Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in the number of missed meal boluses
研究概览
简要总结
This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.
详细描述
This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13 and over
- •On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM
- •Willing to wear a CGM at least 70% of the time while in the study
- •Using an iPhone
- •Willing to wear an Apple watch on their dominant hand while awake
- •Missing or late in giving at least four food boluses in the previous two weeks
- •Understanding and willingness to follow the protocol and sign informed consent
- •Ability to speak, read and write in the language of the investigators
排除标准
- •Pregnant or lactating
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- •Current treatment for a seizure disorder
- •Inpatient psychiatric treatment in the past 6 months
- •Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. They may be participating in another trial, if this study is approved by the investigators of the other trial.
研究组 & 干预措施
Standard Care
Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory
Klue
Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software.
干预措施: Klue (Device)
结局指标
主要结局
Change in the number of missed meal boluses
时间窗: The two weeks prior to each study visit
A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise.
次要结局
- Positive predictive value of a Klue meal alert(All data for the 6 weeks on the Klue intervention arm when Klue is active)
- Change in time in range(data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject)
研究者
Bruce Buckingham
Professor of Pediatric Endocrinology
Stanford University