The University of Queensland, Diamantina Institute, Translational Research Institute, Brisbane, Queensland, Australia.
Queensland Children's Hospital, Department of Paediatric Endocrinology, Queensland Children's Hospital, South Brisbane, Queensland, Australia.
Pediatr Diabetes. 2019 Mar;20(2):166-171. doi: 10.1111/pedi.12808. Epub 2019 Jan 8.
Stimulated C-peptide measurement after a mixed meal tolerance test (MMTT) is the accepted gold standard for assessing residual beta-cell function in type 1 diabetes (T1D); however, this approach is impractical outside of clinical trials.
To develop an improved estimate of residual beta-cell function in children with T1D using commonly measured clinical variables.
SUBJECTS/METHODS: A clinical model to predict 90-minute MMTT stimulated C-peptide in children with recent-onset T1D was developed from the combined AbATE, START, and TIDAL placebo subjects (n = 46) 6 months post-recruitment using multiple linear regression. This model was then validated in a clinical cohort (Hvidoere study group, n = 262).
A model of estimated C-peptide at 6 months post-diagnosis, which included age, gender, body mass index (BMI), hemoglobin A1c (HbA1c), and insulin dose predicted 90-minute stimulated C-peptide measurements (adjusted R = 0.63, P < 0.0001). The predictive value of insulin dose and HbA1c alone (IDAA1c) for 90-minute stimulated C-peptide was significantly lower (R 0.37, P < 0.0001). The slopes of linear regression lines of the estimated and stimulated 90-minute C-peptide levels obtained at 6 and 12 months post diagnosis in the Hvidoere clinical cohort were R = 0.36, P < 0.0001 at 6 months and R = 0.37, P < 0.0001 at 12 months.
A clinical model including age, gender, BMI, HbA1c, and insulin dose predicts stimulated C-peptide levels in children with recent-onset T1D. Estimated C-peptide is an improved surrogate to monitor residual beta-cell function outside clinical trial settings.
混合餐耐量试验（MMTT）后刺激 C 肽的测量是评估 1 型糖尿病（T1D）患者残余β细胞功能的公认金标准；然而，这种方法在临床试验之外是不切实际的。
使用常用的临床变量在 T1D 儿童中开发一种改进的残余β细胞功能估计方法。
受试者/方法：使用多元线性回归，从 AbATE、START 和 TIDAL 安慰剂受试者（n=46）发病后 6 个月的合并数据中建立了一个用于预测近期发病的 T1D 儿童 90 分钟 MMTT 刺激 C 肽的临床模型。然后在一个临床队列（Hvidoere 研究组，n=262）中进行验证。
一个包括年龄、性别、体重指数（BMI）、糖化血红蛋白（HbA1c）和胰岛素剂量的模型，可预测诊断后 6 个月的估计 C 肽（调整 R = 0.63，P < 0.0001）。单独使用胰岛素剂量和 HbA1c（IDAA1c）预测 90 分钟刺激 C 肽的预测值显著较低（R 0.37，P < 0.0001）。在 Hvidoere 临床队列中，诊断后 6 个月和 12 个月获得的估计和刺激 90 分钟 C 肽水平的线性回归线斜率为 R = 0.36，P < 0.0001，在 6 个月时为 R = 0.37，P < 0.0001。
包括年龄、性别、BMI、HbA1c 和胰岛素剂量的临床模型可预测近期发病的 T1D 患者的刺激 C 肽水平。估计的 C 肽是监测临床试验以外残余β细胞功能的一种改进的替代方法。
