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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.