Pediatrics Owning Performance Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
A more convenient blood glucose monitoring system integrated with a responsive mobile health app may facilitate improved diabetes control in adolescent and young adult patients with Type 1 diabetes. The primary aim of this study is to determine if the POPS diabetes management system can improve diabetes control in the adolescent and young adult population. The investigators hypothesize that use of the POPS diabetes management device and mobile application (app) will be associated with lower HbA1C after 6-months of use in adolescent and young adult T1D patients.
详细描述
This is a prospective, single-arm, single-subject clinical trial to study outcomes related to device use in the pediatric diabetes population. Patients will be recruited at the Children's Minnesota McNeely Diabetes Clinic and satellite clinics during routine office visits over a 6-month period until recruitment goals are met. Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months with periodic check-ins and follow-ups. Primary outcome, HbA1c, will be measured at baseline and 6-month follow-up. Secondary aims include assessment of blood glucose testing frequency and quality of life scores following 6-months of device and app use. The investigators will also describe sustained use over the study period, average blood glucose and variability, and frequency of hypoglycemic events (blood glucose <70). Historical data for each patient will also be recorded from medical records, with each patient serving as their own comparative control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes, diagnosed at least 6 months prior to enrollment
- •Aged ≥10 years, ≤25 years
- •Daily insulin of any type, administered as multiple daily injections (MDI) for at least 90 days prior to enrollment
- •Latest HbA1c ≥8.0%, ≤10.5%
- •Average self-blood glucose measurement frequency ≥2 per day and ≤4.5 per day based on meter download spanning 28-day period prior to qualifying HbA1c measurement
- •User of iPhone 5 or above with iOS above 10.0
- •English-speaking
- •Patient must be willing to only use POPS device to check blood glucose for duration of study (except in case of technical failure or emergency)
排除标准
- •Continuous glucose monitor user at time of enrollment or considering CGM use in the next 6 months
- •Concurrent participation in another study that may influence results
- •On insulin pump at time of recruitment or considering pump use in the next 6 months
- •Inability to perform self-care behaviors due to co-morbidities such as mental health disorder, developmental delay, or other prohibitive physical condition (blindness, etc)
- •Participation in a diabetes clinical trial intervention in the 12 months prior to enrollment
结局指标
主要结局
HbA1c
时间窗: 6 months
Change in HbA1c from baseline to 6 months
次要结局
- Testing frequency(30 days prior to enrollment to 6 months post-enrollment)
- quality of life(30 days prior to enrollment to 6 months post-enrollment)
- Average blood glucose(30 days prior to enrollment to 6 months post-enrollment)
- Blood glucose variability(30 days prior to enrollment to 6 months post-enrollment)
- Hypoglycemia(6 months)
研究者
Laura Gandrud
Principal Investigator
Children's Hospitals and Clinics of Minnesota