Abstract
Objective
To evaluate the off-label use of the MiniMed™ 780G system in children under seven years old, as clinical outcomes in this age group are less well-established, despite the improvements in glycemic control seen with MiniMed™ 780G therapy.
Methods
Children under seven years old with type 1 diabetes using MiniMed™ 780G pump therapy were compared with children of similar age and gender using MiniMed™ 640G insulin pump therapy and multiple-dose insulin therapy with continuous glucose monitoring systems (CGMs). CGM metrics, total daily insulin (TDI) dose, and hemoglobin A1c (HbA1c) levels were evaluated retrospectively at baseline and at the 3rd, 6th, and 12th months.
Results
At the initiation of MiniMed™ 780G therapy, the mean age was 5.25±1.22 years (range: 2.8-6.8 years), and the mean TDI was 10.12±4.34 U/day (range: 4.5-17.0 U/day). The glucose management indicator and HbA1c remained lower in the MiniMed™ 780G group at the 3rd, 6th, and 12th months compared to baseline (p=0.009 and p<0.001, respectively). In the MiniMed™ 780G group, time above range (TAR) was significantly lower at the 3rd, 6th, and 12th months (p=0.018, p=0.017 and p=0.04, respectively) while time in range (TIR) was higher at the 3rd, and 12th months (p=0.026 and p=0.019, respectively) compared to other groups. The coefficient of variation (CV) of the sensor glucose and HbA1c were lower at the 12th month (p=0.008 and p=0.015, respectively) compared to both other groups. No instances of ketoacidosis or severe hypoglycemic events were observed in any of the children during the follow-up period.
Conclusion
The absence of significantly higher levels of hypoglycemia compared to other groups at any time point, along with a significant decrease in TAR across all time points, a significant increase in TIR at the 3rd and 12th months, and a significant decrease in HbA1c and CV suggests that the MiniMed™ 780G system is both safe and effective for children under seven years old.
Keywords: Automated delivery system, diabetes, diabetes mellitus, endocrinology, predictive low glucose suspension
Read the full text
5 sections · 2 figures · 2 tables · PDF
Create your free account to read the full text.
- Full text with figures and tables
- PDF and supplementary files
- Access on every Galenos journal
One Galenos account works on every Galenos journal site.
References
Lawrence JM, Divers J, Isom S, Saydah S, Imperatore G, Pihoker C, Marcovina SM, Mayer-Davis EJ, Hamman RF, Dolan L, Dabelea D, Pettitt DJ, Liese AD; SEARCH for Diabetes in Youth Study Group. Trends in prevalence of type 1 and type 2 diabetes in children and adolescents in the US, 2001-2017. JAMA. 2021;326:717-727.
Dovc K, Boughton C, Tauschmann M, Thabit H, Bally L, Allen JM, Acerini CL, Arnolds S, de Beaufort C, Bergenstal RM, Campbell F, Criego A, Dunger DB, Elleri D, Evans ML, Fröhlich-Reiterer E, Hofer S, Kapellen T, Leelarathna L, Pieber TR, Rami-Merhar B, Shah VN, Sibayan J, Wilinska ME, Hovorka R; APCam11, AP@Home, and KidsAP Consortia. Young children have higher variability of insulin requirements: observations during hybrid closed-loop insulin delivery. Diabetes Care. 2019;42:1344-1347. Epub 2019 May 21.
American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021;44:S180-S199.
2023 SWEET Benchmarking Reports. Available from: https://www.sweet-project.org/benchmarking-reports.php
Streisand R, Monaghan M. Young children with type 1 diabetes: challenges, research, and future directions. Curr Diab Rep. 2014;14:520.
Van Name MA, Hilliard ME, Boyle CT, Miller KM, DeSalvo DJ, Anderson BJ, Laffel LM, Woerner SE, DiMeglio LA, Tamborlane WV. Nighttime is the worst time: parental fear of hypoglycemia in young children with type 1 diabetes. Pediatr Diabetes. 2018;19:114-120. Epub 2017 Apr 21.
Mauras N, Buckingham B, White NH, Tsalikian E, Weinzimer SA, Jo B, Cato A, Fox LA, Aye T, Arbelaez AM, Hershey T, Tansey M, Tamborlane W, Foland-Ross LC, Shen H, Englert K, Mazaika P, Marzelli M, Reiss AL; Diabetes Research in Children Network (DirecNet). Impact of type 1 diabetes in the developing brain in children: a longitudinal study. Diabetes Care. 2021;44:983-992. Epub 2021 Feb 10.
Desrochers HR, Schultz AT, Laffel LM. Use of diabetes technology in children: role of structured education for young people with diabetes and families. Endocrinol Metab Clin North Am. 2020;49:19-35.
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;25:765-773. Epub 2023 Oct 16.
van den Boom L, Karges B, Auzanneau M, Rami-Merhar B, Lilienthal E, von Sengbusch S, Datz N, Schröder C, Kapellen T, Laimer M, Schmid SM, Müller H, Wolf J, Holl RW. Temporal trends and contemporary use of ınsulin pump therapy and glucose monitoring among children, adolescents, and adults with type 1 diabetes between 1995 and 2017. Diabetes Care. 2019;42:2050-2056. Epub 2019 Sep 5.
Petrovski G, Al Khalaf F, Campbell J, Umer F, Almajaly D, Hamdan M, Hussain K. One-year experience of hybrid closed-loop system in children and adolescents with type 1 diabetes previously treated with multiple daily injections: drivers to successful outcomes. Acta Diabetol. 2021;58:207-213. Epub 2020 Oct 12.
Abraham MB, de Bock M, Smith GJ, Dart J, Fairchild JM, King BR, Ambler GR, Cameron FJ, McAuley SA, Keech AC, Jenkins A, Davis EA, O’Neal DN, Jones TW; Australian Juvenile Diabetes Research Fund Closed-Loop Research group. Effect of a hybrid closed-loop system on glycemic and psychosocial outcomes in children and adolescents with type 1 diabetes: a randomized clinical trial. JAMA Pediatr. 2021;175:1227-1235.
Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Cherñavvsky D, Wadwa RP; iDCL Trial Research Group. A randomized trial of closed-loop control in children with type 1 diabetes. N Engl J Med. 2020;383:836-845.
Pulkkinen MA, Varimo TJ, Hakonen ET, Harsunen MH, Hyvönen ME, Janér JN, Kiiveri SM, Laakkonen HM, Laakso SM, Wehkalampi K, Hero MT, Miettinen PJ, Tuomaala AK. MiniMed 780G™ in 2- to 6-year-old children: safety and clinical outcomes after the first 12 weeks. Diabetes Technol Ther. 2023;25:100-107. Epub 2022 Dec 30.
Abraham MB, Smith GJ, Dart J, Davis EA, Jones TW. Clinical outcomes with MiniMedTM 780G advanced hybrid closed-loop therapy in 2- to 6-year-old children with type 1 diabetes. Diabetes Technol Ther. 2024;26:341-345. Epub 2024 Mar 8.
Annan SF, Higgins LA, Jelleryd E, Hannon T, Rose S, Salis S, Baptista J, Chinchilla P, Marcovecchio ML. ISPAD Clinical Practice Consensus Guidelines 2022: Nutritional management in children and adolescents with diabetes. Pediatr Diabetes. 2022;23:1297-1321. Epub 2022 Dec 5.
Sundberg F, deBeaufort C, Krogvold L, Patton S, Piloya T, Smart C, Van Name M, Weissberg-Benchell J, Silva J, diMeglio LA. ISPAD Clinical Practice Consensus Guidelines 2022: managing diabetes in preschoolers. Pediatr Diabetes. 2022;23:1496-1511.
Ajjan RA, Cummings MH, Jennings P, Leelarathna L, Rayman G, Wilmot EG. Optimising use of rate-of-change trend arrows for insulin dosing decisions using the FreeStyle Libre flash glucose monitoring system. Diab Vasc Dis Res. 2019;16:3-12. Epub 2018 Sep 3.
Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Nørgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42:1593-1603. Epub 2019 Jun 8.
Lendínez-Jurado A, López-Siguero JP, Gómez-Perea A, Ariza-Jiménez AB, Becerra-Paz I, Tapia-Ceballos L, Cruces-Ponce C, Jiménez-Hinojosa JM, Morcillo S, Leiva-Gea I. Pediatric type 1 diabetes: is age at onset a determining factor in advanced hybrid closed-loop ınsulin therapy? J Clin Med. 2023;12:6951.
Beato-Víbora PI, Chico A, Moreno-Fernandez J, Bellido-Castañeda V, Nattero-Chávez L, Picón-César MJ, Martínez-Brocca MA, Giménez-Álvarez M, Aguilera-Hurtado E, Climent-Biescas E, Azriel-Mir S, Rebollo-Román Á, Yoldi-Vergara C, Pazos-Couselo M, Alonso-Carril N, Quirós C. A multicenter prospective evaluation of the benefits of two advanced hybrid closed-loop systems in glucose control and patient-reported outcomes in a real-world setting. Diabetes Care. 2024;47:216-224.
Pulkkinen MA, Varimo TJ, Hakonen ET, Hero MT, Miettinen PJ, Tuomaala AK. During an 18-month course of automated insulin delivery treatment, children aged 2 to 6 years achieve and maintain a higher time in tight range. Diabetes Obes Metab. 2024;26:2431-2438. Epub 2024 Mar 21.
Tornese G, Carletti C, Lanzetta MA, Tamaro G, Barbi E, Faleschini E. Safety of real-life usage of advanced hybrid closed-loop system minimed 780G in children with type 1 diabetes younger than 7 years old. Diabetes Care. 2023;46:e123-e125.
Bergenstal RM, Beck RW, Close KL, Grunberger G, Sacks DB, Kowalski A, Brown AS, Heinemann L, Aleppo G, Ryan DB, Riddlesworth TD, Cefalu WT. Glucose management ındicator (GMI): a new term for estimating A1C from continuous glucose monitoring. Diabetes Care. 2018;41:2275-2280. Epub 2018 Sep 17.
Seget S, Chobot A, Rusak E, Ochab A, Bielawska A, Polanska J, Jarosz-Chobot P. MiniMed 780GTM in children with type 1 diabetes under seven years of age: Prospective open-label, single-arm, double-center, follow-up study. Technol Health Care. 2024;32:1463-1472.
Gomez-Peralta F, Choudhary P, Cosson E, Irace C, Rami-Merhar B, Seibold A. Understanding the clinical implications of differences between glucose management indicator and glycated haemoglobin. Diabetes Obes Metab. 2022;24:599-608. Epub 2022 Feb 8.
MiniMed™ Systems Product Specifications; MiniMed™ 780G System Quick Reference Guide, provided by Medtronic. Available from: https://www.medtronicdiabetes.com/download-library/minimed-780g-system
