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临床试验/NCT06471322
NCT06471322终止不适用

A Multi-Disciplinary Technology-Based Care After Hospitalization for Diabetic Ketoacidosis in Patients With Type 1 Diabetes

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Measure improvement in glycemic control

研究概览

简要总结

The study team proposes that use of a novel multi-disciplinary approach with continuous glucose monitoring technology can significantly improve glycemic control and reduce readmissions among those with type 1 diabetes mellitus (T1DM) admitted for Diabetic ketoacidosis (DKA). This will also help promote a pathway for care of these patients after admission utilizing resources which are available within the Endocrinology, Diabetes and Metabolism department at the Cleveland Clinic.

详细描述

Diabetic ketoacidosis (DKA) is a serious complication of type 1 diabetes mellitus (T1DM) with significant cost to the United States of $2.2 billion over the past decade. Readmissions are very common with a 20.2% readmission rate within 30 days of discharge and 86% of those admitted with DKA having a subsequent 1-3 admissions in the following year. While predictors have been identified (i.e. lower socioeconomic status, Medicaid/Medicare, younger age, female, leaving against medical advice, etc.), few interventions have been able to concretely show a reduction in the rate of readmission apart from endocrinology consultation. Very few studies have assessed the use of a multi-disciplinary approach in this context. The only study in adults with T1DM which made use of such a team (i.e. ketoacidosis case manager, educators to provide immediate post-discharge contact and follow up along with behavioral health, education and endocrinology follow up) was done in the UK and was able to show significant improvement in readmission and glycemic control over the year-long intervention, but notably had to shut down due to lack of funding. None of these interventions consistently applied technology (i.e. continuous glucose monitoring [CGM]) which is known to be able to significantly improve glycemic control within the first month of use in those with poorly controlled T1DM.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Age 18 years old or older
  • Diagnosis of Type 1 Diabetes
  • Admitted to the hospital with confirmed DKA as determined by emergency department or admitting team
  • Compatible smart phone with the Libre 3
  • Active insurance plan

排除标准

  • Allergy to any component of the Libre 3
  • Condition which, in investigator judgement would limit their ability to participate safely

研究组 & 干预措施

Control Arm - Standard of Care, retrospective

Other

Retrospective data looking at 12 patients undergoing standard of care for diabetic ketoacidosis

干预措施: Standard of Care (Other)

Intervention Arm - Continuous Glucose Monitoring (CGM)

Active Comparator

12 patients with confirmed diabetic ketoacidosis upon hospital admission will receive continuous glucose monitor (CGM)

干预措施: Continuous Glucose Monitoring (CGM) (Device)

结局指标

主要结局

Measure improvement in glycemic control

时间窗: 6 months

To compare improvement in glycemic control (HBA1c measured in % glycosylated hemoglobin) between baseline at hospitalization for DKA and 6 months later using CGM intervention versus standard of care.

次要结局

  • Assess change in number of readmissions(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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