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临床试验/NCT00829062
NCT00829062撤回不适用

Presenting Evidence Based Practice to an Insurance Provider to Expand Coverage of Continuous Subcutaneous Insulin Infusion (CSII) in Pediatric Patients With Diabetes

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
The aim of this project is to present evidence based practice to Missouri Medicaid to expand coverage of continuous subcutaneous insulin infusion (CSII) in pediatric patients with diabetes. - Hemoglobin A1C

研究概览

简要总结

The purpose of the study is to present evidence based literature and clinical data to the medical directors at Missouri Medicaid to help modify the existing policy regarding insulin pump therapy in pediatric patients with diabetes.

详细描述

Results from the Diabetes Control and Complications Trial (DCCT) showed that more aggressive and intensive management of diabetes leads to a reduction in the incidence of diabetes related complications in adolescents and adults. Therefore, early initiation of intensive insulin regimens that have been proven to normalize blood sugars as much as possible need to be initiated in youth with type 1 diabetes mellitus (T1DM) to improve outcomes in adulthood. However, despite this understanding, there remains no consensus for how to best manage insulin delivery in children diagnosed with T1DM.

Intensive insulin treatment of diabetes typically entails one of two therapies: MDI (multiple daily injections) or CSII also know as insulin pump therapy. MDI requires several insulin injections per day to achieve near normal glycemic control which can also lead to a subsequent increased risk of severe hypoglycemia. The insulin pump allows the user to program in various basal insulin rates, as low as 0.025 units/hr, throughout the day and night to better match one's physiologic insulin secretion, and eliminates the need for insulin injections throughout the day.

Management of T1DM in the pediatric setting presents several challenges for the patient, caregivers, and health care providers. Children and adolescents tend to have wide fluctuations in their blood glucose levels due to varying amounts of physical activity from day to day. Additionally, infants, toddlers, and school age children have eating habits that are very unpredictable and often eat small quantities making it quite difficult to accurately administer small doses of insulin through an insulin syringe or pen device. Finally, there is increasing evidence to support that infants and toddlers who experience severe hypoglycemia may have resultant neurologic deficits. Previous research has demonstrated that pediatric patients on insulin pump therapy had better glycemic control when compared to pediatric patients who were managed on MDI alone. Patients on insulin pumps and their parents have reported more flexibility with meals and daily activities, lower hemoglobin A1c levels, decreased variability in blood sugar readings, and fewer episodes of hypoglycemia.

Despite the vast research documenting the benefits of insulin pump therapy, some insurance companies continue to be hesitant in covering CSII in pediatric patients with diabetes. The findings from this study and supporting evidence will be presented to medical directors at Missouri Medicaid to help expand coverage of CSII in pediatric patients with diabetes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
12 Months 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 12 months-17 years old diagnosed with Type I Diabetes Mellitus receiving diabetes care at Children's Mercy Hospital
  • Patients/families must be able to read and speak English
  • Patients will need to have had a minimum of 3 clinic visits over the past year
  • Patients who are recipients of Missouri Medicaid that have been denied or are awaiting Medtronic MiniMed insulin pump coverage
  • Patients receiving insulin injections

排除标准

  • Non Missouri Medicaid patients on insulin injections
  • Recipients of Missouri Medicaid who are currently on insulin pump therapy

结局指标

主要结局

The aim of this project is to present evidence based practice to Missouri Medicaid to expand coverage of continuous subcutaneous insulin infusion (CSII) in pediatric patients with diabetes. - Hemoglobin A1C

时间窗: 12 months

次要结局

  • Glycemic variability as shown by continuous glucose recording(3-5 days)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other

研究点 (2)

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