A clinical case of the use of a closed loop system in the treatment of type 1 diabetes mellitus

The urgency of the problem of type 1 diabetes mellitus (T1DM) does not lose ground over time due to the peculiarities of the course of the disease, the need for radical lifestyle correction, which leads to a decrease in the quality of life of patients, as well as a high probability of early disability and mortality of patients at a young age. Unsatisfactory glycemic control in T1DM is closely interrelated with both the risk of rapid development of chronic complications and the likelihood of acute complications. Achieving optimal glycemic control during insulin therapy requires frequent monitoring of glycemia, a detailed understanding of the rules for counting bread units, the ability to recognize and stop hypoglycemia at early stages, as well as the ability to adapt the administration of insulin to various life situations. With the advent of pump insulin therapy, some of these factors stopped to cause inconvenience to patients, however, even with pump insulin therapy, patients still need frequent monitoring of glycemia, self-administration of bolus insulin with counting bread units, as well as correction of insulin administration manually if necessary. The use of a closed loop system is highly promising in terms of improving the quality of life of patients with T1DM. This project is a semblance of a healthy pancreas. The goal is to maintain normoglycemia or blood glucose levels in a set range by automatically adjusting the basal and bolus insulin secretion rates using a pump. The adjustment of insulin secretion by the pump is carried out in accordance with the indications of the continuous glucose monitoring system. We present a clinical case of using this system by a patient with T1DM.

1. Bergenstal R.M., Tamborlane W.V., Ahmann A., Buse J.B., Dailey G., Davis S.N., et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010; 363: 311–20. doi: 10.1056/NEJMoa1002853

2. Volkova AR, Chernaya ME, Lisker AV et al. Variability of glycemia in patients with type 1 diabetes mellitus on different types of insulin therapy. Endocrinology: news, opinions, training 2019;8(3):38-43 (In Russ.) doi: 10.24411/2304–9529–2019– 13004

3. Ware J, Boughton CK, Allen JM, Wilinska ME, Tauschmann M, Denvir L, Thankamony A, Campbell FM, Wadwa RP, Buckingham BA, Davis N, DiMeglio LA, Mauras N, Besser REJ, Ghatak A, Weinzimer SA, Hood KK, Fox DS, Kanapka L, Kollman C, Sibayan J, Beck RW, Hovorka R; DAN05 Consortium. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial. Lancet Digit Health. 2022 Apr;4(4):e245-e255. doi: 10.1016/S2589-7500(22)00020-6

4. Saunders A, Messer LH, Forlenza GP. MiniMed 670G hybrid closed loop artificial pancreas system for the treatment of type 1 diabetes mellitus: overview of its safety and efficacy. Expert Rev Med Devices. 2019 Oct;16(10):845-853. doi: 10.1080/17434440.2019.1670639

5. Volkova A.R., Chernaya M.E., Lisker A.V., Vlasova K.A. Analysis of the experience of using insulin therapy with the closed loop method among patients with type 1 diabetes in Russia. Endokrinologiya: novosti, mneniya, obuchenie [Endocrinology: News, Opinions, Training]. 2020; 9 (1): 35–41. doi: 10.33029/2304-9529-2020-9-1-35-41 (in Russian)

6. Kadish AH. Automation Control of Blood Sugar a Servomechanism for Glucose Monitoring and Control. Trans Am Soc Artif Intern Organs (1963) 9:363–67

7. Fogt EJ, Dodd LM, Jenning EM, Clemens AH. Development and Evaluation of a Glucose Analyzer for a Glucose Controlled Insulin Infusion System (Biostator). Clin Chem (1978) 24:1366–72. doi: 10.1093/clinchem/24.8.1366

8. Shichiri M, Kawamori R, Hakui N, Yamasaki Y, Abe H. Closed-Loop Glycemic Control With a Wearable Artificial Endocrine Pancreas. Variations in Daily Insulin Requirements to Glycemic Response. Diabetes (1984) 33:1200–02. doi: 10.2337/diab.33.12.1200

9. Russell S.J., El-Khatib F.H., Sinha M., Magyar K.L., McKeon K., Goergen L.G. et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes // N. Engl. J. Med. 2014. Vol. 371. P. 313–325. doi: 10.1056/NEJMoa1314474Allen N., Gupta A. Current diabetes technology: striving for the Artificial pancreas // BMJ Open. 2019. Vol. 9, N 6. P. e027856. doi: 10.1136/bmjopen-2018–027856.

10. FDA News Release 12-20-2016: FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decision. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534056.htm

11. Bergenstal RM, Beck RW, Close KL, et al. Glucose management indicator (GMI): a new term for estimating A1C from continuous glucose monitoring. Diabetes Care. 2018;41:2275–2280. doi: 10.2337/dc18-1581

12. Bekiari E., Kitsios K., Thabit H., et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ. 2018; 361. doi: https://doi.org/10.1136/bmj.k1310

13. Brown S.A., Kovatchev B.P., Raghinaru D. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes // N. Engl. J. Med. 2019. Vol. 381. P. 1707–1717. doi: 10.1056/NEJMoa1907863