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临床试验/NCT02835183
NCT02835183撤回不适用

Prospective Evaluation of iDECIDE: A Smartphone App for Insulin Bolus Dosing

Arizona State University0 个研究点开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Compare mean postprandial glucose level

研究概览

简要总结

The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows.

详细描述

The investigators will seek approval from Mayo Clinic and Arizona State University Institutional Review Board to recruit 30 type 1 diabetes adult outpatients using insulin pumps and continuous glucose monitoring system from the Endocrinology Clinic at Mayo Clinic Arizona. First, participants will complete a questionnaire to self-assess their confidence to count carbs from food/drinks, personal perceptions on how exercise/alcohol affect their blood glucose, and how they learned about it (e.g., trial and error, education from providers), and compensation techniques used to adjust for exercise performed/alcohol consumed (for instance, adjust for basal rate or adjust insulin boluses). Stored glucose data will be analyzed for the previous 8 weeks prior to entry to establish patient-specific upper and lower bounds for determining excessive blood glucose highs and lows. Second, participants will be randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. Throughout the 8 weeks, study participants will be asked to wear a wristband heart rate accelerometer that will provide data on time and duration of exercise performed. Also, during the 8 weeks, study participants will use their glucose sensor and pump to measure blood glucose and to deliver basal insulin. During the 4 weeks when participants receive recommendations from iDECIDE, the pump's bolus calculator will be turned off so participants will receive no insulin bolus recommendations from pump. While receiving recommendations from iDECIDE, participants will use the pump to manually deliver insulin boluses and can either use the advice from iDECIDE or override it.

The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators will be: mean postprandial glucose level and number of events with excessive blood glucose highs and lows. Potential secondary outcomes: mean percentage of time with low glucose level and time spent in the target glucose range.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Mayo Clinic Arizona type 1 diabetes outpatients,
  • •Older than 18 years and younger than 60,
  • •Non-pregnant,
  • •English speakers,
  • •Who use Medtronic insulin pumps and continuous glucose monitoring sensors,
  • •Own a smartphone,
  • •Have kept in consistent contact with the Mayo Clinic Division of Endocrinology health care team during the last year, and have use the same insulin pump and continuous glucose sensor for at least one year.

排除标准

  • •Subjects who do not satisfy the inclusion criteria.

研究组 & 干预措施

Insulin pump followed by iDECIDE

Experimental

Participants will be randomly assigned to 4 weeks of using their insulin pump to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing.

干预措施: iDECIDE (Device)

Insulin pump followed by iDECIDE

Experimental

Participants will be randomly assigned to 4 weeks of using their insulin pump to decide insulin boluses and then 4 weeks of using iDECIDE to receive recommendations for insulin dosing.

干预措施: Insulin pump (Device)

iDECIDE followed by insulin pump

Experimental

Participants will be randomly assigned to 4 weeks of using iDECIDE to receive recommendations for insulin dosing and then 4 weeks of using their insulin pump to decide insulin boluses.

干预措施: iDECIDE (Device)

iDECIDE followed by insulin pump

Experimental

Participants will be randomly assigned to 4 weeks of using iDECIDE to receive recommendations for insulin dosing and then 4 weeks of using their insulin pump to decide insulin boluses.

干预措施: Insulin pump (Device)

结局指标

主要结局

Compare mean postprandial glucose level

时间窗: 2 months

Compare iDECIDE's insulin dosing algorithm against the pump calculators in terms of mean postprandial glucose level

次要结局

  • Hyperglycemia events(2 months)
  • Hypoglycemia events(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adela Grando

Assistant Professor

Arizona State University

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