Portfolio Perspectives

ADA Standards of Medical Care in Diabetes and Medtronic Solutions

Individualizing diabetes care is the harmony of shared decision-making between the person living with diabetes and the healthcare team who has clinical expertise and the knowledge of application of clinical evidence. Each year the American Diabetes Association (ADA) publishes their evidence-based Standards of Medical Care in Diabetes.1 Section 7 of the clinical recommendations address technology in diabetes care.2 When it comes to selection of therapy choices in managing diabetes, patients’ needs and preferences can evolve over time. Offering your patients choice of devices will individualize their care based on their circumstances, desires, and their capability to use the device safely. Medtronic Diabetes is committed to serving your patients wherever they are on their journey.

Introduction of Automated Insulin Delivery

The Standards of Medical Care in Diabetes—2022 broadened the recommendation for the use of insulin pump automated insulin delivery (AID) for not only youth and adults with type 1 diabetes (T1D), but to include anyone with insulin-deficient types of diabetes. For those not able or uninterested in AID, then non-AID insulin pump systems with or without continuous glucose monitoring (CGM) may be offered.

Aligning with this recommendation, the MiniMedTM 770G system (when used with CGM) can be used in three different ways. In SmartGuardTM Manual Mode, Suspend before low or Suspend on low can be used, while SmartGuardTM Auto Mode (AID) adjusts basal delivery based on sensor glucose readings every 5 minutes targeting glucose 120 mg/dL. This pump system is also enabled for future software upgrades. The MiniMedTM 780G system and Guardian 4 sensor have been submitted to the FDA for approval. This system technology is the next step in the goal to reduce fingersticks and bring your patients an advanced algorithm with auto-correction bolus.

Type 2 Diabetes (T2D) Insulin Taking Recommendation

An additional highlight of the Standards of Medical Care in Diabetes—2022 is the recommendation that T2D can be managed in youth and adults with insulin pump therapy. The MiniMedTM 630G provides continuous delivery of basal insulin (at user selectable rates) while offering various bolusing options (in user-selectable amounts). Besides the availability of the Bolus Wizard, the MiniMedTM 630G can be programmed with up to seven preset bolus selections, which are accessible in the bolus menu or through the remote function on the Contour® Next Link 2.4 meter. The opportunity to integrate with CGM (GuardianTM 3 sensor) is available—the optional Suspend on low sensor-augmentation can help protect against severe hypoglycemia (programmable for 60-90 mg/dL.)

Early Adaptation of CGM

The Standards of Medical Care in Diabetes—2022 state that CGM should be considered at the onset of a diabetes diagnosis that requires insulin use. Medtronic has a standalone CGM that fits this need, the GuardianTM Connect System. It is the only CGM that has the option of low/high predictive alarms from 10-60 min in advance, which provides the person with diabetes peace of mind and the critical information needed to see glucose trends as they learn to manage diabetes. The GuardianTM Connect System has a 98.5% low detection rate with predictive alerts set at 30 minutes before a low.

Introducing Connected Insulin Pens

While insulin pumps and CGM have been available for several years and a wide array of evidence exists for their use, the connected insulin pen (CIP), such as InPenTM Smart Insulin Pen, is new to this technology world. The ADA recognizes the CIP and what it can offer, such as the capability to record dose data, calculate insulin doses, give dose reminders, and be synced with CGM data. The ADA advises patients who want to use an insulin dose calculator to use one approved by the FDA—InPenTM is FDA cleared. 

Initial Training and Ongoing Support

Furthermore, the ADA Standards of Medical Care in Diabetes—2022 highlights when prescribing a device, providers should ensure that people with diabetes and/or their caregivers receive initial and ongoing education and training, including the ability to use and share data to adjust therapy. Your Medtronic Diabetes local team is dedicated to supporting your patients, while also helping you to build competencies with these technologies. Check out the Medtronic Diabetes Digital University for more information.

Medtronic’s focus is on the importance of meeting people where they are in their diabetes journey by providing them with a range of technology options. Recognizing that every person’s experience with diabetes is different, Medtronic offers a wide technology selection seeking to help people achieve their individual goals and preferences.

1

American Diabetes Association Professional Practice Committee. Diabetes Care. 2022;45 (Suppl 1) https://diabetesjournals.org/care/issue/45/Supplement_1

2

American Diabetes Association Professional Practice Committee, Draznin B, Aroda VR, et al. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S97-S112. doi:10.2337/dc22-S007

Important Safety Information: MiniMedTM 770G System with SmartGuardTM Technology

The MiniMed™ 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 770G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose (SG) values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed™ 770G system consists of the following devices: MiniMed™ 770G insulin pump, the Guardian™ Link (3) transmitter, the Guardian™ Sensor (3), one-press serter, the Accu-Chek® Guide Link blood glucose meter, and the Accu-Chek® Guide test strips. The system requires a prescription.

The Guardian™ Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3).

All therapy adjustments should be based on measurements obtained using the Accu-Chek® Guide Link blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.

WARNING: Do not use the SmartGuard™ Auto Mode for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in SmartGuard™ Auto Mode.

WARNING: Do not use the MiniMed™ 770G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 770G system.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 770G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library

Important safety information: CGM/GuardianTM Connect system

The Guardian™ Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices, and is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day, or for people who are unable or unwilling to maintain contact with their healthcare professional. The system requires a functioning mobile electronic device with correct settings in place for accurate operation. A non-functioning mobile device or incorrect settings may prevent the app from issuing alerts. Missing alerts may result in undetected low and high glucose levels.

For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at http://www.medtronicdiabetes.com/support/download-library/user-guides and www.medtronicdiabetes.com/importantsafetyinformation.