| Part Ⅰ Higher Insulin Antibody is Associated with Increased Glycemic Variability in Patients with Type 2 DiabetesObjective: Insulin antibody(IA)induced by exogenous insulin may potentially affect a patient’s glycemic control due to its variability in both binding and/or releasing insulin.However,the association between IA titer and daily glycemic variability(GV)is still unknown.We thus performed a study to assess the relationship between IA titer and glycemic variability in patients with type 2 diabetes(T2D)using continuous glucose monitoring(CGM).Methods: We recruited 159 eligible patients consisted of 112 patients with IA positive(IA > 5%)and 47 patient with IA negative(IA ≤ 5%)in this study.All patients were subjected to 72-hrs CGM during the study.The CGM data from Day 1 7:00 to Day 2 7:00 were recorded to calculate the 24-hrs mean blood glucose(MBG),the large amplitude of glycemic excursion(LAGE),the 24-hrs mean amplitude of glycemic excursion(MAGE),the 24-hrs standard deviation of blood glucose(SDBG),the area under curve(AUC)of plasma glucose > 13.9 mmol/L and < 3.9 mmol/L,and the percentage of time in plasma glucose > 13.9 mmol/L and plasma glucose < 3.9 mmol/L.We used the radioimmune assay(RIA)to measure the IA titer of patients.The primary outcome was the relationship between the IA titer and the MAGE.The secondary outcomes were the differences of other glycemic profiles among the three groups.Results: Data from a total of 147 patients were analyzed,and 100 patients with IA positive were divided into low(L)group and high(H)group according to IA titer,the control group(C)consisted of 47 patient with IA negative.The three groups had no difference in age,body mass index(BMI),gender,and glycosylated hemoglobin A1c(Hb A1c)(p > 0.05).We found that patients in the H group had higher levels of blood glucose glycemic parameters than those in the L and C groups [Ln(MAGE): 1.79 ± 0.50(H)vs.1.60 ± 0.35(L)mmol/L;1.79 ± 0.50(H)vs.1.36 ± 0.37(C)mmol/L;p < 0.05,respectively];and patients in the L group had higher levels of blood glucose glycemic parameters than those in the C group [Ln(MAGE): 1.60 ± 0.35(L)vs.1.36 ± 0.37(C)mmol/L;p < 0.05].The Ln(IA)was positively correlated with Ln(MAGE)even after adjusting for BMI,Hb A1 c,fasting and 120-min postprandial C-peptide(r = 0.417,p < 0.05).Multiple linear stepwise regression analysis revealed that Ln(IA)was independent factor of Ln(MAGE)(β = 0.395,p < 0.05).Conclusion: The higher circulating IA titer was associated with increased MAGE in patients with T2 D,indicating those patients with elevated IA titer should receive GV assessment and individualized treatment.Part Ⅱ Insulin Injection Technique is Associated with Glycemic Variability in Patients with Type 2 DiabetesObjective: Many factors can affect glycemic control of patients with type 2 diabetes(T2D)receiving premixed insulin treatment.Insulin injection technique may affect the patients’ glycemic variability(GV).We thus conducted a study to assess the relationship between glycemic variability and insulin injection technique(IT)in patients with T2 D.Methods: This was a single center,cross-sectional,and self-controlled trial.A total of 60 patients with T2 D receiving premixed insulin were enrolled.The study including a 2-day patient insulin injection period(Day 0 and Day 1),and a 2-day specialist nurse insulin injection period(Day 2 and Day 3).Patient’ insulin IT scores were assessed by two independent nurses using a skill-related scale on day 1.All patients were subjected to 96-hrs continuous glucose monitoring(CGM)during the 4-day study.The CGM data from Day 1 7:00 to Day 2 7:00 and Day 3 7:00 to Day 4 7:00 were recorded to calculate the 24-hrs mean blood glucose(MBG),the 24-hrs mean amplitude of glycemic excursion(MAGE),the 24-hrs standard deviation of blood glucose(SDBG),the area under curve(AUC)of plasma glucose > 10.0 mmol/L and < 3.9 mmol/L,and the percentage of time(PT)in hyper-,normo-and hypoglycemia.The primary outcome was the relationship between the insulin IT and glycemic variability during patient injection period.The secondary outcomes were the differences in glycemic profiles delivered by patient and nurse injection.Results: Data from a total of 52 participants were analyzed.The patients’glycosylated hemoglobin A1c(Hb A1c)was 8.08 ± 1.52%,and the insulin IT average score was 16.97 ± 4.36.The patients were divided into high(H)group and low(L)group according to the patients’ IT score.The MAGE during patient injection period in H group was lower than that in L group [Ln(MAGE)1.49 ± 0.51 vs.1.85 ± 0.53 mmol/L,p < 0.05].Multiple linear stepwise regression analysis showed that the patient’s IT score was independent factor of Ln(MAGE)and SDBG during patient injection period(β =-0.327,-0.280;p < 0.05,respectively).We further identified that IT score was also independent factor of Hb A1c(β =-0.350,p < 0.05).Our CGM data showed that the glucose profiles,such as MAGE,SDBG,MBG,AUC > 10 mmol/L and PT in hyperglycemia during patient injection period were significantly higher than those during nurse injection period [5.40(3.72,7.86)vs.3.77(2.78,5.38)mmol/L;2.25 ± 0.97 vs.1.96 ± 0.93 mmol/L;9.53 ± 2.15 vs.8.28 ± 1.93 mmol/L;0.67(0.11,1.70)vs.0.13(0.02,0.97)mmol/L;30.73(9.81,53.82)vs.13.72(2.26,37.07)%;p< 0.05,respectively].The PT in normoglycemia during patient injection period was significantly lower than that during nurse injection period [69.27(46.18,88.19)vs.86.11(61.46,95.05)%,p < 0.05].The AUC < 3.9 mmol/L and PT in hypoglycemia had no difference between the two injection periods(p > 0.05).Conclusions: The lower premixed insulin IT in patients with T2 D may play a important role in the increased glycemic variability.Our data indicated that insulin IT was important for short-and long-run glycemic control. |
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