Continuous glucose monitoring (CGM) is an extraordinary tool that provides visibility into real-time glucose readings. Research has consistently demonstrated the benefits of CGM use, including reduction in hypoglycemia and patient-reported fear of hypoglycemia.1,2,3 As such, the 2023 ADA Standards of Care recommend that CGM is offered to adults and youth with type 1 or type 2 diabetes (T1D or T2D) using multiple daily injections (MDI), continuous subcutaneous insulin infusion (CSII/ pump therapy), or basal insulin.4 With the supporting evidence and clinical recommendations in support of CGM use, the T1D Exchange reported that in 2021, CGM use among individuals with T1D in the United States rose to 72%.5
Despite this growing adoption of CGM, a majority of individuals using MDI struggle to achieve the HbA1c target of 7.0% or less. Foster and colleagues reported on data from T1D Exchange from two time periods, 2010-2012 and 2016-2018, and found that mean HbA1c had increased for the more recent cohort.6
Multiple studies evaluating CGM use among individuals with T1D and T2D diabetes have demonstrated improvements in glycemic outcomes with CGM use, but these improvements fall short of standard glycemic targets.1,2,7 In fact, studies cite that only 18% to 50% of people using CGM with MDI are achieving an HbA1c of 7% or less.1,2,7
Successful diabetes management requires more than awareness of real-time glycemic levels. A study of pediatric individuals with T1D identified six habits that are positively associated with glycemic outcomes.8 Four of these six habits are related to insulin delivery, demonstrating the importance of ensuring that individuals with diabetes have the support they need to manage the complexity of insulin therapy. With use of CGM and MDI therapy, patients may struggle with these four behaviors. With the use of an insulin pump or smart insulin pen, patients may feel more supported in managing a complicated insulin regimen by using the dose reminders, calculator, automatic tracking, and reports.
The ADA recommends offering Automated Insulin Delivery (AID) therapy to all people with T1D (youth and adults), and people with other types of insulin-deficient diabetes who are able to use the devices safely.4 For those not choosing AID, smart insulin pens (SIP) provide an option to support them beyond CGM alone.
Smart MDI system (used with CGM) can provide the data and insights needed to support both patients and healthcare providers in delivering the right amount of insulin when it is needed. The InPen™ smart insulin pen system automatically logs insulin doses, leverages previous dosing data and current CGM data to calculate insulin doses, and reminds patients to deliver an insulin dose when one may have been missed. Healthcare providers can use the reports to better understand a patient’s dosing habits and adjust therapy recommendations as needed based not only on glucose levels, but also on dosing data. This support in managing a complex insulin dosing regimen has the potential to support patients and healthcare providers in reaching target glycemic outcomes.9
Beck RW, Riddlesworth T, Ruedy K, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017;317(4):371–378.
Gilbert TR, Noar A, Blalock O, Polonsky WH. Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. Diabetes Technol Ther. 2021;23(S1):S35-S39.
Heinemann L, Freckmann G, Ehrmann D, et al. Real-Time Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Impaired Hypoglycaemia Awareness or Severe Hypoglycaemia Treated with Multiple Daily Insulin Injections (HypoDE): A Multicentre, Randomised Controlled Trial. Lancet. 2018;391:1367-1377.
ElSayed NA, Aleppo G, Aroda VR, et al., on behalf of the American Diabetes Association. 7. Diabetes Technology: Standards of Care in Diabetes-2023. Diabetes Care. 2023;46(S1):S111-S127.
Ebekozien O, Mungmode A, Miyazaki B, et al. Longitudinal Trends in CGM and Pump Use: Real-World Data from the T1D Exchange QI Collaborative. Diabetes. 2022;71(S1):911-P.
Foster NC, Beck RW, Miller KM, et al. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019;21(2):66-72.
Beck RW, Riddlesworth T, Ruedy K, et al. Continuous Glucose Monitoring versus Usual Care in Patients with Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017;167:365–374.
Lee JM, Rusnak A, Garrity A, et al. Feasibility of Electronic Health Record Assessment of 6 Pediatric Type 1 Diabetes Self-management Habits and Their Association with Glycemic Outcomes. JAMA Netw Open. 2021;4(10):2131278.
Ospelt E, Noor N, Sanchez J, et al. Facilitators and Barriers to Smart Insulin Pen use: A Mixed-Method Study of Multidisciplinary Stakeholders from Diabetes Teams in the United States. Clin Diabetes. 2023;41(1)56-67.
Important safety information: InPen™
The InPen requires a prescription. It is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 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 injector 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 age 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 professional must 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 professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
For additional product and important safety considerations, see User Guide and http://bit.ly/InPenSafety
Important safety information: Continuous Glucose Monitoring
Continuous Glucose Monitoring systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with risks associated with the use of these systems. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a home glucose meter. A confirmatory fingerstick is required prior to making adjustments to diabetes therapy. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. Please visit www.medtronicdiabetes.com/importantsafetyinformation for additional details.