Efficacy and Safety of Hybrid Closed-Loop System in Outpatient Adults with Type 2 Diabetes—A Systematic Review and Meta-analysis


Kodalak S., Ratan P., Andrade A. D., Saldarriaga L., Lauland T. C. G., Trevisan T.

American Diabetes Association 85th Scientific Sessions, Illinois, Amerika Birleşik Devletleri, 21 - 23 Haziran 2025, ss.2013, (Tam Metin Bildiri)

  • Yayın Türü: Bildiri / Tam Metin Bildiri
  • Basıldığı Şehir: Illinois
  • Basıldığı Ülke: Amerika Birleşik Devletleri
  • Sayfa Sayıları: ss.2013
  • Hacettepe Üniversitesi Adresli: Evet

Özet

Introduction and Objective: Hybrid closed-loop systems (HCLS) are the standard of care in the management of type 1 diabetes. However, evidence for HCLS in outpatient type 2 diabetes (T2D) care is still limited. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of HCLS compared to other modalities of therapy in outpatient adults with T2D.

Methods: A systematic search of PubMed, Scopus, Web of Science, Cochrane Library and clinicaltrials.gov identified 6 randomized controlled trials (5 crossover and 1 parallel-design). Four studies compared HCL with multiple daily insulin injections (MDI), 1 with insulin pump, and 1 with oral antidiabetic drugs in outpatients with T2D. Mean difference (MD) with 95% confidence intervals (CIs) were calculated using a random-effects model. Statistical analyses were performed using Review Manager 5.4.1.

Results: Six studies involving a total of 125 participants were included. Participants' ages ranged from 57.2 to 69.5 years, with diabetes duration spanning 7.6 to 24 years. Mean baseline glycated hemoglobin ranged from 7.2% to 9.13%. During the HCLS period, the time in range (TIR; 70-180 mg/dL) was 18.85% higher (95% CI: 8.95 to 28.74; p = 0.0002), equivalent to an extra 4 hours and 31 minutes compared to other treatments. Time above range (TAR; >180mg/dL) was 16.72% lower (95% CI: -25.00 to -8.44; p<0.0001) and time below range (TBR; <70mg/dL) was 0.18% lower (95% CI: -0.34 to -0.01; p = 0.04) in HCLS compared to the control group. There was no significant difference in coefficient of variation (MD -0.31; 95% CI: -2.47 to 1.85; p = 0.78), or total daily insulin dose (MD -8.08; 95% CI: -22.47 to 6.31; p = 0.27). Regarding safety, 2 studies reported 5 hypoglycemia episodes in the HCLS arm.

Conclusion: Hybrid closed-loop systems in outpatient adults with T2D improved glycemic control without safety concerns compared to other treatment options. Further research, including real-world studies with patient-reported outcomes, is needed