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The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application such as the myTempo App (App). The Tempo Smart Button is indicated for single-patients 18 years or older who are: - . diagnosed with type 1 or type 2 diabetes mellitus, - using prefilled insulin Tempo Pens [Basaglar® Tempo Pen (insulin glargine) injection 100 units/mL, Lyumjev® - Tempo Pen (insulin lispro-aabc) injection 100 units/mL, Humalog® Tempo Pen (insulin lispro injection) 100 units/mL], - using a compatible application (App).

The Tempo Smart Button is a reusable data transmitter that detects and stores insulin doserelated data when attached to a disposable Tempo Pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology. The insulin dose-related data is used by the mobile application which can display the brand of insulin, dose amount, date, and time. Additionally, the Tempo Smart Button is available as part of a Welcome Kit. The Tempo Welcome Kit and Refill Kit provide the convenience of having a single kit that contains devices needed for insulin administration and blood glucose monitoring.

The Go Dose System, comprised of the Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient. Go Dose Pro applications are not intended to replace the care provided by a licensed health care provider or to provide any diagnosis on patient blood glucose values. Go Dose Pro applications are for prescription use only. Go Dose is for prescription use only by persons who are: - Diagnosed with type 2 diabetes mellitus (DM) - Aged 18-85 years - Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin - Requiring treatment intensification with Humalog 100 units per mL (U-100) - For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate Go Dose should be used multiple times per day, as directed by your healthcare provider, for entering blood glucose values and getting Humalog dosing recommendations. The Go Dose daily adjusted dosing algorithm was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL. Go Dose Pro is intended for use by health care providers who have experience prescribing mealtime insulin, including providing direction to patients within the scope of a preplanned treatments to prescribed insulin. Health care providers should use the Go Dose Pro to aid in the review, analysis and evaluation of historical blood glucose test values to support diabetes management in patients that meet the following criteria: - Diagnosed with type 2 diabetes mellitus (DM) - Aged 18-85 years - Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin - Requiring treatment intensification with Humalog 100 units per mL (U-100) - For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate The Go Dose design is based on a dosing algorithm that was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

The Go Dose System, comprised of Go Dose Pro mobile medical applications (apps), aids patients under the supervision of their health care provider (HCP) in the management of type 2 diabetes mellitus (T2DM). This medical device system is based on a "paper-based" algorithm approach that was studied for safety and efficacy in 2 multinational, multicenter, randomized, open-label, parallel-group studies within a single clinical trial, F3Z-MC-IOQC (Trial IOQC) as described in Edelman et al. 2014. This study enrolled adult patients with T2DM who were not under glycemic control after optimizing the dose of insulin glargine for fasting blood glucose, with or without metformin. The medical device provides HCPs and patients with an evidence-based approach to initiate and titrate Humalog® 100 units/mL (insulin lispro) therapy for patients continuing insulin glargine, with or without metformin. The HCP determines the meal selection for Humalog titration and the Go Dose Pro app, and sends the dose recommendation to the patient's Go Dose app. The patient uses the Go Dose app to view the initial dose recommendation. The Go Dose app uses blood glucose values manually entered by the patient as an input to determine ongoing individualized dose recommendations. This titration process continues until the HCP determines that the dose can be stabilized (i.e., no further titration required) or stopped (i.e., discontinue that dose). At that point, the HCP will determine whether to select a new meal for dose titration, stop any additional use of the Go Dose System, or select additional stable pre-meal dose(s).

HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL cartridges using disposable pen needles (sold separately).

The HumaPen Savvio is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.

HumaPen Ergo II is a reusable insulin Pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).

The HumaPen Ergo II is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.

HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).

The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately). The pen injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.

The HumaPen Luxura HD is a reusable pen injector designed for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

HumaPen Luxura HD is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3.0 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).

The HumaPen Memoir is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of insulin (Humalog® and Humulin®) and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose in one-unit increments up to 60 units.

HumaPen Memoir is a reusable mechanical pen-injector with electronic display designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company Humalog and Humulin 3.0 mL cartridges and single-use, detachable and disposable pen needles (supplied separately).