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临床试验/NCT05036343
NCT05036343已完成不适用

Smart Insulin Pens: A Randomized, Crossover Prospective Interventional Pilot Study Assessing the Effect on Glycemic Control and Diabetes Related Burdens

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
13
试验地点
2
主要终点
InPen® Missed Insulin Injections

研究概览

简要总结

The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.

详细描述

Investigators will perform a randomized, cross-over prospective interventional study. Half of the participants will be randomized to the InPen® and the other half will continue with their conventional insulin injection protocol. After 90 days, participants will switch to the second arm. Randomization will occur via block randomization. Teaching to use the InPen® will be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a telemedicine visit if it does not align with clinic visit. You will be followed for three months with hemoglobin A1c at the beginning and the end of the study. Data from the (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high (>180-250 mg/dL), very high(> 250 mg/dL), low(54-70 mg/dL) and very low(<54 mg/dL), along with total daily insulin dose. Data on missed insulin doses will be assessed via data from the InPen®. You will be randomized to traditional injections we will ask them to record missed insulin doses weekly. You should still adjust insulin doses at home, like they do at baseline. If insulin adjustments are made while in one arm of the study they should still continue that dosing when they cross over. Investigators will also assess quality of life and fatigue related to technology with surveys prior to start of the study and at the end. Specifically, investigators will assess diabetes distress, transition readiness, and parental experience of childhood illness scales. Investigators will also utilize the insulin delivery satisfaction survey to assess how you view your current regimen and then how you view the effects of the InPen in managing your type 1 diabetes.

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 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals between the ages of 13 and 21 years.
  • Patients with Type 1 diabetes for at least 6 months
  • Defined as either a c peptide <1 , one or more positive diabetes autoantibodies, or a clinical diagnosis with age of onset prior to puberty
  • Patients who currently receive insulin injections with a CGM.
  • English speaking.
  • Have access to a smart phone. on an insulin to carbohydrate ratio

排除标准

  • Individuals less than 13
  • Non-English speaking.
  • No access to a smart phone.
  • Intellectual disability that would impact their ability to utilize the technology
  • Known pregnant women taking chronic steroids (equivalent equal to or greater then 5mg of prednisone daily)

结局指标

主要结局

InPen® Missed Insulin Injections

时间窗: 30 and 90 days

Number of missed insulin injections after 30 and 90 days of InPen and CGM

Change in Hemoglobin A1c

时间窗: Baseline, 3 months

Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Unit of measure = percent of glycated hemoglobin

Glucose Time in Range

时间窗: 3 months

The percentage of time that glucose readings are in goal range (70-180 mg/dL)

Glucose

时间窗: 3 months

Mean glucose levels at 6 months. Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL

次要结局

  • Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score(Baseline, 3 months)
  • Change in Diabetes Distress Scale Score(Baseline, 3 months)
  • Change in Transition Readiness(Baseline, 3 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana L. Creo

Principal Investigator

Mayo Clinic

研究点 (2)

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