Secher Anna Lilja, Pedersen-Bjergaard Ulrik, Svendsen Ole L, Gade-Rasmussen Birthe, Almdal Thomas, Raimond Linda, Vistisen Dorte, Nørgaard Kirsten
Steno Diabetes Center Copenhagen, Gentofte, Denmark.
Department of Endocrinology & Nephrology, Nordsjællands Hospital, Hillerød, Denmark.
Diabetologia. 2021 Dec;64(12):2713-2724. doi: 10.1007/s00125-021-05555-8. Epub 2021 Sep 8.
AIMS/HYPOTHESIS: We aimed to compare the effects of intermittently scanned continuous glucose monitoring (isCGM) and carbohydrate counting with automated bolus calculation (ABC) with usual care.
In a randomised, controlled, open-label trial carried out at five diabetes clinics in the Capital Region of Denmark, 170 adults with type 1 diabetes for ≥1 year, multiple daily insulin injections and HbA > 53 mmol/mol (7.0%) were randomly assigned 1:1:1:1 with centrally prepared envelopes to usual care (n = 42), ABC (n = 41), isCGM (n = 48) or ABC+isCGM (n = 39). Blinded continuous glucose monitoring data, HbA and patient-reported outcomes were recorded at baseline and after 26 weeks. The primary outcome was change in time in range using isCGM vs usual care.
Baseline characteristics were comparable across arms: mean age 47 (SD 13.7) years, median (IQR) diabetes duration 18 (10-28) years and HbA 65 (61-72) mmol/mol (8.1% [7.7-8.7%]). Change in time in range using isCGM was comparable to usual care (% difference of 3.9 [-12-23], p = 0.660). The same was true for the ABC and ABC+isCGM arms and for hypo- and hyperglycaemia. Also compared with usual care, using ABC+isCGM reduced HbA (4 [95% CI 1, 8] mmol/mol) (0.4 [0.1, 0.7] %-point) and glucose CV (11% [4%, 17%]) and improved treatment satisfaction, psychosocial self-efficacy and present life quality. Treatment satisfaction also improved by using isCGM alone vs usual care. Statistical significance was maintained after multiple testing adjustment concerning glucose CV and treatment satisfaction with ABC+isCGM, and treatment satisfaction with isCGM. Discontinuation was most common among ABC only users, and among completers the ABC was used 4 (2-5) times/day and the number of daily isCGM scans was 5 (1-7) at study end.
CONCLUSIONS/INTERPRETATION: isCGM alone did not improve time in range, but treatment satisfaction increased in technology-naive people with type 1 diabetes and suboptimal HbA. The combination of ABC+isCGM appears advantageous regarding glycaemic variables and patient-reported outcomes, but many showed resistance towards ABC.
ClinicalTrials.gov NCT03682237.
The study is investigator initiated and financed by the Capital Region of Denmark.
目的/假设：我们旨在比较间歇性扫描式动态血糖监测（isCGM）以及碳水化合物计数结合自动 bolus 计算（ABC）与常规护理的效果。
在丹麦首都地区五家糖尿病诊所进行的一项随机、对照、开放标签试验中，170 名患有 1 型糖尿病≥1 年、每日多次注射胰岛素且糖化血红蛋白>53 mmol/mol（7.0%）的成年人，通过中央准备的信封以 1:1:1:1 的比例随机分配至常规护理组（n = 42）、ABC 组（n = 41）、isCGM 组（n = 48）或 ABC + isCGM 组（n = 39）。在基线和 26 周后记录盲态的动态血糖监测数据、糖化血红蛋白及患者报告的结局。主要结局是使用 isCGM 与常规护理相比在血糖目标范围内时间的变化。
各治疗组的基线特征具有可比性：平均年龄 47（标准差 13.7）岁，糖尿病病程中位数（四分位间距）为 18（10 - 28）年，糖化血红蛋白为 65（61 - 72）mmol/mol（8.1% [7.7 - 8.7%]）。使用 isCGM 时血糖目标范围内时间的变化与常规护理相当（差异百分比为 3.9 [-12 - 23]，p = 0.660）。ABC 组和 ABC + isCGM 组在低血糖和高血糖方面以及与常规护理相比情况相同。同样与常规护理相比，使用 ABC + isCGM 可降低糖化血红蛋白（4 [95%置信区间 1, 8] mmol/mol）（0.4 [0.1, 0.7] 百分点）和血糖变异系数（11% [4%, 17%]），并改善治疗满意度、心理社会自我效能感和当前生活质量。单独使用 isCGM 与常规护理相比，治疗满意度也有所提高。在对血糖变异系数和 ABC + isCGM 的治疗满意度以及 isCGM 的治疗满意度进行多重检验调整后，仍保持统计学显著性。停药在仅使用 ABC 的患者中最为常见，在完成治疗的患者中，研究结束时 ABC 每天使用 4（2 - 5）次，isCGM 每日扫描次数为 5（1 - 7）次。
结论/解读：单独使用 isCGM 并未改善血糖目标范围内时间，但在 1 型糖尿病且糖化血红蛋白未达最佳水平的初用技术者中治疗满意度有所提高。ABC + isCGM 联合使用在血糖变量和患者报告结局方面似乎具有优势，但许多人对 ABC 存在抵触。
ClinicalTrials.gov NCT03682237。
本研究由研究者发起，由丹麦首都地区提供资金。
