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在真实世界环境中,使用基础胰岛素治疗 2 型糖尿病的糖尿病未满足需求评估(DUNE)研究:实现 HbA1c 目标。

The Diabetes Unmet Need with Basal Insulin Evaluation (DUNE) study in type 2 diabetes: Achieving HbA1c targets with basal insulin in a real-world setting.

机构信息

Division of Endocrinology, University of Texas Southwestern Medical Center, Dallas, Texas.

Global Diabetes Program, Parkland Health & Hospital System, Dallas, Texas.

出版信息

Diabetes Obes Metab. 2019 Jun;21(6):1429-1436. doi: 10.1111/dom.13673. Epub 2019 Mar 28.

Abstract

AIMS

To describe in a real-world setting the achievement of physician-selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement.

MATERIALS AND METHODS

A 12-week, prospective, single-arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP-1 receptor agonists.

RESULTS

Individualized targets for almost all of the 3139 evaluable participants (99.7%) had been set by their physicians, with 57% of participants having HbA1c targets between 7.0% and <7.5% (53 and <58 mmol/mol). By week 12, 28% and 27% of newly and previously initiated participants, respectively, achieved individualized HbA1c targets with modest average increases in daily insulin dose of 9 and 5 U (0.10 and 0.06 U/kg), respectively, from baseline (14 and 23 U [0.17 and 0.29 U/kg], respectively). Overall, 16% of participants experienced at least one episode of hypoglycaemia. Both the incidence and frequency of hypoglycaemia, but not the severity, were positively associated with a higher likelihood of achieving individualized HbA1c targets (P < 0.05).

CONCLUSIONS

In this prospective real-world study, most participants using basal insulin did not achieve the individualized HbA1c targets set by their physicians. Participants who experienced symptomatic hypoglycaemia were more likely to achieve HbA1c targets than those who did not.

摘要

目的

在新诊断或近期起始基础胰岛素治疗的 2 型糖尿病患者的真实世界环境中描述医生选择的个体化糖化血红蛋白(HbA1c)目标的达成情况,以及低血糖与目标达成的相关性。

材料和方法

这是一项为期 12 周的前瞻性、单臂、观察性研究,纳入了新诊断或近期起始基础胰岛素治疗的成年 2 型糖尿病患者。入组时,来自 28 个国家的合格参与者正在接受或未接受口服降糖药和/或 GLP-1 受体激动剂治疗。

结果

3139 例可评估参与者中的几乎所有人(99.7%)的个体化目标均由医生设定,其中 57%的参与者的 HbA1c 目标为 7.0%<7.5%(53<58mmol/mol)。治疗 12 周后,分别有 28%和 27%的新诊断和既往起始参与者达到了个体化 HbA1c 目标,平均日胰岛素剂量分别增加了 9 和 5U(分别为 0.10 和 0.06U/kg),而基线时的胰岛素剂量分别为 14 和 23U(分别为 0.17 和 0.29U/kg)。总体而言,16%的参与者至少发生了一次低血糖事件。低血糖的发生率和频率与实现个体化 HbA1c 目标的可能性呈正相关,但严重程度与实现个体化 HbA1c 目标的可能性无关(P<0.05)。

结论

在这项前瞻性真实世界研究中,使用基础胰岛素的大多数参与者未达到医生设定的个体化 HbA1c 目标。与未发生低血糖的参与者相比,发生症状性低血糖的参与者更有可能达到 HbA1c 目标。

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