Garg Satish K, Shah Viral N, Akturk Halis K, Beatson Christie, Snell-Bergeon Janet K
Barbara Davis Center for Diabetes, University of Colorado Anschutz Campus, Aurora, CO, USA.
School of Medicine, University of Colorado, Aurora, CO, USA.
Diabetes Ther. 2017 Aug;8(4):811-819. doi: 10.1007/s13300-017-0272-5. Epub 2017 May 29.
The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.
The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano and an intervention group using SMBG with iPhone plus glucose meter (iBGStar). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.
Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32).
The use of iBGStar resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.
ClinicalTrials.gov: NCT01825382.
Sanofi.
移动技术在1型糖尿病（T1D）成人患者报告结局（PRO）及血糖控制中的作用有待进一步评估。
这项单中心、前瞻性、为期6个月的开放标签、研究者发起的研究，将100例T1D患者按1:1比例随机分为对照组和干预组。对照组使用罗氏卓越纤巧型血糖仪进行自我血糖监测（SMBG），干预组使用iPhone加血糖仪（iBGStar）进行SMBG。主要终点为PRO的变化（低血糖恐惧评分、行为和担忧子评分）。次要结局为血糖变异性指标的改善及糖化血红蛋白（A1c）值的降低。
两组的基线人口统计学特征和糖化血红蛋白（A1c）值相似。与对照组相比，iBGStar组在6个月时A1c值显著降低（-0.16对-0.51，p = 0.04）。iBGStar组在3个月时总胰岛素剂量显著增加，但在6个月时未改变。两组在6个月时低血糖恐惧量表（PRO）均有所改善（-1.4±10.0对-3.9±12.5，p = 0.32）。
与对照组相比，使用iBGStar在6个月时能实现更好的血糖控制，并改善一些PRO（低血糖恐惧和行为评分），且低血糖风险未增加。
ClinicalTrials.gov：NCT01825382。
赛诺菲。
