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Advanced Hybrid Closed-Loop Systems in Perioperative Care: Safety During Anesthesia
Ana Maria Gómez1,2, Diana Henao-Carrillo1,2, Oscar Muñoz-Velandia2,3
1Endocrinology Unit, Hospital Universitario San Ignacio, Bogotá, Colombia.
Insights
Advanced hybrid closed-loop (AHCL) systems safely manage blood glucose during surgery, significantly improving time in range and reducing hypoglycemia. Further trials are needed to compare AHCL with standard care.
Area of Science:
- Endocrinology
- Medical Devices
- Surgical Care
Background:
- Limited evidence exists on advanced hybrid closed-loop (AHCL) systems' safety and efficacy in the perioperative period.
- There's a lack of specific management guidelines for AHCL systems during surgical procedures.
Purpose of the Study:
- To evaluate glycemic control metrics in patients using AHCL systems during intraoperative and postoperative phases.
- To assess the safety and feasibility of AHCL systems in surgical patients with diabetes.
Main Methods:
- Prospective cohort study of adult patients with type 1 or type 2 diabetes using the MiniMed™780G AHCL system during surgery.
- Comparison of time in range (TIR), time below range (TBR), time above range (TAR), and time in normoglycemia range (TINR) during perioperative periods versus baseline.
Main Results:
- AHCL systems maintained high time in range (99.6%) and time in normoglycemia (58.6%) during surgery.
- Significant reduction in time below range (<70 mg/dL) to 0% and time above range (>180 mg/dL) to 0.1% was observed.
- No hypoglycemic events (<70 mg/dL or <54 mg/dL) or severe device-related adverse events occurred.
Conclusions:
- Continuing AHCL system insulin infusion is feasible and safe during the perioperative period.
- AHCL systems effectively maintain glycemic control, achieving high TIR and TINR without hypoglycemia.
- Randomized clinical trials are recommended to compare AHCL technology with standard perioperative diabetes management.
Background:
There is limited evidence regarding the safety and efficacy of advanced hybrid closed-loop (AHCL) systems during the perioperative period. Specific management guidelines for these systems are lacking.
Objective:
To describe glycemic control metrics in patients with AHCL system during the intraoperative and postoperative periods.
Methods:
Analytical study based on a prospective cohort of adults with type 1 diabetes (T1D) or type 2 diabetes who are treated with AHCL system (MiniMed™780G, Medtronic, USA) and are undergoing surgical procedures. The study compared time in range (%TIR) between 70 and 180 mg/dL, time below range (%TBR) <70 and <54 mg/dL, time above range (%TAR) >180 and >250 mg/dL, and time in normoglycemia range (%TINR) between 70 and 140 mg/dL during the intraoperative, immediate postoperative, and late postoperative periods, with baseline measurements.
Results:
The analysis included 15 patients (86% T1D; 55.4 ± 16.3 years) and 17 surgical procedures (70% elective; mean duration 65.3 ± 36.3 min). Baseline data obtained 24 h prior to the admission: %TIR 78.4 ± 17.5%, %TINR 58.6 ± 22.9%, and %TBR <70 mg/dL 3.7 ± 4.2%. During the intraoperative period, %TIR increased to 99.6 ± 1.5% (P < 0.001), and %TBR <70 mg/dL decreased to 0 (P < 0.001). %TAR >180 mg/dL decreased from 17.8 ± 16.8% to 0.1 ± 1.5% (P < 0.001). No hypoglycemic events <70 mg/dL or <54 mg/dL were documented in the intraoperative and immediate postoperative periods. No severe adverse events related to device use were recorded.
Conclusions:
During the perioperative period, continuing insulin infusion using AHCL system is feasible, maintaining high levels of %TIR and %TINR, without hypoglycemia or serious adverse events. Randomized clinical trials are needed to compare the use of this technology with usual care.
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