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临床试验/NCT01829555
NCT01829555已完成不适用

A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

UConn Health2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年2月1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
入组人数
10
试验地点
2
主要终点
change from baseline in number of self-monitoring of blood glucose tests conducted

研究概览

简要总结

Glucose control is necessary to avoid the immediate and long-term adverse effects associated with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important step to achieving glucose control. Data suggest that large proportions of adolescents and young adults fail to adhere to standard guidelines of self-monitored of blood glucose testing and have hemoglobin A1c levels >7.5%. A finite period of poor metabolic control can lead to increased risk of medical complications over an individual's lifespan, necessitating novel interventions to improve self-monitored blood glucose testing and metabolic control in emerging adults with type 1 diabetes. The investigators treatment approach, which provides direct tangible reinforcement for objective evidence of behavior change, is efficacious in decreasing substance use, reducing weight, and improving medication adherence.

The purpose of this project is to develop and pilot test an intervention based on behavioral economic principles for improving self-monitored blood glucose testing in young persons with type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they test, and a return text will inform them of reinforcer vouchers earned. The investigators will collect data on self-monitored blood glucose testing frequency and A1c levels preceding treatment initiation and throughout a 6 month treatment period. If promising, a randomized trial will lead to larger scale evaluations of reinforcement interventions alone, or in combination with multimodal treatment approaches, and it may be applied to other clinical issues such as adherence to continuous glucose monitoring. Importantly, this intervention can be administered remotely and in an automated fashion, allowing for widespread adoption if efficacious.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 15-21 years old
  • diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines (Silverstein et al., 2005)
  • average A1c >7.5% and <11% during the year before study entry, and most recent A1c >7.5% but <11%
  • SMBG user with clinical recommendations to test >4 times/day
  • past month SMBG <4 times/ day on average
  • English speaking and able to read at >5th grade level

排除标准

  • have a major psychiatric or neurocognitive disorder that would inhibit participation
  • have a major visual impairment
  • meet DSM-IV criteria for pathological gambling
  • have a significant other medical condition that impacts diabetes management
  • plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched
  • are pregnant or trying to become pregnant
  • are participating in another clinical trial

结局指标

主要结局

change from baseline in number of self-monitoring of blood glucose tests conducted

时间窗: 6 months

次要结局

  • change from baseline in hemoglobin A1c levels(6 months)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

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