美国Jaeb健康研究中心Roy W. Beck团队研究了连续血糖监测对基础胰岛素治疗2型糖尿病患者血糖控制的影响。2021年6月2日，该成果发表在《美国医学会杂志》上。

持续血糖监测（CGM）已被证明对成人2型糖尿病患者使用强化胰岛素治疗是有益的，但其在基础胰岛素治疗而非餐前胰岛素治疗的2型糖尿病患者中的应用尚未明确。

为了在初级保健实践中，确定CGM在成人2型糖尿病患者中应用基础胰岛素而非膳食胰岛素治疗的有效性，2018年7月30日至2019年10月30日，研究组在美国的15个中心进行了一项随机临床试验，招募接受初级保健临床医生糖尿病治疗的2型糖尿病成人，每天注射1或2次长效或中效基础胰岛素（不含餐前胰岛素），同时服用或不服用非胰岛素降糖药物的患者。

将其按2：1随机分配，其中116例接受CGM，59例接受传统血糖仪（BGM）监测。主要结局为8个月时的糖化血红蛋白（HbA1c）水平。关键次要结局为CGM测量的目标血糖范围为70-180 mg/dL的时间、血糖水平高于250 mg/dL的时间以及8个月时的平均血糖水平。

175名参与者的平均年龄为57岁，50%为女性，53%为少数族裔，基线HbA1c水平为9.1%，共有165例（94%）完成了试验。CGM组的平均HbA1c水平从基线时的9.1%降至8个月时的8.0%，BGM组从9.0%降至8.4%，降幅差异显著。CGM组患者70-180 mg/dL目标血糖范围内的平均时间百分比为59%，显著高于BGM组的43%；大于250 mg/dL的平均时间百分比为11%，显著低于BGM组的27%；平均血糖值为179 mg/dL，显著低于BGM组的206 mg/dL。CGM组和BGM组分别有1例（1%）和1例（2%）患者发生严重低血糖事件。

研究结果表明，对于接受基础胰岛素而非餐前胰岛素治疗的2型糖尿病控制不佳的成人，与血糖仪监测相比，连续血糖监测可导致8个月时HbA1c水平显著降低。

附：英文原文

Title: Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial

Author: Thomas Martens, Roy W. Beck, Ryan Bailey, Katrina J. Ruedy, Peter Calhoun, Anne L. Peters, Rodica Pop-Busui, Athena Philis-Tsimikas, Shichun Bao, Guillermo Umpierrez, Georgia Davis, Davida Kruger, Anuj Bhargava, Laura Young, Janet B. McGill, Grazia Aleppo, Quang T. Nguyen, Ian Orozco, William Biggs, K. Jean Lucas, William H. Polonsky, John B. Buse, David Price, Richard M. Bergenstal, MOBILE Study Group, Anders Carlson, Sharon Chambers, Shoua Yang, Marian Sue Kirkman, Alexander Kass, Rachael Fraser, Terra Cushman, Clementina Ramos, Maria Magar, Martha Walker, Sara Serafin-Dokhan, Maamoun Salam, Stacy Hurst, Mary Jane Clifton, Jelena Kravarusic, Anupam Bansal, Candice Fulkerson, Lynn Ang, Caroline Richardson, Kara Mizokami-Stout, Jake Reiss, Virginia Leone, Kirstie Stifel, George Dailey, Amy Change, James McCallum, Maria Isabel Garcia, Dianne Davis, Cynthia Lovell, Connie Root, Freida Toler, Lori Wilhelm, Robin Eifert, Lorena Murguia, Becky Cota, Loida Nguyen, Randie Lipski, Mary Katherine Lawrence, Adelle Fournier, Matthew Carter, Stephanie Hoover, Nathan Cohen, Thomas Mouse, Jessica Rusnak, Tiffany Campos, Nelly Njeru, Tom Arant, Stayce E. Beck, Andrew Balo

Issue&Volume: 2021-06-02

Abstract:

Importance  Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.

Objective  To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.

Design, Setting, and Participants  This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.

Interventions  Random assignment 2:1 to CGM (n=116) or traditional blood glucose meter (BGM) monitoring (n=59).

Main Outcomes and Measures  The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.

Results  Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, 0.4% [95% CI, 0.8% to 0.1%]; P=.02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P<.001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, 16% [95% CI, 21% to 11%]; P<.001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, 26 mg/dL [95% CI, 41 to 12]; P<.001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.

Conclusions and Relevance  Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.

DOI: 10.1001/jama.2021.7444

Source: https://jamanetwork.com/journals/jama/fullarticle/2780593