Te Huataki Waiora, School of Health, University of Waikato, Hamilton, New Zealand.
Waikato Regional Diabetes Service, Te Whatu Ora Health New Zealand Waikato, Hamilton, New Zealand.
Diabet Med. 2024 Aug;41(8):e15348. doi: 10.1111/dme.15348. Epub 2024 May 17.
To investigate the impact of real-time continuous glucose monitoring (rtCGM) on glycaemia in a predominantly indigenous (Māori) population of adults with insulin-requiring type 2 diabetes (T2D) in New Zealand.
Twelve-week, multicentre randomised controlled trial (RCT) of adults with T2D using ≥0.2 units/kg/day of insulin and elevated glycated haemoglobin (HbA1c) ≥64 mmol/mol (8.0%). Following a 2-week blinded CGM run-in phase, participants were randomised to rtCGM or control (self-monitoring blood glucose [SMBG]). The primary outcome was time in the target glucose range (3.9-10 mmol/L; TIR) during weeks 10-12, with data collected by blinded rtCGM in the control group.
Sixty-seven participants entered the RCT phase (54% Māori, 57% female), median age 53 (range 16-70 years), HbA1c 85 (IQR 74, 94) mmol/mol (9.9 [IQR 8.9, 10.8]%), body mass index (36.7 ± 7.7 kg/m). Mean (±SD) TIR increased from 37 (24)% to 53 (24)% [Δ 13%; 95% CI 4.2 to 22; P = 0.007] in the rtCGM group but did not change in the SMBG group [45 (21)% to 45 (25)%, Δ 2.5%, 95% CI -6.1 to 11, P = 0.84]. Baseline-adjusted between-group difference in TIR was 10.4% [95% CI -0.9 to 21.7; P = 0.070]. Mean HbA1c (±SD) decreased in both groups from 85 (18) mmol/mol (10.0 [1.7]%) to 64 (16) mmol/mol (8.0 [1.4]%) in the rtCGM arm and from 81 (12) mmol/mol (9.6 [1.1]%) to 65 (13) mmol/mol (8.1 [1.2]%) in the SMBG arm (P < 0.001 for both). There were no severe hypoglycaemic or ketoacidosis events in either group.
Real-time CGM use in a supportive treat-to-target model of care likely improves glycaemia in a population with insulin-treated T2D and elevated HbA1c.
研究实时连续血糖监测（rtCGM）对新西兰以毛利人为主的胰岛素依赖型 2 型糖尿病（T2D）成年患者血糖的影响。
对使用≥0.2 单位/公斤/天胰岛素和糖化血红蛋白（HbA1c）升高≥64 mmol/mol（8.0%）的 T2D 成年患者进行为期 12 周的多中心随机对照试验（RCT）。在为期 2 周的盲法 CGM 导入期后，患者被随机分配至 rtCGM 或对照组（自我监测血糖[SMBG]）。主要结局为第 10-12 周时目标血糖范围内（3.9-10 mmol/L；TIR）的时间，对照组通过盲法 rtCGM 收集数据。
67 名患者进入 RCT 阶段（54%毛利人，57%女性），中位年龄 53（16-70 岁）岁，HbA1c 85（IQR 74，94）mmol/mol（9.9 [IQR 8.9，10.8]%），体重指数（36.7±7.7）kg/m2。rtCGM 组 TIR 从 37（24）%增加到 53（24）%[Δ 13%；95%置信区间 4.2 至 22；P=0.007]，而 SMBG 组无变化[45（21）%到 45（25）%，Δ 2.5%，95%置信区间-6.1 至 11，P=0.84]。调整基线后，TIR 两组间差异为 10.4%[95%置信区间-0.9 至 21.7；P=0.070]。rtCGM 组和 SMBG 组的 HbA1c（±SD）分别从 85（18）mmol/mol（10.0 [1.7]%）降至 64（16）mmol/mol（8.0 [1.4]%）和从 81（12）mmol/mol（9.6 [1.1]%）降至 65（13）mmol/mol（8.1 [1.2]%）（均 P＜0.001）。两组均未发生严重低血糖或酮症酸中毒事件。
在支持治疗目标的治疗模式中使用实时 CGM 可能会改善接受胰岛素治疗的 T2D 和 HbA1c 升高患者的血糖水平。
