Welldoc® App Indications for Use

The Welldoc® App combines the FDA cleared medical device functionality of Welldoc Diabetes and Welldoc Diabetes Rx with other non-FDA cleared wellness and educational/selfmanagement products.

Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, 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.

Welldoc Diabetes Rx adds the following prescription use only insulin management features::

  • For bolus insulin users with type 1 or type 2 diabetes, Welldoc Diabetes 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, Welldoc Diabetes 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. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
  • For bolus insulin users with type 2 diabetes, the Welldoc Diabetes Rx 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, the Welldoc Diabetes Rx 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.

Welldoc Diabetes and Welldoc Diabetes Rx are not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

*Insulin Dose Calculator may also be referred to as Insulin Calculator

Other Welldoc® App Non-Diabetes Functions Hypertension, Heart Failure, Behavioral Health, Prediabetes The other disease state-focused products in the Welldoc App are non-FDA-cleared wellness and educational/self-management products and DO NOT interact with Welldoc Diabetes or Welldoc Diabetes Rx functions. They are intended to help people with hypertension, heart failure, or mild mental health conditions better manage and live well. Visit www.welldoc.com for full labeling information.

BlueStar® Indications for use

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 selfmanagement. 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 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.

The following BlueStar insulin management features are for prescription use only:

  • For bolus insulin users with type 1 or type 2 diabetes, BlueStar 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 glucose value.
  • For basal insulin users with type 2 diabetes, BlueStar 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. The healthcare provider must activate the IAP and configure it with patient-specific parameters.
  • For bolus insulin users with type 2 diabetes, the BlueStar 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, the BlueStar 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.

BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

*Insulin Dose Calculator may also be referred to as Insulin Calculator

small_c_popup.png

Taking Diabetes Self-Management to the Next Level