The recent acquisition of Companion Medical allows the further simplification of diabetes management and improved outcomes through dosing recommendations for the large number of people using multiple daily injections (MDI). Building upon the success of InPenTM, Medtronic will combine InPenTM smart insulin pen* capabilities with Medtronic intelligent algorithms to deliver proactive dosing advice personalized to each individual. Medtronic Diabetes Chief Medical Officer, Robert Vigersky, MD and Companion Medical’s Head of Clinical Advocacy, Janice MacLeod discussed this integration in a recent webinar.
As a first step in this process, with the latest InPenTM release, InPenTM users are now able to sync Medtronic’s GuardianTM Connect Continuous Glucose Monitoring (CGM) data in real-time with their InPenTM app. The glucose data integrates with the dose and meal data in the Insights by InPenTM reports that the patient shares with their health care team directly through the app. Future development will include integration of the InPenTM dose data into CareLinkTM software.
The 2006 Guard Control Trial1 was conducted involving patients on intensive insulin therapy, using MDI or pump therapy with some of the poorest control (A1C at the onset of the study was around 9.6%)1. Researchers investigated the impact of adding personal CGM to these groups. They had a control group in which no CGM was used, illustrated in blue in Figure 2 below. They had a group in which CGM was used three days every 2 weeks and a group in which CGM is worn by the patients 6 out of 7 days. Those patients in the control group had an A1C reduction of 0.4%, those patients who wore CGM 3 days out of every 2 weeks had an intermediate reduction, but those patients who wore CGM 6 days out of 7 had a reduction of 1%, a difference of 0.6% from the control arm. And in fact, 26% of the subjects achieved an A1C reduction of greater than 2%. Most importantly in this study, they achieved the reduction in A1C without the cost of increased hypoglycemia.
More recently the DIAMOND Trial was published in 20172. This study looked to determine the effectiveness of CGM in adults with type 1 diabetes treated with MDI. The study enrolled 158 adults with type 1 diabetes who were randomized into the control group which received usual care and the study group which added personal CGM to their management. This randomization was 2:1, CGM vs. control.
A1c was measured in both groups at baseline, 12 weeks and 24 weeks. At the end of the study the change in mean A1c was 1.0% in the CGM group vs. 0.4% in the control group – a 0.6% difference in favor of CGM leading to the conclusion that among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in A1C level during 24 weeks.
In a similarly designed trial, in this case conducted with 116 older adults (aged 60 or older) with both type 1 and type 2 using MDI, CGM use was high and associated with improved A1C and reduced glycemic variability (3). Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects.
What happens when you connect a smart insulin pen with a smart CGM system? More powerful data-driven dosing insights made possible through the Medtronic and Companion Medical collaboration offer the potential to help users proactively deliver the right dose at the right time while allowing the user to think less about their diabetes. Connected, continuous, data-driven care approaches are the future of health care and the Medtronic and Companion Medical integration bring that potential to individuals on intensive insulin therapy regardless of how the user chooses to deliver their insulin.
InPen™ system provides users with automatic tracking of insulin injections, and provides the user with tools to help take the right amount of insulin at the right time including:
InPenTM currently integrates glucose data from the following devices:
The GuardianTM Connect system is the only smart continuous glucose monitor (CGM) that helps patients on multiple daily injections outsmart high and low glucose levels. The GuardianTM Connect App allows for easy viewing of glucose levels right on the user’s smartphone and is now approved on both iOS and Android. Recent updates to the new GuardianTM Connect system include enhanced volume features, enabling more volume control, and an in-app setup wizard for simplified training. In addition, the GuardianTM Connect system offers predictive alerts. The GuardianTM Connect system uses smart technology to predict where glucose levels are headed, the system offers alerts up to 60 minutes in advance, which may help patients act or stay ahead of their diabetes. The GuardianTM Connect system is also the only stand-alone CGM system with a sensor indicated for both arm and abdomen wear.
Smart insulin pens connect to a mobile app to provide dosing calculations, reminders and CGM system integration.
Deiss D, Bolinder J, Riveline JP, Battelino T, et al. Improved Glycemic Control in Poorly Controlled Patients with Type 1 Diabetes Using Real-Time Continuous Glucose Monitoring Guard Connect Trial. Diabetes Care. 2006;29(12):2730-2732.
Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults with Type 1 Diabetes Using Insulin Injection The DIAMOND Randomized Clinical Trial. JAMA. 2017;317(4):371-378.
Ruedy KJ, Parkin CG, Riddlesworth TD, Graham C, et al. Continuous Glucose Monitoring in Older Adults with Type 1 and Type 2 Diabetes Using Multiple Daily Injections of Insulin: Results From the DIAMOND Trial. J Diab Sci & Technol. 2017;11(6):1138-1146.
Important Safety Information: GuardianTM Connect CGM 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. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. 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 important safety information.
Important Safety Information: InPenTM Smart Insulin Pen
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.
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