Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study.

IF 14.8 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Care Pub Date : 2023-11-01 DOI:10.2337/dc23-0728

Charlotte K Boughton, Sara Hartnell, Rama Lakshman, Munachiso Nwokolo, Malgorzata E Wilinska, Julia Ware, Janet M Allen, Mark L Evans, Roman Hovorka

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Abstract

Objective: We evaluated the safety and efficacy of fully closed-loop with ultrarapid insulin lispro in adults with type 1 diabetes and suboptimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM).

Research design and methods: This single-center, randomized, crossover study enrolled 26 adults with type 1 diabetes using insulin pump therapy with suboptimal glycemic control (mean ± SD, age 41 ± 12 years, HbA1c 9.2 ± 1.1% [77 ± 12 mmol/mol]). Participants underwent two 8-week periods of unrestricted living to compare fully closed-loop with ultrarapid insulin lispro (CamAPS HX system) with insulin pump therapy with CGM in random order.

Results: In an intention-to-treat analysis, the proportion of time glucose was in range (primary end point 3.9-10.0 mmol/L) was higher during closed-loop than during pump with CGM (mean ± SD 50.0 ± 9.6% vs. 36.2 ± 12.2%, mean difference 13.2 percentage points [95% CI 9.5, 16.9], P < 0.001). Time with glucose >10.0 mmol/L and mean glucose were lower during closed-loop than during pump with CGM (mean ± SD time >10.0 mmol/L: 49.0 ± 9.9 vs. 62.9 ± 12.6%, mean difference -13.3 percentage points [95% CI -17.2, -9.5], P < 0.001; mean ± SD glucose 10.7 ± 1.1 vs. 12.0 ± 1.6 mmol/L, mean difference -1.2 mmol/L [95% CI -1.8, -0.7], P < 0.001). The proportion of time with glucose <3.9 mmol/L was similar between periods (median [interquartile range (IQR)] closed-loop 0.88% [0.51-1.55] vs. pump with CGM 0.64% [0.28-1.10], P = 0.102). Total daily insulin requirements did not differ (median [IQR] closed-loop 51.9 units/day [35.7-91.2] vs. pump with CGM 50.7 units/day [34.0-70.0], P = 0.704). No severe hypoglycemia or ketoacidosis occurred.

Conclusions: Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control.

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全闭环血糖控制与胰岛素泵治疗在成人1型糖尿病和次优血糖控制中的比较：一项单中心、随机、交叉研究。

目的：与连续血糖监测（CGM）的胰岛素泵治疗相比，我们评估了完全闭环超快速利斯普胰岛素治疗成人1型糖尿病和次优血糖控制的安全性和有效性，交叉研究纳入了26名1型糖尿病成年人，他们使用胰岛素泵治疗，血糖控制不理想（平均值±SD，年龄41±12岁，糖化血红蛋白9.2±1.1%[77±12 mmol/mol]）。参与者接受了两次为期8周的无限制生活，以随机顺序比较完全闭环的超快速利斯普胰岛素（CamAPS HX系统）和CGM胰岛素泵治疗。结果：在意向治疗分析中，葡萄糖在范围内的时间比例（主要终点3.9-10.0 mmol/L）在闭环期间高于CGM泵送期间（平均±SD 50.0±9.6%与36.2±12.2%，平均差异13.2个百分点[95%CI 9.5，16.9]，P<0.001）。葡萄糖>1.0 mmol/L的时间和平均葡萄糖在闭环期间低于CGM泵运期间（平均±SD时间>10.0 mmol/L：49.0±9.9 vs.62.9±12.6%，平均差异-13.3个百分点[95%CI-17.2，-9.5]，P<0.001；平均±SD葡萄糖10.7±1.1 vs.12.0±1.6 mmol/L，平均差异-1.2 mmol/L[95%CI-1.8，-0.7]，P<0.001）。与葡萄糖相关的时间比例结论：与胰岛素相比，CamAPS HX全闭环胰岛素递送改善了葡萄糖控制CGM对患有1型糖尿病和血糖控制不理想的成年人的泵送治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes Care 医学-内分泌学与代谢

CiteScore

27.80

自引率

4.90%

发文量

449

审稿时长

1 months

期刊介绍： The journal's overarching mission can be captured by the simple word "Care," reflecting its commitment to enhancing patient well-being. Diabetes Care aims to support better patient care by addressing the comprehensive needs of healthcare professionals dedicated to managing diabetes. Diabetes Care serves as a valuable resource for healthcare practitioners, aiming to advance knowledge, foster research, and improve diabetes management. The journal publishes original research across various categories, including Clinical Care, Education, Nutrition, Psychosocial Research, Epidemiology, Health Services Research, Emerging Treatments and Technologies, Pathophysiology, Complications, and Cardiovascular and Metabolic Risk. Additionally, Diabetes Care features ADA statements, consensus reports, review articles, letters to the editor, and health/medical news, appealing to a diverse audience of physicians, researchers, psychologists, educators, and other healthcare professionals.