英国剑桥阿登布鲁克医院Roman Hovorka团队研究了1型糖尿病患者接受闭环治疗对C肽分泌的影响。该项研究成果发表在2022年9月7日出版的《新英格兰医学杂志》上。

在新发1型糖尿病患者中，与标准胰岛素治疗相比，混合闭环治疗改善血糖控制是否能保持C肽分泌尚不清楚。

在一项多中心、开放标签、平行组、随机试验中，研究组将10.0-16.9岁的青少年在诊断为1型糖尿病后21天内分别接受混合闭环治疗或标准胰岛素治疗（对照）24个月。主要终点是确诊后12个月血浆C肽水平（混合膳食耐受性试验后）的曲线下面积（AUC）。基于意向治疗人群进行分析。

共有97名参与者（平均年龄为12±2岁）接受随机分组：51人接受闭环治疗，46人接受对照治疗。12个月时C肽水平的AUC（主要终点）在两组之间没有显著差异（闭环治疗组的几何平均值为0.35 pmol/ml，对照治疗组为0.46 pmol/mL）。

24个月时C肽水平的AUC在两组间差异亦不显著（闭环治疗组的几何平均值为0.18 pmol/ml，对照治疗组为0.24 pmol/mL）。12个月时，闭环治疗组的算术平均糖化血红蛋白水平比对照组低4 mmol/mol（0.4个百分点），24个月时低11 mmol/mol（1.0个百分点）。闭环治疗组（3名参与者）共发生5起严重低血糖事件，对照治疗组发生1例；闭环治疗组还发生1例糖尿病酮症酸中毒。

研究结果表明，在新发1型糖尿病的年轻人中，24个月的强化血糖控制似乎不能阻止残留C肽分泌的下降。

附：英文原文

Title: Closed-Loop Therapy and Preservation of C-Peptide Secretion in Type 1 Diabetes

Author: Charlotte K. Boughton, Ph.D.,, Janet M. Allen, R.N.,, Julia Ware, M.D.,, Malgorzata E. Wilinska, Ph.D.,, Sara Hartnell, B.Sc.,, Ajay Thankamony, M.Phil.,, Tabitha Randell, M.D.,, Atrayee Ghatak, M.D.,, Rachel E.J. Besser, Ph.D.,, Daniela Elleri, Ph.D.,, Nicola Trevelyan, M.D.,, Fiona M. Campbell, M.D.,, Judy Sibayan, M.P.H.,, Peter Calhoun, Ph.D.,, Ryan Bailey, M.S.,, Gareth Dunseath, Ph.D.,, and Roman Hovorka, Ph.D.

Issue&Volume: 2022-09-07

Abstract:

Background

Whether improved glucose control with hybrid closed-loop therapy can preserve C-peptide secretion as compared with standard insulin therapy in persons with new-onset type 1 diabetes is unclear.

Methods

In a multicenter, open-label, parallel-group, randomized trial, we assigned youths 10.0 to 16.9 years of age within 21 days after a diagnosis of type 1 diabetes to receive hybrid closed-loop therapy or standard insulin therapy (control) for 24 months. The primary end point was the area under the curve (AUC) for the plasma C-peptide level (after a mixed-meal tolerance test) at 12 months after diagnosis. The analysis was performed on an intention-to-treat basis.

Results

A total of 97 participants (mean [±SD] age, 12±2 years) underwent randomization: 51 were assigned to receive closed-loop therapy and 46 to receive control therapy. The AUC for the C-peptide level at 12 months (primary end point) did not differ significantly between the two groups (geometric mean, 0.35 pmol per milliliter [interquartile range, 0.16 to 0.49] with closed-loop therapy and 0.46 pmol per milliliter [interquartile range, 0.22 to 0.69] with control therapy; mean adjusted difference, 0.06 pmol per milliliter [95% confidence interval {CI}, 0.14 to 0.03]). There was not a substantial between-group difference in the AUC for the C-peptide level at 24 months (geometric mean, 0.18 pmol per milliliter [interquartile range, 0.06 to 0.22] with closed-loop therapy and 0.24 pmol per milliliter [interquartile range, 0.05 to 0.30] with control therapy; mean adjusted difference, 0.04 pmol per milliliter [95% CI, 0.14 to 0.06]). The arithmetic mean glycated hemoglobin level was lower in the closed-loop group than in the control group by 4 mmol per mole (0.4 percentage points; 95% CI, 0 to 8 mmol per mole [0.0 to 0.7 percentage points]) at 12 months and by 11 mmol per mole (1.0 percentage points; 95% CI, 7 to 15 mmol per mole [0.5 to 1.5 percentage points]) at 24 months. Five cases of severe hypoglycemia occurred in the closed-loop group (in 3 participants), and one occurred in the control group; one case of diabetic ketoacidosis occurred in the closed-loop group.

Conclusions

In youths with new-onset type 1 diabetes, intensive glucose control for 24 months did not appear to prevent the decline in residual C-peptide secretion.

DOI: 10.1056/NEJMoa2203496

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2203496