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EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient's glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing. EndoTool IV 3.1 logic is not a substitute for but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.

EndoTool IV 3.1 is a software system for glucose management which uses the current and cumulative qlucose values provided by the user to calculate and recommend intravenous insulin or carbohydrate doses, to adjust and maintain the patient's glucose level within a provider-ordered target range. In addition, the application can recommend a subcutaneous Basal transition insulin dose when IV insulin therapy is no longer required.

The InPen System is a home-use reusable pen for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen Smart Insulin pen allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient aged 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data. For an insulin dose based on amount of carbohydrates, a healthcare provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use.

The InPen App is a software application with versions that are compatible with mobile phones running the iOS or Android operating system. The App is a component of the InPen system and is used with the InPen Smart Insulin pen for the management of insulin-requiring diabetes. The InPen App communicates with the InPen Smart Insulin pen to communicate doses that are delivered by the user. The InPen App is also compatible for use with blood glucose (BG) meters, Medtronic Continuous Glucose Monitors (CGMs), and the Dexcom CGMs. The InPen App includes a dose calculator that can calculate and recommend a dose for the user to review and consider as part of following the treatment plan prescribed by the healthcare provider. The dose calculator features in the App require that a healthcare professional provide patient-specific values for various therapy settings for programming into the App prior to use by the patient. These therapy settings include glucose target(s), duration of insulin action time, insulin sensitivity factor(s), and insulin-to-carbohydrate ratio(s) or fixed insulin doses for meal types and sizes. The dose calculator feature is unavailable to the user until these patient-specific values, provided by the healthcare professional, are programmed and an InPen has been paired to the App. A healthcare provider may also provide long-acting insulin settings to be programmed into the InPen App. The App includes a logbook feature that displays the patient's recent activity related to BG values, meal types and sizes, dose calculations, doses by insulin type (rapid- or long-acting), cartridge replacement and priming. The App also provides reminders and alerts that can notify the user to check their glucose, dose insulin (for potential missed meals, correction doses, and longacting insulin doses) and log doses according to schedule, replace a cartridge, or if the insulin pen has been exposed to very low or very high temperatures. The App can generate a supplemental summary report of recent therapy information for review by the patient or healthcare professional (HCP). The InPen Cloud includes a therapy report component that the user and the health care provider (HCP) can view and print to assess the overall diabetes control and treatment plan. The report displays data based upon user and HCP-defined inputs, such as glucose, insulin and carb trended information, during the defined period, as well as dose calculator usage and alerts and reminders. The Insulin Notification Service (INS) is a subcomponent of the InPen Cloud that can receive Medtronic CGM sensor glucose measurements from the CareLink Cloud. The INS includes two algorithms that assess "real time" sensor glucose measurements to identify whether a user has missed a dose or if their glucose is rising and a correction dose is needed. If either of these conditions exist, a silent notification is sent by the INS to the InPen App. The InPen App confirms the data and can provide and visual alert to the user. The user can act on the alert by assessing their glucose levels followed by calculating a dose utilizing the InPen App dose calculator.

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

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 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.

The Insulia Bolus Companion is indicated for the management of diabetes by adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. This can be done through a dedicated, secured web portal.

Insulia Bolus Companion is a prescription device indicated for the management of diabetes, for adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data; and for healthcare professionals (HCP) having experience in the management of people with diabetes treated with bolus insulin. Insulia Bolus Companion is for prescription use and is not for over-the-counter sale. Insulia Bolus Companion includes a Bolus Calculator intended to provide direction to the patient in response to blood glucose (BG) and health events, within the scope of a preplanned treatment program prescribed by their HCP for insulin suggestions. The guidance is similar to the directions provided to patients as a part of routine clinical practice: prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. An HCP can only start using Insulia Bolus Companion after having been registered by the Manufacturer or the delegate field-support team. Insulia Bolus Companion includes three components: - · A mobile application for use by people with diabetes on commercially available smartphones (iPhone or Android) and tablets, enabling patients to document BG measurements, meals, and generate dose suggestions for bolus insulin - · A web-based application for use by HCPs in professional healthcare settings through a compatible web browser on a computer, allowing patient inclusion and patient monitoring in-person and by distance - · A secure database hosted in a private cloud environment and used to securely store patient data

BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar Rx analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information. • For bolus insulin users with type 2 diabetes, BlueStar Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insultin for a given amount of carbohydrates and/or glucose value. · For basal insulin users with type 2 diabetes, BlueStar Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the IAP and configure it for patient-specific parameters. BlueStar Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. BlueStar® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

BlueStar® (subject device) combines the existing diabetes self-management features of the predicate (BlueStar® and BlueStar® Rx, K193654) with the automatic tracking of insulin delivery functionality of the reference InPen System (K160629). BlueStar maintains all of the features of the predicate and adds the capability to connect with compatible devices connected with insulin pens via Bluetooth wireless technology. In this submission, the predicate device is being modified such that it can receive insulin dose-related data when connected to a Tempo Smart Button™ (TSB). The TSB when attached to a disposable Tempo Pen (insulin pen), can transfer dose-related data (corresponding to the brand of insulin, dose amount, date, and time) via Bluetooth® Low Energy (Bluetooth) wireless technology. BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar has two versions – BlueStar (Over the Counter, OTC) and BlueStar Rx (prescription use version). BlueStar is comprised of the following software applications (app): - iOS and Android based mobile apps for patients . - web-based app (web-portal) for HCPs ● BlueStar requires initial registration before the patient can access the software applications. BlueStar is compatible with devices including Blood Glucose Meters (BGM), Blood Pressure Monitors, Continuous Glucose Monitors (CGM) , Tempo Smart Button™ 2, Weight Scales, Activity Trackers. Data, including blood glucose values, blood pressure, medications, carbohydrates, physical activity, weight, and sleep are entered, stored and processed in the patient software applications. Data can be entered manually or automatically via Bluetooth for compatible devices. Additionally, the mobile application for patients is capable of automatically receiving, storing, processing, and displaying insulin data from the Tempo Smart Button via Bluetooth. The BlueStar apps for patients function as an information repository (logbook and Personal Health Record) and diabetes education resource (curriculum, articles, videos). Patients also receive in-the-moment coaching (Real Time Feedback messages), Pattern Reports and SMART Visit Reports that can be shared with their providers. Coaching messages are motivational, behavioral, and educational in nature and are based on data (and trends) including real-time blood glucose, blood pressure, and weight. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. Patients also receive insights based on data entered and trends detected by the app. BlueStar patient apps include a secure communication system (Message Center) as well as a medication information repository (dose and schedule). Qualified type 1 and type 2 diabetes patients have access to a bolus insulin calculator (cleared under K190013). Qualified type 2 diabetes patients have access to the Insulin Adjustment Program (IAP) to titrate long-acting basal insulin (cleared under K193654). Patients use their mobile software applications to follow their HCP's bolus insulin prescription or basal insulin titration plan. The bolus insulin calculator and basal insulin titration features are only available in BlueStar Rx for use under the direction of their HCP. The provider can review patient information, workflows and decision support information using the web-based software application for HCP. The HCP can initiate and manage basal insulin titration (IAP) and the bolus insulin calculator prescription / parameters through the web-based software application for HCP. The SMART Visit Report includes data summary, analysis, and decision support for treatment as well as psychosocial issues identified by patient survey responses within the app. The SMART Visit Report can be sent by the patient to his/her HCP from the mobile app. The HCP can also generate SMART Visit Reports from their web portal.

Digital Routines is indicated for use by healthcare providers (HCPs) and their patients - aged 21 years and older - who have type 2 diabetes. Digital Routines is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Digital Routines system analyzes and reports blood glucose test results and supports medication adherence. In addition, Digital Routines provides coaching messages (motivational, behavioral, and educational) based on blood glucose values and trends. It includes software intended for use on mobile phones (for patients) or personal computers (for HCPs) in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The following Digital Routines insulin management features are for prescription use only: · For bolus insulin users with type 2 diabetes, Digital Routines includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. The healthcare provider must activate the insulin dose calculator for patient. · For basal insulin users with type 2 diabetes, Digital Routines includes an Insulin Adjustment Program (1AP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the IAP and configure it with patient-specific parameters. Digital Routines is not intended to replace the care provided by a licensed healthcare professional, including prescriptions. diagnosis, or treatment.

The Digital Routines is a stand-alone medical software system intended to be used by patients aged 21 and older who have type 2 diabetes. Digital Routines is a new kind of approach to support in helping patients manage their type 2 diabetes. Digital Routines real-time feedback and guidance fit into daily life to help patients stay on track with their diabetes care plan. Digital Routines is accessible directly from the patient's mobile phone, but also includes the patient's HCP throughout the process. It supports the healthcare provider`s treatment plan while helping with building the patient's knowledge about diabetes and stay motivated. The device also incorporates an insulin calculator for bolus insulin users and an insulin adjustment program for basal insulin users. These features require the approval of a physician before the patient can access them. The system comprises three core software components: - the Patient Mobile Application (i) - the HCP Web Portal (ii) - the Enterprise Director Web Portal (iii) HCPs can authorize the Insulin Calculator or initiate an Insulin Adjustment Program (Rx only). The Insulin Adjustment Program is designed to help physicians and their patients with type 2 diabetes to adjust their long-acting (basal) insulin to improve diabetes management. The program works by collecting and analyzing blood glucose readings to adjust basal insulin doses according to the physician's instructions. Physicians can view and adjust their patient's treatment plan at any time, and they receive safety notifications such as if a patient experiences hypoglycemia or takes insulin doses that substantially differ from the recommended amount. The Insulin Calculator uses the physician authorized regimen to calculate the corresponding dose of bolus insulin to take based on a patient's carbs and blood glucose value. Patients eligible to use the Insulin Calculator have the option within Digital Routines to request access to it. The patient's physician must authorize the Insulin Calculator for it to be activated. Prior to using the Insulin Calculator, the patient will be required to complete in-app training on the use of the calculator. The Insulin Calculator may also include an optional Insulin on Board feature that must be authorized by the physician.

EndoTool SubQ 2.1 is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dosed on the prescribing healthcare Provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics. EndoTool SubQ 2.1 logic is not a substitute for clinical reasoning but an aid for trained healthcare professionals based on obtained glucose readings and entered clinical data. Final dose recommendations for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely upon the results provided by this software program.

EndoTool SubQ 2.1 is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with hyperglycemia including adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) and when indicated a carbohydrate dose based on the prescribing healthcare Provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics. The EndoTool® SubQ 2.1 Glucose Management system includes security, software, and technical support features. Each user has an individual User Identification (ID) and Password to access portions of the application. EndoTool SubQ 2.1 is designed to safeguard the confidentiality, integrity, and availability of electronic protected health information of patients according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rules. EndoTool SubQ 2.1 is packaged in a user friendly, stand-alone program. The application is installed on Windows Server 2008 R2 or newer. The end-user should access the application using a compatible web browser, such as Internet Explorer 9 and higher, or Google Chrome 58 and higher. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments. As EndoTool SubQ 2.1 data is time sensitive, it is also imperative that all PCs and servers be set with the correct date and time using UTC. EndoTool SubQ can utilize barcode scanning in Code 39 format (also known as Alpha39, Code 3 of 9, Code 3/9, Type 39, USS Code 39, or USD-3) for patient identification/verification.

BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. BlueStar® Rx analyzes, and reports blood glucose test results and supports medication adherence. In addition, BlueStar® Rx provides coaching messages (motivational, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information to aid in diabetes self-management. · For bolus insulin users with type 1 or type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. • For basal insulin users with type 2 diabetes, BlueStar® Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. • For bolus insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen. · For premixed insulin users with type 2 diabetes, BlueStar® Rx's IAP calculates appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin. The algorithms for the IAP are not designed for the titration of NPH, regular human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters. BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Subject device (BlueStar® Rx) is a modified version of the predicate (BlueStar® Rx cleared under K193654). BlueStar® Rx maintains the basic features / functionality of the predicate and adds the titration of fast-acting bolus insulin doses and premixed insulins for qualified type 2 diabetes patients. Qualified patients are those with type 2 diabetes whose blood glucose is not adequately managed on current insulin therapies (e.g., using basal insulin) and/or non-insulin therapies. This bolus insulin and premixed titration feature is included as part of the expanded Insulin Adjustment Program (IAP) in BlueStar® Rx. The predicate (BlueStar® Rx, K193654) is a standalone software system intended to be used by healthcare providers (HCPs) and their patients aged 18 years and older - who have type 1 or type 2 diabetes. The system is intended to assist type 1 and type 2 diabetes patients to self-manage their disease. Like the predicate, the subject device (BlueStar® Rx) is intended to provide secure capture, storage, and transmission of blood glucose data as well as other information to aid in diabetes self-management. Patients receive guidance on diabetes self-management, are encouraged to reach out to their healthcare team when needed and have access to a bolus insulin calculator. The insulin adjustment program (IAP) of the predicate (BlueStar® Rx, K193654) already includes the ability to titrate long-acting basal insulin for patients with type 2 diabetes. In this submission, fast-acting bolus insulin and premixed insulin titration features are added to the subject device's (BlueStar® Rx) IAP for patients with type 2 diabetes. Health care providers (HCPs) will be required to initiate and manage the titration of basal, bolus and premixed insulin titration for their qualified type 2 diabetes patients using the following two interfaces: - Web based HCP interface for use by the providers to prescribe insulin doses for the qualified type 2 diabetes patients. - Web and mobile patient interface for use by patients to follow provider's insulin titration plan. The IAP feature in subject device (BlueStar® Rx) provides directions to the patients based on prescription by their HCP for titrating basal, bolus and premixed insulin doses.

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetesrelated healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols. Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Insulia Diabetes Management Companion is a mobile and web-based diabetes management system for adult type 2 diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components: - A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets. - A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer. - A secure database hosted in a private cloud environment and used to securely store patient data. Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values. Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100, Lantus® U-100, Semglee® U-100, Toujeo® U-300) once daily. Insulia should not be used for: - basal dose recommendations for intermediate-acting insulin (NPH - Neutral Protamine Hagedorn); - premixed insulin Insulia should not be used in the following populations: - pregnant women; - non-adult patients; - patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy)

EndoTool IV is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool IV logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.

EndoTool IV is a software system for glucose management which uses the current and cumulative glucose values provided by the user to calculate and recommend intravenous insulin or carbohydrate doses, to adjust and maintain the patient's glucose level within a provider-ordered target range. In addition, the application can recommend a subcutaneous Basal transition insulin therapy is no longer required.