Abstract
Insulin antibody (IA) 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 this cross-sectional, retrospective case-control study to assess the relationship between IA titer and mean amplitude glycemic excursion (MAGE) in type 2 diabetes mellitus (T2DM) patients using a continuous glucose monitoring (CGM) system. We recruited 100 eligible patients (IA > 5%, IA positive) and divided them into two groups—a low (L) group and a high (H) group—based on their IA titer. The control (C) group consisted of 47 patients (IA ≤ 5%, IA negative) matched for age, BMI, gender, and glycosylated hemoglobin A1c (HbA1c). The CGM determined the GV of enrolled patients. The primary outcome was the relationship between the IA titer and the MAGE, and the secondary outcome was the differences of GV among the three groups. We found that patients in the H group had higher levels of blood glucose fluctuation parameters than those in the L and C groups. The Ln(IA) was positively correlated with Ln(MAGE) even after adjusting for age, gender, BMI, HbA1c, and fasting and postprandial C-peptide(r = 0.423, p < 0.001). Multiple linear stepwise regression analysis revealed that Ln(IA) was an independent factor of Ln(MAGE) (beta = 0.405, p < 0.001). In conclusion, the higher circulating IA titer was associated with increased MAGE in T2DM patients, indicating that those patients with elevated IA titer should receive GV assessment and individualized treatment.
Highlights
Administration of exogenous animal insulin for the treatment of diabetes often induces the production of insulin antibodies (IA) [1, 2]
Inclusion criteria for the IA-positive group (IA titer > 5%) included the following: (1) patient age is ≥18 years, (2) body mass index (BMI) was between 18 and 35 kg/m2, (3) insulin regimen was low premixed human insulin or insulin analogue, (4) the history of usage of premixed human insulin or insulin analogue was longer than one year, (5) IA was negative before human insulin or insulin analogue treatment, (6) there are no changes in the type of insulin and oral antidiabetic drugs from 3 months before the end of index date, (7) oral antidiabetic drugs were metformin (0.5 g, thrice a day) and/or acrobose (50 mg, thrice a day), and (8) the patient had at least 24 h continuous glucose monitoring (CGM) data
100 patients (45 men and 55 women; age 62 90 ± 11 11 years, BMI 24 63 ± 3 22 kg/m2, and hemoglobin A1c (HbA1c) values 8 49 ± 1 45%) were enrolled and subdivided into two groups according to IA titer as follows: a low (L) group with IA titers > 5% and ≤15.53% (50 patients) and a high (H) group with IA titers > 15 53% (50 patients)
Summary
Administration of exogenous animal insulin for the treatment of diabetes often induces the production of insulin antibodies (IA) [1, 2]. The usage of recombinant human insulin preparations and human insulin analogues has significantly reduced but not entirely suppressed the incidence of IA development [3,4,5,6]. These antibodies might affect a patient’s glycemic control due to their tendency to bind and/or release insulin in an unpredictable fashion [7,8,9]. It should be noted that these studies set HbA1c level and hypoglycemia episodes, not glycemic variability (GV), as their primary outcomes
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