EPISODE 1
Consequences of Hyperglycemia and Why Tighter Management is Crucial
With Jennifer McVean, MD, Medtronic Diabetes | Kristen Scavuzzo, MS, RD, Medtronic Diabetes |
and James Thrasher, MD, FACE, Arkansas Diabetes and Endocrinology Center
An estimated 2 million Americans are living with type 1 diabetes.* How are we doing as a nation in meeting glycemic targets? In this episode, we discuss the current state of diabetes in the U.S., the risks of hyperglycemia, and why striving for tighter management is crucial.
This podcast is intended for healthcare professionals only. Dr. Thrasher is a paid consultant with Medtronic. Dr. Thrasher’s comments refer to the SmartGuard™ feature and his experience in his own clinical practice. Individual results may vary.
*
Statistics gathered from CDC National Diabetes Statistics Report
1
Ebekozien O, Mungmode A, Sanchez J, Rompicherla S, Demeterco-Berggren C, Weinstock RS, Jacobsen LM, Davis G, McKee A, Akturk HK, Maahs DM, Kamboj MK. Longitudinal Trends in Glycemic Outcomes and Technology Use for Over 48,000 People with Type 1 Diabetes (2016-2022) from the T1D Exchange Quality Improvement Collaborative. Diabetes Technol Ther. 2023 Nov;25(11):765-773. doi: 10.1089/dia.2023.0320. Epub 2023 Oct 16. PMID: 37768677.
2
Lal RA, Robinson H, Lanzinger S, Miller KM, Pons Perez S, Kovacic R, Calhoun P, Campbell F, Naeke A, Maahs DM, Holl RW, Warner J. Temporal Changes in Hemoglobin A1c and Diabetes Technology Use in DPV, NPDA, and T1DX Pediatric Cohorts from 2010 to 2018. Diabetes Technol Ther. 2022 Sep;24(9):628-634. doi: 10.1089/dia.2022.0095. PMID: 35856740; PMCID: PMC9634993.
3
Swedish Diabetes Registry: https://www.ndr.nu/#/english
4
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. doi:10.1001/jama.2016.19975
5
Carlson, A et al. Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes DIABETES TECHNOLOGY & THERAPEUTICS Volume 24, Number 3, 2022 Mary Ann Liebert, Inc. DOI: 10.1089/dia.2021.0319
6
Brown S, et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care 2021;44(7):1630–1640
7
Brown S, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med 2019; 381:1707-1717
8
Benhamou, P-Y, et al. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomized controlled crossover trial. The Lancet Digital Health Volume 1, ISSUE 1, E17-E25, May 2019.
9
Tauschmann, M, et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomized trial The Lancet Volume 392, Issue 10155, P1321-1329, October 13, 2018.
10
Bionic Pancreas Study Group. Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes N Engl J Med 2022; 387:1161-1172
11
Early Real-World Performance of the MiniMed™ 780G Advanced Hybrid Closed-Loop System and Recommended Settings Use in the United States James R. Thrasher, Arcelia Arrieta, Fang Niu, Katherine R. Cameron, Toni L. Cordero, John Shin, Andrew S. Rhinehart, and Robert A. Vigersky Diabetes Technology & Therapeutics 2024 26:S3, 24-31 https://www.liebertpub.com/doi/abs/10.1089/dia.2023.0453
Important Safety Information: MiniMed™ 780G system with SmartGuard™ Technology with Guardian™ 4 sensor
The MiniMed™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven 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™ 780GSystem includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose 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™ 780G System consists of the following devices: MiniMed™ 780G Insulin Pump, the Guardian™ 4 Transmitter, the Guardian™ 4 Sensor, One-press serter, the Accu-Chek™ Guide Link blood glucose meter, and the Accu-Chek™ Guide Test Strips. The system requires a prescription from a healthcare professional.
The Guardian™ 4 Sensor is intended for use with the MiniMed™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian™ (4) sensor is indicated for up to seven days of continuous use.
The Guardian™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ 4 sensor. The Guardian™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.
WARNING: Do not use the SmartGuard™ feature 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 the SmartGuard™ feature.
WARNING: Do not use the MiniMed™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 780G system.
WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.
Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. 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 https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library