ACTRN12618000320257已完成未知
A randomised controlled trial investigating flash glucose monitoring targeting glycaemic control among adolescents with sub-optimally controlled type 1 diabetes
Department of Women's and Children's Health, DSM0 个研究点目标入组 64 人开始时间: 2018年3月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
For youth with high-risk glycemic control, flash glucose monitoring led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycaemic control over usual care with self-monitoring blood glucose at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 13 Years 至 20 Years（—）
- 性别
- All
入选标准
- •1) aged 13 to 20 years, inclusive;
- •2)diagnosed with T1D for at least 12 months;
- •3)mean HbA1c of >= 75 mmol/mol over the past 6 months;
- •4)>0.5 units of insulin/kg/day (with no restrictions based on insulin regimen);
- •5)plans to continue with routine clinical care during the 6-month study;
- •6)currently residing in and expecting to remain in regions served by the Canterbury, Capital and Coast, South Canterbury, and Southern District Health Boards for the following year;
- •7)the ability to understand study procedures and to comply with them for the entire length of the study.
排除标准
- •1)Any severe diabetes related complications (nephropathy on treatment, retinopathy with associated visual loss – milder degrees will not be excluded);
- •2)Other severe uncontrolled medical or psychiatric co-morbidity/severe mental illness;
- •3)currently using a CGM device or has used one continuously (other than for intermittent hospital use) within the previous 4 months;
- •4)participation in another device or drug study that could affect glucose measurements during the study period;
- •5)pregnancy, lactation, or plans to become pregnant;
- •6)inability of individual or legal guardian to give written informed consent.
研究者
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