iSage Rx
Device Facts
| Record ID | K242066 |
|---|---|
| Device Name | iSage Rx |
| Applicant | Amalgam Rx, Inc. |
| Product Code | NDC · Anesthesiology |
| Decision Date | Aug 21, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1890 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Therapeutic |
Intended Use
iSage Rx™ software is indicated for use by adult patients with type 2 diabetes, and by their healthcare providers (HCP), who are seeking a digital tool to provide ongoing support for patients to understand and follow their Healthcare Providers' treatment plans for the following medications, with the goal of reaching an optimal dose of medication and/or reaching target fasting blood glucose control: - Titration of basal insulins - Titration of combinations of basal insulin and GLP-1 receptor agonists
Device Story
iSage Rx is a prescription-only, stand-alone software system comprising a patient mobile app and a web-based HCP portal. It enables HCPs to digitize and deploy basal insulin and basal insulin/GLP-1 receptor agonist titration plans. Patients input fasting blood glucose (FBG) data manually or via Bluetooth-connected glucose meters. The system uses rule-based protocols—configured by the HCP—to calculate and present insulin dose adjustments on titration days. The HCP portal allows providers to customize titration parameters, including starting dose, FBG targets, hypoglycemia thresholds, and maximum daily units. The device provides educational and coaching messages to patients. It is used in non-acute, home settings to help patients reach fasting blood glucose targets and maintenance insulin doses, potentially reducing hypoglycemic events. The system includes a white-labeled version, Dose Check, which is functionally identical.
Clinical Evidence
No clinical efficacy data provided. Human factors validation testing was conducted in simulated home and clinical environments with 15 adult patients (21+ years) with Type 2 diabetes and 17 healthcare providers (physicians, nurse practitioners, physician assistants). No training was provided prior to testing.
Technological Characteristics
Standalone software (mobile app and web portal). Rule-based titration algorithm. Connectivity via Bluetooth for wireless glucose meters. Configurable for specific geographic markets. Software documentation level: Basic.
Indications for Use
Indicated for adult patients with type 2 diabetes and their healthcare providers to support titration of basal insulins and combinations of basal insulin and GLP-1 receptor agonists. Contraindicated for patients with type 1 diabetes, gestational diabetes, or those using an insulin pump.
Regulatory Classification
Identification
A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
Predicate Devices
- iSage Rx (iSage Rx Basal Insulin Titration) (K161865)
Related Devices
- K171230 — My Dose Coach · Sanofi · May 26, 2017
- K161865 — iSage Rx (iSage Rx Basal Insulin Titration) · Isag Rx, Inc. · Mar 7, 2017
- K163099 — My Dose Coach · Sanofi, Inc. · Mar 22, 2017
Submission Summary (Full Text)
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August 21, 2024
Amalgam Rx, Inc Andy Miller VP, Reg. & Quality 1007 N. Orange St., Ste.400 Wilmington, Delaware 19801
Re: K242066
Trade/Device Name: iSage Rx Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: July 15, 2024 Received: July 15, 2024
Dear Andy Miller:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 M. 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
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# Indications for Use
| Submission Number (if known) | |
|------------------------------|--|
|------------------------------|--|
Device Name
iSage Rx
Indications for Use (Describe)
iSage Rx is indicated for use by adult patients with type 2 diabetes, and by their healthcare providers to provide ongoing support for understanding and following a titration plan for the following medications, with the goal of reaching optimal medication dose and/or target fasting blood sugar control:
-Basal insulins
-Combinations of basal insulin and GLP-1 receptor agonists
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
As required by 21 CFR 807.92 K242066
#### l. Submitter's Name and Address:
Amalgam Rx, Inc. 1007 N. Orange St., Ste.400 Wilmington, DE 19801
# Contact Person:
Andy Miller VP, Regulatory and Quality Amalgam Rx, Inc. +1-210-363-8753
### Date Prepared:
Aug 20, 2024
#### II. Device Information
| Trade/Device Name: | iSage Rx Platform |
|-----------------------------|------------------------------------------------|
| Regulation Name: | Predictive Pulmonary-Function Value Calculator |
| Device Classification Name: | Calculator, Drug Dose |
| Regulatory Number: | 21 CFR 868.1890 |
| Regulatory Class: | II |
| Product Code: | NDC |
#### lll. Predicate Device
Table 1: Predicate Device
| 510(k) Number | 510(k) Device | Manufacturer |
|---------------|------------------------------------------------|----------------|
| *K161865 | iSage Rx (iSage Rx Basal Insulin<br>Titration) | iSage Rx, Inc. |
*This predicate device has not been subject to a design related recall No reference devices were used in this submission
#### IV. Device Description:
## iSage Rx and Dose Check
iSage Rx System includes a web-based, HIPAA-compliant, password protected Health Care Provider (HCP), Account Administrated websites, and a patient mobile app. The system was designed to enable HCPs to digitize and deploy their basal insulin titration plan such that adult patients with type 2 diabetes may better understand and follow their basal insulin treatment plan through the iSage Rx app. The iSage Rx patient app is a stand-alone, prescription-use only (Rx-only) software device for use under the direction of a healthcare provider, that has the capability to titrate basal insulin and medications that combine basal insulin and GLP-1 receptor agonists, via rule-based protocols as part
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of a Titration Plan ordered by a Health Care Provider (HCP). It is intended for use in type 2 diabetes in a nonacute care setting.
The primary purpose of the iSage Rx device is to help the patient safely reach their fasting blood glucose targets and reach a maintenance dose of insulin through regular monitoring of blood glucose levels and titration of insulin doses.
Prescribing HCPs must register with the iSage Rx system before they can order the Patient Mobile Application. Once the HCP is registered, they may register their patients through the HCP portal, after which the patient receives a link to download the iSage Rx app. As part of the patient registration process, the HCP configures a titration plan specific to that patient.
The HCP can either use the evidence-based preset clinical titration plans available on the HCP portal or create their own. The preset plans are those on-label for a manufacture's drug and/or evidencebased protocols from treat-to-target studies or other patient-led titration studies.
Regardless of the plan chosen, the HCP ultimately defines or approves the following parameters of the titration plan:
- 1. Name of supported medication patient has been prescribed.
- 2. Starting dose of the supported medication
- 3. Target fasting blood glucose range.
- 4. Number of units to increase or decrease the supported medication based on an average fasting blood glucose values.
- 5. The frequency of the titration (1-7 days)
- 6. Hypoglycemia threshold. The default is any blood glucose less than 70 mg/dl, but the HCP may increase that for patients with higher risk of hypoglycemia.
- 7. Maximum daily number of units of the supported medication
Once the HCP has completed registering the patient, a text message is sent to the patient's mobile device for the patient to download the app from the App Store or Google Play Store.
After the patient has downloaded the app and onboarded through the registration process, the patient app prompts the patient every day to record their fasting blood glucose measurements and daily insulin doses. On titration day, the app calculates a fasting blood glucose average and generates an insulin dose according to the prescribed titration plan (given that the patient has recorded the required number of sequential daily fasting blood glucose values to calculate an average). From a calculated fasting blood glucose average, the app presents the new dose (if a change is required) on the titration day based on the HCP's titration plan. If enough blood glucose information has not been recorded by the patient, the dose is not changed, and the patient is informed why the dose hasn't changed and is reminded to record their fasting blood glucose values.
Patient data, either manually entered or entered via connected device, are available for view in the provider portal on the Patient Activity screen. Patients are informed of provider updates or changes to the prescribed titration plan through notifications. Using the iSage Rx app may help patients more easily understand their healthcare provider's insulin treatment plan and may help reduce the number of hypoglycemic events.
The iSage Rx Platform contains all functionality of iSage Rx and Dose Check products. iSage Rx/Dose Check is localized to the USA and contains a set of features, configured specifically for this particular
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geography based on market configurations. The following functionality are included in the USA released version of the iSage Rx Software platform:
- O Supported medications
- O Supported Clinical Titration Plans
- Supported Wireless glucometers O
- Supported Languages O
- o Supported Hypo-consumables
Dose Check is a white-labeled version of iSage Rx that is identical to iSage Rx. The two software applications are identical in function, with the difference in the user interface only. iSage Rx includes all available feature configurations, whereas Dose Check contains only those features configured for a specific geography.
#### V. Indications for Use:
iSage Rx is software indicated for use by adult patients with type 2 diabetes, and by their healthcare providers (HCP), who are seeking a digital tool to provide ongoing support for patients to understand and follow their Healthcare Providers' treatment plans for the following medications, with the goal of reaching an optimal dose of medication and/or reaching target fasting blood glucose control:
- Titration of basal insulins
- . Titration of combinations of basal insulin and GLP-1 receptor agonists
Please note that the intended use for the subject device was re-worded for clarity, consistency to the predicate and to include basal + GLP-1 Receptor Agonists as a supported medication. Footnotes were added to specify that age and supported medications listed are configurable by country, and that specific features may or may not be applicable depending on country specific regulatory approvals. These modifications do not alter the overall indications for use or risk profile of the iSage Rx Platform.
#### VI. Comparison of the Technological Characteristics with the Predicate Device:
The purpose, design, function, and intended use of the iSage Rx Platform and its white-label version Dose Check is identical to the predicate device. The iSage Rx Platform is built based on the latest minor release within iSage Rx 2.0, with minor releases being inclusive of sequential 2.X releases. Minor releases in the 2.X device have included only non-significant changes such as modifying existing functionalities, bug fixes, and minor User Interface updates. All relevant code and documentation shall be used accordingly while allowing for specific configurations, including all Dose Check variants, based on geography.
NOTE: The device, iSage Rx is currently cleared in the United States as a Class II device, Product Code NDC under a 510(k), K161865. However, the device submitted under EU MDR shall be referred to as iSage Rx Platform whose variants are iSage Rx and Dose Check.
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The iSage Rx Platform is interoperable with supported glucose meters noted in table 3 below. This interoperability is substantially equivalent to that of the predicate device in terms of the functionality enabling Bluetooth connections between the glucose meter and the device (K161865).
The following are assessment questions and answers used to aid in the assessment of Substantial equivalency:
| Question | Yes | No |
|----------------------------------------------------------------------------------------|-----|----|
| Same Indications for Use Statement? | | X |
| Do differences alter the effect or raise new issues of device safety or effectiveness? | | X |
| Same technological characteristics? | X | |
| Could the new characteristics affect safety or effectiveness? | | X |
| Descriptive characteristics precise enough? | X | |
| New types of safety or effectiveness questions? | | X |
| Accepted scientific methods exist? | X | |
| Performance data available? | X | |
| Data demonstrates equivalence? | X | |
# Table : SE Assessment Questions and Answers
There are no significant changes in the materials, design, or other features of the iSage Rx Platform as compared with the predicate device.
The following table below show the comparison between the predicate device and the device under the scope of this submission:
| Descriptive<br>Characteristic | Predicate Device | Proposed Device | Equivalent |
|----------------------------------|------------------------------------------------|---------------------------------------------------------|------------|
| Trade Name | iSage Rx (iSage Rx Basal<br>Insulin Titration) | iSage Rx Platform (iSage<br>Rx Basal Insulin Titration) | Same |
| 510(k) Number | K161865 | 510(k) under review | NA |
| Classification<br>Product Code | NDC | NDC | Same |
| Device<br>Classification<br>Name | Calculator, Drug Dose<br>(NDC) | Calculator, Drug Dose<br>(NDC) | Same |
| Device Class | Class II | Class II | Same |
# Table : Substantially Equivalency Table
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| Descriptive | Predicate Device | Proposed Device | Equivalent |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | iSage Rx (iSage Rx Basal<br>Insulin Titration) is<br>software indicated for use<br>by adult patients aged 21<br>and above who have type<br>2 diabetes and their<br>healthcare providers to<br>titrate basal insulin. iSage<br>Rx is not intended to<br>replace the care and<br>management provided by<br>a healthcare professional<br>trained in the<br>management of diabetes.<br>iSage Rx should not be<br>used by patients with<br>type 2 diabetes who are<br>also using prandial insulin<br>or patients with type 1<br>diabetes, gestational<br>diabetes, or patients<br>using an insulin pump. | iSage Rx Platform<br>software is indicated for<br>use by adult patients with<br>type 2 diabetes, and by<br>their healthcare<br>providers (HCP), who are<br>seeking a digital tool to<br>provide ongoing support<br>for patients to<br>understand and follow<br>their Healthcare<br>Providers' treatment<br>plans for the following<br>medications, with the<br>goal of reaching an<br>optimal dose of<br>medication and/or<br>reaching target fasting<br>blood glucose control:<br>Titration of basal<br>insulinsTitration of<br>combinations of<br>basal insulin and<br>GLP-1 receptor<br>agonists | Similar —Differences<br>include:<br>Added "Support for<br>the Titration of<br>combinations of<br>basal insulin and<br>GLP-1 receptor<br>agonists" as a new<br>intended use. |
| Intended Use | iSage Rx (iSage Rx Basal | iSage Rx Platform | Similar –Differences |
| | Insulin Titration) is<br>software indicated for use<br>by adult patients aged 21<br>and above who have type<br>2 diabetes and their<br>healthcare providers to<br>titrate basal insulin. iSage<br>Rx is not intended to<br>replace the care and<br>management provided by<br>a healthcare professional<br>trained in the<br>management of diabetes.<br>ISage Rx should not be<br>used by patients with<br>type 2 diabetes who are<br>also using prandial insulin<br>or patients with type 1<br>diabetes, gestational<br>diabetes, or patients<br>using an insulin pump. | software is indicated for<br>use by adult patients with<br>type 2 diabetes, and by<br>their healthcare<br>providers (HCP), who are<br>seeking a digital tool to<br>provide ongoing support<br>for patients to<br>understand and follow<br>their Healthcare<br>Providers' treatment<br>plans for the following<br>medications, with the<br>goal of reaching an<br>optimal dose of<br>medication and/or<br>reaching target fasting<br>blood glucose control:<br>Titration of basal<br>insulins Titration of<br>combinations of<br>basal insulin and<br>GLP-1 receptor<br>agonists Patients using iSage Rx<br>can record their blood<br>glucose levels, view their<br>Healthcare Provider's<br>dosing plan for supported<br>medications, and record<br>the medication dose<br>taken.<br><br>iSage Rx connects with<br>the following devices:<br>Glucose meters<br>to transmit Blood<br>Glucose (BG)<br>data | include:<br>Added "Support for<br>the Titration of<br>combinations of<br>basal insulin and<br>GLP-1 receptor<br>agonists" as a new<br>intended use. Removed<br>contraindication for<br>prandial insulin.<br>Removal of<br>contraindication for<br>use of iSage<br>Rx/Dose Check that<br>it "Should not be<br>used by patients<br>with type 2 diabetes<br>who are also using<br>prandial insulin"<br>was removed as it<br>was intended to<br>refer to titration of<br>prandial insulin.<br>There are no<br>contraindications to<br>concurrent use of<br>prandial insulin. It<br>was deemed<br>unnecessary to<br>specify a<br>contraindication for<br>each specific type of<br>insulin outside of<br>those included in<br>the intended use. |
| Descriptive<br>Characteristic | Predicate Device | Proposed Device | Equivalent |
| | | iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 1 diabetes, gestational diabetes, or patients using an insulin pump.<br><br>Note: The above intended use is applicable to the Dose Check variant as well. | |
| Device | Description | Description | Similar –Differences |
| | The iSage Rx (iSage Rx Basal Insulin Titration) is a stand-alone, Prescription Only (Rx) software system that has the capability to titrate basal insulin, if and when, the prescribing Healthcare Provider (HCP) prescribes the titration schedule.<br><br>The iSage Rx (iSage Rx Basal Insulin Titration) is comprised of a Mobile application (patient only) and Web-based application for the healthcare provider(s). The applications are called: Healthcare Provider (HCP) Web-based Application Patient Mobile Application Prescribing HCPs must register with the iSage Rx (iSage Rx Basal Insulin Titration) system before they can prescribe the Patient Mobile Application. An iSage Rx, Inc representative will assist the HCP on the phone, or in person, in registering for the portal. The HCP will receive support, including a user guide, on how to use the product to customize and prescribe validated insulin | iSage Rx Platform is a stand-alone, prescription-use only (Rx-only) software device that has the capability to titrate basal insulin and medications that combine basal insulin and GLP-1 receptor agonists, via rule-based protocols as part of a Titration Plan ordered by a Health Care Provider (HCP). Upon input of required fasting blood glucose data, the device generates an insulin dose according to the prescribed titration plan. Patients record their Fasting Blood Sugar (FBS) daily and the dose presented follows the prescribed protocol. Patient data, either manually entered or entered via connected device, are available for view in the provider portal on the Patient Activity screen. Patients are informed of provider updates or changes to the prescribed titration plan through notifications.<br><br>The iSage Rx Platform contains all functionality of iSage Rx and Dose Check products. iSage Rx/Dose Check is localized to contain a set of features, configured specifically for a particular geography | include Configurability of features for specific geographies |
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| titration algorithms for | based on market | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| their patients. | configurations. The | |
| | following are some of the | |
| After the HCP is | key features that are | |
| registered, an email will | dependent on the | |
| be sent with a link to the | specific national market: | |
| HCP Web-based<br>Application and a<br>temporary password.<br>When HCP clicks on the<br>link, he or she will be<br>prompted to change the<br>temporary password.<br>Once a new password is<br>created, the HCP will be<br>able to login to the HCP<br>Web-based Application<br>with the new password | Supported medications Supported Clinical Titration<br>Protocols Supported Wireless<br>glucometers Supported Languages Supported Hypo-<br>consumables Adult age<br>definition | |
| and the username (i.e., | | |
| his or her registered email | | |
| address). | | |
| The HCP Web-based<br>Application is used by<br>HCPs to 1) choose from<br>and customize a patient's | Dose Check is a white-<br>labeled version of iSage<br>Rx that is identical to<br>iSage Rx. The two<br>software applications are | |
| basal insulin treatment | identical in function, with | |
| plan, 2) prescribe the | the difference in the user | |
| basal insulin treatment | interface only. iSage Rx | |
| plan, 3) review patient | includes all available | |
| entered data, and 4) | feature configurations, | |
| make adjustments to the | whereas Dose Check | |
| patient's treatment plan.<br>In order to help the HCP | contains only those<br>features configured for a | |
| create a basal insulin | specific geography. The | |
| treatment plan for a | table in Appendix C. of | |
| patient, the HCP is | this document presents a | |
| presented with a list of | comparison of iSage Rx | |
| clinically validated | and the Dose Check | |
| titration algorithms to | software applications. | |
| select from, along with | | |
| appropriate links to the<br>study evidence that | | |
| | | |
| supports each of the<br>titration<br>algorithms¹. This<br>promotes transparency<br>into exactly how the<br>titration algorithm works<br>for the HCPs. In addition,<br>the HCP is also presented<br>with an option to create a<br>custom titration<br>algorithm tailored for his<br>or her patient. The HCP<br>can view and adjust all<br>required data inputs to<br>the titration algorithms,<br>including elements such<br>as:<br>• the starting dose of<br>basal insulin (based on<br>the manufacturer's<br>labeling);<br>• a patient's fasting<br>Blood Glucose (BG)<br>targets;<br>• a hypoglycemic range<br>and insulin dose<br>adjustment<br>• the titration schedule<br>(frequency);<br>• a titration scale and<br>insulin dose adjustment<br>• the maximum number<br>of basal units per day<br>(maximum dosage of<br>basal insulin) based upon<br>his/her patient's profile.<br><br>After a HCP registers<br>patients in the HCP Web-<br>based Application, the<br>patient receives an SMS<br>notification, which<br>provides the link to<br>download the Patient | | |
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| Descriptive | Predicate Device | Proposed Device | Equivalent…
