Wild Sarah H, Hanley Janet, Lewis Stephanie C, McKnight John A, McCloughan Lucy B, Padfield Paul L, Parker Richard A, Paterson Mary, Pinnock Hilary, Sheikh Aziz, McKinstry Brian
Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, Scotland, United Kingdom.
Edinburgh Napier University School of Nursing, Midwifery and Social Care, Edinburgh, Scotland, United Kingdom.
PLoS Med. 2016 Jul 26;13(7):e1002098. doi: 10.1371/journal.pmed.1002098. eCollection 2016 Jul.
Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.
We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45-12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention.
Supported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628.
Current Controlled Trials ISRCTN 71674628.
对于未接受胰岛素治疗的2型糖尿病患者，自我血糖监测似乎并不能有效改善血糖控制。我们调查了医疗保健专业人员对通过遥测传输的自我监测血糖结果进行审查，是否能改善血糖控制不佳的2型糖尿病患者的血糖水平。
我们在英国四个地区的家庭医疗中心进行了一项随机、平行、研究者盲法对照试验，采用集中随机分组，纳入321例糖化血红蛋白（HbA1c）>58 mmol/mol的2型糖尿病患者。支持性远程监测干预措施包括自我测量并将每周两次的晨起和晚间血糖值传输至一个安全网站，供不了解分组情况的家庭医疗临床医生进行审查。对照组接受常规护理，血糖或血压控制不佳者至少每年接受一次审查，审查频率更高。9个月时评估的HbA1c是主要结局指标。进行意向性分析。2011年6月6日至2013年7月19日期间，160人被随机分配至干预组，161人被随机分配至常规护理组。干预组146人、对照组139人有随访时的HbA1c数据。随访时干预组的平均（标准差）HbA1c为63.0（15.5）mmol/mol，常规护理组为67.8（14.7）mmol/mol。在初步分析中，调整后的平均HbA1c低5.60 mmol/mol / 0.51%（95%置信区间2.38至8.81 mmol/mol / 95%置信区间0.22%至0.81%，p = 0.0007）。在进行基线差异和最小化分层调整后，与常规护理相比，干预组患者的调整后平均动态收缩压低3.06 mmHg（95%置信区间0.56 - 5.56 mmHg，p = 0.017），平均动态舒张压低2.17 mmHg（95%置信区间0.62 - 3.72，p = 0.006）。在次要分析中，两组在体重、治疗模式、药物依从性或生活质量方面未发现显著差异。不良事件较少，且在干预组和对照组中分布均匀。在次要分析中，与对照组相比，干预组的执业护士与患者之间的电话通话次数更多（率比7.50（95%置信区间4.45 - 12.65，p < 0.0001），但两组在使用医疗服务方面未发现其他显著差异。主要局限性包括试验参与者可能缺乏代表性、无法使参与者和医疗保健专业人员设盲，以及对作用机制、效果持续时间和最佳干预时长存在不确定性。
在家庭医疗中，支持性远程监测使2型糖尿病患者的血糖控制取得了具有临床意义的改善。当前受控试验，注册号ISRCTN71674628。
当前受控试验ISRCTN 71674628。
