A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes.

Diabetes care Pub Date : 2024-12-06 DOI:10.2337/dc24-1832

Irl B Hirsch, Roy W Beck, Martin C Marak, Yogish Kudva, Halis K Akturk, Anuj Bhargava, Kevin Codorniz, Jamie Diner, Grazia Aleppo, Thomas Blevins, Carol J Levy, Philip Raskin, Kristin Castorino, Anastasios Manessis, David Pickering, Devin W Steenkamp, Ruth S Weinstock, Bruce W Bode, Osama Hamdy, Quang T Nguyen, Mark Kipnes, Katrina J Ruedy, Donna Desjardins, Zehra Haider, Christopher Jacobson, Scott Lee, John B Buse, Klara Rachel Klein, Grenye O'Malley, Mei Mei Church, Adham Mottalib, Jesica D Baran, Corey Kurek, Shafaq Rizvi, Cassandra Donahue, Denisa Tamarez, Astrid Atakov Castillo, Sarah Borgman, Sarah Frey, Peter Calhoun

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引用次数: 0

Abstract

Objective: To evaluate a regimen of inhaled Technosphere insulin (TI) plus insulin degludec in adults with type 1 diabetes, who prestudy were predominately using either an automated insulin delivery (AID) system or multiple daily insulin injections (MDI) with continuous glucose monitoring.

Research design and methods: At 19 sites, adults with type 1 diabetes were randomly assigned to TI plus insulin degludec (N = 62) or usual care (UC) with continuation of prestudy insulin delivery method (N = 61) for 17 weeks.

Results: Prestudy, AID was used by 48% and MDI by 45%. Mean ± SD HbA1c was 7.57% ± 0.97% at baseline and 7.62% ± 1.06% at 17 weeks in the TI group and 7.59% ± 0.80% and 7.54% ± 0.77%, respectively, in the UC group (adjusted difference 0.11%, 95% CI -0.10 to 0.33, P value for noninferiority = 0.01). HbA1c improved from baseline to 17 weeks by >0.5% (5.5 mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by >0.5% (5.5 mmol/mol) in 15 (26%) in the TI group and in 2 (3%) in the UC group. The most common TI side effect was a brief cough; eight participants discontinued TI due to side effects.

Conclusions: In adults with type 1 diabetes, HbA1c after 17 weeks with a regimen of TI and degludec was noninferior to UC, which consisted predominately of either AID or MDI. TI should be considered an option for people with type 1 diabetes, particularly those who are motivated to further reduce postprandial hyperglycemia.

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一项比较吸入胰岛素加基础胰岛素与常规治疗成人1型糖尿病的随机试验。

目的：评价吸入Technosphere胰岛素（TI）加degludec胰岛素治疗成人1型糖尿病患者的方案，这些患者在研究前主要使用自动胰岛素输送（AID）系统或多次每日胰岛素注射（MDI）并持续血糖监测。研究设计和方法：在19个地点，1型糖尿病成人患者被随机分配到TI + degludec胰岛素组（N = 62）或常规护理组（UC），并继续研究前胰岛素输送方法（N = 61），为期17周。结果：研究前，AID使用率为48%，MDI使用率为45%。TI组基线时HbA1c均值±SD为7.57%±0.97%，17周时为7.62%±1.06%，UC组分别为7.59%±0.80%和7.54%±0.77%（校正差为0.11%，95% CI为-0.10 ~ 0.33，P值为非逊色性= 0.01）。从基线到17周，TI组12例（21%）和UC组3例（5%）的HbA1c改善了>0.5% (5.5 mmol/mol)， TI组15例（26%）和UC组2例（3%）的HbA1c恶化了>0.5% （5.5 mmol/mol）。TI最常见的副作用是短暂的咳嗽；8名参与者因副作用停止使用TI。结论：在成人1型糖尿病患者中，TI和degludec治疗17周后的HbA1c不低于UC， UC主要由AID或MDI组成。对于1型糖尿病患者，尤其是那些有动机进一步降低餐后高血糖的患者，TI应被视为一种选择。

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

CiteScore

29.50

自引率

0.00%

发文量