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临床试验/NCT06906653
NCT06906653Enrolling By Invitation不适用

Population Health Management for Kaiser Permanente Northern California (KPNC) Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
204
试验地点
2
主要终点
Average hemoglobin A1c (HbA1c)

研究概览

简要总结

This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-74 years
  • Newly diagnosed with type 2 diabetes
  • Kaiser Permanente Northern California member receiving care in a participating service area
  • If age ≤45 years, then HbA1c>8%
  • If age<45 years, then HbA1c>10%

排除标准

  • Individuals who are pregnant
  • Individuals with likely type 1 diabetes (T1D)

结局指标

主要结局

Average hemoglobin A1c (HbA1c)

时间窗: 12-months

Between-arm differences in HbA1c

次要结局

  • Time to achievement of glycemic targets(12-months)
  • Adherence to HbA1c monitoring(12-months)
  • Type 2 diabetes medication and statin initiation(12-months)
  • Type 2 diabetes medication adherence(12-months)
  • Completion of preventative screening(12-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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