(57 days)
Not Found
No
The document describes "adaptive" algorithms and "insulin titration system" but does not explicitly mention or provide details about the use of AI or ML techniques. The algorithms are described as responding to glucose signals and adapting to individual needs, which could be achieved through traditional control algorithms without necessarily employing AI/ML.
Yes
The device is described as "iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus" and "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." This directly indicates its role in managing a disease, which falls under the definition of a therapeutic device.
No
The device is an insulin dosing decision software that determines and commands insulin delivery based on CGM input, meal announcements, and self-monitoring of blood glucose. It is intended for the management of type 1 diabetes by titrating insulin, not for diagnosing the condition itself.
No
The device description explicitly states that the iLet Dosing Decision Software "works in conjunction with a compatible alternate controller enabled (ACE) pump" and that 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." This indicates a necessary hardware component (the pump) for the device's function, making it not solely software.
Based on the provided text, the iLet Dosing Decision Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- iLet Function: The iLet Dosing Decision Software uses data from a continuous glucose monitor (CGM) and potentially manual blood glucose inputs to autonomously determine and command insulin doses. It is a decision-making and control system for insulin delivery, not a device that analyzes biological specimens.
The text clearly describes the iLet as an "iAGC indicated for the management of type 1 diabetes mellitus" and focuses on its role in controlling an insulin pump based on glucose readings. It does not perform any analysis of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QJI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
6 years of age or older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Insulin-Only Bionic Pancreas Extension Study was an extension study for adults and children >6 years old with type 1 diabetes (T1D) who participated in the Standard Care Group (control group) in a prior 13-week multi-center, parallel group randomized controlled trial (RCT) that compared the SC Group with a group using the insulin-only (IO) configuration of the iLet Bionic Pancreas (BP) System. In the Extension Study, the RCT SC group had the opportunity to use the IO configuration of the iLet BP System for 13 weeks. The clinical study used to support the safety of Fiasp® PumpCart® (insulin aspart) in a prefilled 1.6mL cartridge with the iLet was obtained in a 13-week, single-arm clinical study that included 46 users 6-17 years of age. The clinical study was an extension study of the insulin only RCT. Participants of the SC arm of the RCT transitioned to use of the iLet with Fiasp in the extension phase, a 13-week single-arm intervention trial (extension of randomized controlled trial [RCT] for the control group) with 90 total participants with Type 1 diabetes at 16 clinical sites in the United States (46 participants 6-17 years of age).
Methods: Participants were trained on use of the BP. Participants 6-17 years of age used U-100 Fiasp® PumpCart® (insulin aspart) in a pre-filled 1.6mL cartridge.
Phone contacts occurred after 1-2 days and 7 (±2) days and visits occurred at 2 weeks (±4 days), 6 weeks (±4 days), 10 weeks (±4 days), and 13 weeks (±4 days). Visits could be conducted virtually. At the 13-week visit, a blood sample was obtained for central lab HbA1c determination and psychosocial questionnaires were completed.
Endpoints: All participants who initiated use of the BP with Fiasp were included in the analyses. The 13-week HbA1c measurement at the end of the RCT and the 13 weeks of CGM data during the RCT were used as baseline metrics for the analyses. For outcomes, HbA1c was measured at the end of 13 weeks and CGM data were collected over the full 13 weeks.
Participants 6-17 Years of Age Results: 46 of the 48 participants 6-17 years of age initiated BP with Fiasp and were included in this analysis. In the 6-17 years of age cohort of the extension study which used Fiasp with the iLet, the study found a decrease in HbA1c from baseline to 13 weeks of 0.56%. There was an increase in time in range (TIR) from baseline by 12.0% and mean glucose decreased by 18 mg/dL. These changes occurred without an increase in CGM-measured time 180 mg/dL
- Time >250 mg/dL
- Hyperglycemic event rate
- Time
§ 862.1356 Interoperable automated glycemic controller.
(a)
Identification. An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect (
e.g., more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events.
(ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices.
(iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to (
e.g., specification of glucose sensor performance) or accept commands from (e.g., specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices.
(vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place (
e.g., validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller.
(2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures to address device system hazards;
(ii) Design decisions related to how the risk control measures impact essential performance; and
(iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to connected devices;
(ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices;
(iii) Sharing of necessary state information between the controller and any connected devices (
e.g., battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified;
(v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and
(vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance.
(4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include:
(i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices;
(ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices (
e.g., infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and
(iv) Connectivity events (
e.g., establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section.
(6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section.
(7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable.
(8) The labeling required under § 809.10(b) of this chapter must include:
(i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part.
(ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe.
(iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate.
(iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section.
(v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate.
(vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section.
(vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
September 22, 2023
Beta Bionics, Inc. Liz Cooper Senior Regulatory Affairs Specialist 300 Baker Avenue, Suite 301 Concord, MA 01742
Re: K232224
Trade/Device Name: iLet® Dosing Decision Software Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: QJI Dated: July 26, 2023 Received: July 27, 2023
Dear Liz Cooper:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Joshua Balsam -S
Joshua Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232224
Device Name iLet® Dosing Decision Software
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 510(k) K232224 Summary: Device Modification
iLet Dosing Decision Software
| Prepared: September 22, 2023 | |
|---|---|
| Company: | Beta Bionics, Inc. |
| 300 Baker Avenue, Ste. 301, Concord, MA 01742 | |
| (978) 602-6239 | |
| Contact Person: | Liz Cooper |
| Senior Regulatory Affairs Specialist | |
| lcooper@betabionics.com | |
| (732) 275-5848 | |
| Product Trade Name: | iLet® Dosing Decision Software |
| Common Name: | Interoperable Automated Glycemic Controller (iAGC) |
| Classification Name: | Interoperable automated glycemic controller |
| Regulation Number, Device Class and Pro Code: | 21CFR 862.1356, Class II, QJI |
| Predicate Device: | iLet® Dosing Decision Software (Beta Bionics, Inc., K220916) |
Purpose of 510(k) Notification:
The User Guide and Quick Reference Guide are being updated to expand the indications for use of the iLet bionic pancreas with U-100 Fiasp® PumpCart® (insulin aspart) in a pre-filled 1.6mL cartridge to include people 6 years of age or older with diabetes mellitus.
No changes have been made to the technological characteristics of the device.
Indications for Use:
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.
Device Description and Principle of Operation:
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
4
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.
| Element of
Comparison | iLet Dosing Decision Software
(Predicate Device - K220916) | Subject Device |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Intended Use | An iAGC which is intended to work with an iCGM and ACE pump to
increase, decrease, or suspend delivery of insulin for management of type
l diabetes | Identical |
| Fiasp Age
Indication | People 18 years of age or older | People 6 years of
age or older |
| Communication | Communicates with an ACE pump | Identical |
| Required user
input settings | User's weight | Identical |
Comparison of the Modified Device to the Cleared Device
5
| Element of
Comparison | iLet Dosing Decision Software
(Predicate Device - K220916) | Subject Device |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| | 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.
No meal announcement is advised if a meal contains a very small
amount of carbohydrates (approximately less than a quarter of usual). | |
| Maximum Basal
Rate | 0 - 11.5 units/hr | Identical |
| BG Target Value | CGM targets of 110 mg/dL, 120 mg/dL and 130 mg/dL | Identical |
| Maximum Bolus
Size | 24 units for meal announcement, 30 units overall. | Identical |
| Maximum
Automatic Bolus
Size | 3 units in response to CGM glucose, 6 units in response to isolated BG
when CGM is offline | Identical |
Discussion of Clinical Testing
The Insulin-Only Bionic Pancreas Extension Study was an extension study for adults and children >6 years old with tvpe 1 diabetes (T1D) who participated in the Standard Care Group (control group) in a prior 13-week multi-center, parallel group randomized controlled trial (RCT) that compared the SC Group with a group using the insulin-only (IO) configuration of the iLet Bionic Pancreas (BP) System. In the Extension Study, the RCT SC group had the opportunity to use the IO configuration of the iLet BP System for 13 weeks. The clinical study used to support the safety of Fiasp® PumpCart® (insulin aspart) in a prefilled 1.6mL cartridge with the iLet was obtained in a 13-week, single-arm clinical study that included 46 users 6-17 years of age. The clinical study was an extension study of the insulin only RCT. Participants of the SC arm of the RCT transitioned to use of the iLet with Fiasp in the extension phase, a 13-week single-arm intervention trial (extension of randomized controlled trial [RCT] for the control group) with 90 total participants with Type 1 diabetes at 16 clinical sites in the United States (46 participants 6-17 years of age).
Methods: Participants were trained on use of the BP. Participants 6-17 years of age used U-100 Fiasp® PumpCart® (insulin aspart) in a pre-filled 1.6mL cartridge.
Phone contacts occurred after 1-2 days and 7 (±2) days and visits occurred at 2 weeks (±4 days), 6 weeks (±4 days), 10 weeks (±4 days), and 13 weeks (±4 days). Visits could be conducted virtually. At the 13-week visit, a blood sample was obtained for central lab HbA1c determination and psychosocial questionnaires were completed.
Endpoints: All participants who initiated use of the BP with Fiasp were included in the analyses. The 13-week HbA1c measurement at the end of the RCT and the 13 weeks of CGM data during the RCT were used as baseline metrics for the analyses. For outcomes, HbA1c was measured at the end of 13 weeks and CGM data were collected over the full 13 weeks.
Key outcomes:
- . HbA1c
6
- Mean CGM glucose ●
- Time 70-180 mg/dL ●
- Time >180 mg/dL ●
- Time >250 mg/dL ●
- Hyperglycemic event rate
- Time