the management of type 1 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 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 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, this range is changed to 112.5-120 mg/dL, and it is changed to 140-160 mg/dL during exercise mode. Control-IQ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when the 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 total daily insulin requirement, which should be established with the help of a health care provider before using the device.

The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps. A self-monitoring of blood glucose (SMBG) meter may also be used for manual input of blood glucose values to continue insulin dosing for a limited period of time when input from the iCGM is temporarily not available. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription.

The iLet Dosing Decision Software is an iAGC indicated for the management of type 1 diabetes mellitus. It autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. The iLet Dosing Decision Software is intended for the management of type 1 diabetes in people 6 years of age or older. The iLet Dosing Decision Software works in conjunction with a compatible alternate controller enabled (ACE) pump. The iLet Dosing Decision Software only requires initialization with the user's body mass (body weight). The iLet Dosing Decision Software does not require carbohydrate counting by the user or the use of carbohydrate- to-insulin ratios. Although the iLet system does not require a user to enter an exact carb amount to calculate and administer a meal bolus, it does require that the user announce the meal (e.g., breakfast, lunch, dinner) AND provide an estimated carb content as "Usual", "More", or "Less" than is routine for that meal type. The iLet Dosing Decision Software does not require any information about the user's total daily dose of insulin, basal or long-acting insulin requirements, or insulin correction factors. It is an insulin titration system that requires no insulin-dose determinations by the user or provider. During normal operation, the iLet bionic pancreas (iLet ACE Pump with the iLet Dosing Decision Software installed) autonomously responds every five minutes to a glucose signal, from an iCGM that is worn by the user, by computing a control signal that translates to a dose of insulin, which is delivered to the user through the subcutaneous (SC) route. The iLet dosing decision software has three insulin controllers (algorithms) running in parallel: an adaptive basal insulin controller, which continually adapts to each individual's basal metabolic need for insulin, an adaptive bolus controller which provides doses that are required above and beyond the basal metabolic needs, and an adaptive meal dose controller which provides insulin in response to a meal announcement. The iLet is intended to dose insulin based on CGM data. In the events where CGM stops providing glucose data to the iLet Dosing Decision Software BG-run mode feature will serve to temporarily continue insulin delivery. BG-run mode will determine and command basal insulin based on past requirements and will allow announcement of meals and entry of fingerstick BG measurements, which will be treated as iCGM data and may result in commanding administration of insulin or temporary suspension of basal insulin. BG-run mode use should always be for the shortest duration possible with the goal to resume CGM.

The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps. A self-monitoring of blood glucose (SMBG) meter may also be used for manual input of blood glucose values to continue insulin dosing for a limited period of time when input from the iCGM is temporarily not available. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription.

The iLet Dosing Decision Software is an iAGC indicated for the management of type 1 diabetes mellitus. It autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. The iLet Dosing Decision Software is intended for the management of type 1 diabetes in people 6 years of age or older. The iLet Dosing Decision Software works in conjunction with a compatible alternate controller enabled (ACE) pump. The dosing decision software includes adaptive control algorithms that autonomously and continually adapt to the ever-changing insulin requirements of each individual to enable lifelong adaptive learning. The iLet Dosing Decision Software only requires initialization with the user's body mass (body weight). The iLet Dosing Decision Software does not require carbohydrate counting by the user or the use of carbohydrate- to-insulin ratios. Although the iLet system does not require a user to enter an exact carb amount to calculate and administer a meal bolus, it does require that the user announce the meal (e.g., breakfast, lunch, dinner) AND provide an estimated carb content as "Usual", "More", or "Less" than is routine for that meal type. The iLet Dosing Decision Software does not require any information about the user's total daily dose of insulin, basal or long-acting insulin requirements, or insulin correction factors. It is an insulin titration system that requires no insulin-dose determinations by the user or provider. During normal operation, the iLet bionic pancreas (iLet ACE Pump with the iLet Dosing Decision Software installed) autonomously responds every five minutes to a glucose signal, from an iCGM that is worn by the user, by computing a control signal that translates to a dose of insulin, which is intended to be delivered to the user through the subcutaneous (SC) route. The iLet dosing decision software has three insulin controllers (algorithms) running in parallel: an adaptive basal insulin controller, which continually adapts to each individual's basal metabolic need for insulin, an adaptive bolus controller which provides doses that are required above and beyond the basal metabolic needs, and an adaptive meal dose controller which provides insulin in response to a meal announcement. The iLet is intended to dose insulin based on CGM data. In the events where CGM stops providing glucose data to the iLet Dosing Decision Software BG-run mode feature will serve to temporarily continue insulin delivery. BG-run mode will determine and command basal insulin based on past requirements and will allow announcement of meals and entry of fingerstick BG measurements, which will be treated as iCGM data and may result in commanding administration of insulin or temporary suspension of basal insulin. BG-run mode use should always be for the shortest duration possible with the goal to resume CGM.

Tidepool Loop, a mobile application with algorithm technology, is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop is intended for the management of type 1 diabetes mellitus in persons six years of age and greater. Tidepool Loop is intended for single patient use. Tidepool Loop is Rx - For Prescription Use Only.

Tidepool Loop is a mobile application with algorithm technology that works to control an ACE (Alternate Controller Enabled) insulin pump to automatically increase, and suspend delivery of basal insulin based on readings from an iCGM (integrated continuous glucose monitor) and glucose values predicted by Tidepool Loop. Tidepool Loop can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop predicts glucose levels up to 6 hours in the approximate duration of insulin action for U-100 rapid-acting insulin) based on prior iCGM readings, insulin delivery history, and user input (e.g., carbohydrate intake and exercise, and in some cases fingerstick glucose) and uses that prediction to adjust insulin delivery. Tidepool Loop can be used to adjust or suspend basal insulin delivery every 5 minutes based on actual CGM sensor and predicted glucose readings. iCGM values are automatically used by the Tidepool Loop Bolus Recommendation Tool (TLBRT) when the Tidepool Loop Algorithm technology is active, i.e. when the device is operating in closed-loop mode with an active iCGM sensor session. When closed-loop mode is off, such as when it is manually disabled or when there is no active iCGM sensor session, the Tidepool Loop Bolus Recommendation Tool (TLBRT) is disabled. The user will use Tidepool Loop's simple bolus calculator. into which iCGM values are not automatically populated into the glucose field. Users must manually enter information about carbohydrates to initiate a meal bolus. When closed-loop mode is on, recommended bolus delivery is calculated using the Tidepool Loop Bolus Recommendation Tool (TLBRT) and can be manually adjusted. The Tidepool Loop app requires that specific, initial therapy settings are established by a health care provider as part of creating the prescription order. These settings include: - Target Correction Ranges for normal operation, Pre-Meal and Workout Presets . - Carb to Insulin Ratios . - Insulin Sensitivity Factors ● - Basal Rates ● - Max Basal Rate ● - Max Bolus . Tidepool Loop uses two glucose-specific settings that may be different from the user's experience with traditional glucose monitoring or CGM therapy. These are Correction Range and Glucose Safety Limit. Correction Range is the range of glucose values that the user wants Tidepool Loop to work to bring their glucose to. Correction Range can be set as low as 87 mg/dL and as high as 180 mg/dL. Tidepool Loop will warn the user if values outside the recommended bounds of 100-115 mg/dL are selected. The user can add different Correction Ranges for different times of day. Tidepool Loop supports up to 48 Correction Range segments in a 24-hour period. Tidepool Loop allows these user-customizable target Correction Ranges: - . Normal operation - Pre-meal Preset - . Workout Preset Glucose Safety Limit (mg/dL) is a safety feature of the Tidepool Loop algorithm. If the current CGM value or any future predicted glucose value is below this safety limit. Tidepool Loop will suspend insulin delivery in an effort to prevent low glucose. The algorithm will also not recommend a bolus. Glucose Safety Limit can be set as low as 67 mg/dL. It can be set as high as 110 mg/dL or to the Correction Range minimum, whichever qlucose value is lower. Tidepool Loop will warn the user if values outside Tidepool's recommended bounds of 74 to 80 mg/dL are selected. The Glucose Safety Limit is also part of the Dosing Safety Threshold, which is part of the Tidepool Loop insulin delivery algorithm. The Dosing Safety Threshold is a period of time that has the same duration as the insulin activity duration (i.e., 6 hours). The Dosing Safety Threshold is equal to the user's Glucose Safety Limit for the first half of the insulin activity duration (i.e., 3 hours), and then increases until it is at the midpoint of the Correction Range at the end of the insulin activity duration (i.e., 6 hours). Tidepool Loop is designed to be installed on an iPhone running iOS operating systems (version 15 or higher). The Tidepool Loop application includes an optional extension for Apple Watch devices running watchOS operating system (version 6.1 or higher).