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临床试验/NCT06353217
NCT06353217
已完成
不适用

Pilot Study of a Primary Care Hypoglycemia Prevention Program

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 35 人2024年5月22日

概览

阶段
不适用
干预措施
Patient Group (Hypoglycemia Prevention Program)
疾病 / 适应症
Diabetes Mellitus
发起方
Johns Hopkins University
入组人数
35
试验地点
1
主要终点
Overall acceptability to clinic staff
状态
已完成
最后更新
23天前

概览

简要总结

This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.

注册库
clinicaltrials.gov
开始日期
2024年5月22日
结束日期
2026年2月1日
最后更新
23天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • for patients:
  • Age 18 years or older
  • Diabetes mellitus by electronic health record review
  • Treatment with any of the following medication classes: insulin, sulfonylureas, meglitinides
  • Community dwelling (not residing in long-term care or a skilled nursing facility)
  • Receiving primary care from a participating primary care provider at Johns Hopkins Internal Medicine at Green Spring Station
  • The patient's primary care provider approves their participation

排除标准

  • for patients:
  • Significant cognitive impairment or dementia
  • Receiving hospice or end of life care
  • Any other serious illness or condition not compatible with participation as determined by the investigators
  • Planning to leave area prior to end of study
  • Investigator discretion
  • Exclusion Criteria for continuous glucose monitoring (not required for study participation):
  • History of allergic skin reaction to adhesive
  • Implantable pacemaker
  • Inclusion criteria for primary care providers:

研究组 & 干预措施

Primary care hypoglycemia prevention program

干预措施: Patient Group (Hypoglycemia Prevention Program)

Primary care hypoglycemia prevention program

干预措施: Primary Care Physician Group

Primary care hypoglycemia prevention program

干预措施: Clinic Staff Group

结局指标

主要结局

Overall acceptability to clinic staff

时间窗: Immediately after the intervention

Mean score for overall acceptability on clinic staff intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)

Overall acceptability to primary care providers

时间窗: Immediately after the intervention

Mean score for overall acceptability on primary care provider intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)

Overall acceptability to patients

时间窗: Immediately after the intervention

Mean score for overall acceptability on patient intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)

研究点 (1)

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