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接受多次胰岛素注射的 2 型糖尿病患者中,连续血糖监测与常规护理的比较:一项随机试验。

Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial.

机构信息

From Jaeb Center for Health Research, Tampa, Florida; Oregon Health & Science University, Portland, Oregon; Diabetes & Glandular Disease Clinic, San Antonio, Texas; Henry Ford Medical Center, Detroit, Michigan; Washington University in St. Louis, St. Louis, Missouri; Behavioral Diabetes Institute and Dexcom, San Diego, California; Research Institute of Dallas, Dallas, Texas; LMC Diabetes & Endocrinology, Toronto, Ontario, Canada; Joslin Diabetes Center, Boston, Massachusetts; and Park Nicollet International Diabetes Center, St. Louis Park, Minnesota.

出版信息

Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.

Abstract

BACKGROUND

Continuous glucose monitoring (CGM), which studies have shown is beneficial for adults with type 1 diabetes, has not been well-evaluated in those with type 2 diabetes receiving insulin.

OBJECTIVE

To determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin.

DESIGN

Randomized clinical trial. (The protocol also included a type 1 diabetes cohort in a parallel trial and subsequent second trial.) (ClinicalTrials.gov: NCT02282397).

SETTING

25 endocrinology practices in North America.

PATIENTS

158 adults who had had type 2 diabetes for a median of 17 years (interquartile range, 11 to 23 years). Participants were aged 35 to 79 years (mean, 60 years [SD, 10]), were receiving multiple daily injections of insulin, and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9% (mean, 8.5%).

INTERVENTION

Random assignment to CGM (n = 79) or usual care (control group, n = 79).

MEASUREMENTS

The primary outcome was HbA1c reduction at 24 weeks.

RESULTS

Mean HbA1c levels decreased to 7.7% in the CGM group and 8.0% in the control group at 24 weeks (adjusted difference in mean change, -0.3% [95% CI, -0.5% to 0.0%]; P = 0.022). The groups did not differ meaningfully in CGM-measured hypoglycemia or quality-of-life outcomes. The CGM group averaged 6.7 days (SD, 0.9) of CGM use per week.

LIMITATION

6-month follow-up.

CONCLUSION

A high percentage of adults who received multiple daily insulin injections for type 2 diabetes used CGM on a daily or near-daily basis for 24 weeks and had improved glycemic control. Because few insulin-treated patients with type 2 diabetes currently use CGM, these results support an additional management method that may benefit these patients.

PRIMARY FUNDING SOURCE

Dexcom.

摘要

背景

研究表明,连续血糖监测(CGM)有益于 1 型糖尿病患者,但尚未在接受胰岛素多次皮下注射的 2 型糖尿病患者中得到充分评估。

目的

评估 CGM 在接受多次胰岛素皮下注射的 2 型糖尿病成人中的有效性。

设计

随机临床试验。(该方案还包括一项平行试验中的 1 型糖尿病队列和后续的第二次试验。)(ClinicalTrials.gov:NCT02282397)。

地点

北美 25 个内分泌科诊所。

患者

158 名患有 2 型糖尿病的成年人,中位患病时间为 17 年(四分位间距,11 至 23 年)。参与者年龄为 35 至 79 岁(平均 60 岁[标准差,10]),正在接受多次胰岛素皮下注射,糖化血红蛋白(HbA1c)水平为 7.5%至 9.9%(平均 8.5%)。

干预

随机分配至 CGM(n=79)或常规护理(对照组,n=79)。

测量

主要结局为 24 周时 HbA1c 的降低。

结果

CGM 组的平均 HbA1c 水平从 24 周时的 7.7%降至 7.0%,对照组则从 8.0%降至 8.0%(平均变化的调整差异,-0.3%[95%置信区间,-0.5%至 0.0%];P=0.022)。两组在 CGM 测量的低血糖或生活质量结果方面无显著差异。CGM 组平均每周有 6.7 天(标准差,0.9)使用 CGM。

局限性

6 个月随访。

结论

接受多次胰岛素皮下注射的 2 型糖尿病患者中,有很大比例的患者在 24 周内每天或接近每天使用 CGM,血糖控制得到改善。由于目前接受胰岛素治疗的 2 型糖尿病患者中很少使用 CGM,这些结果支持使用一种额外的管理方法,可能使这些患者受益。

主要资金来源

德康。

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