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临床试验/NCT07777900
NCT07777900Enrolling By Invitation不适用

Investigating Glycated Albumin Use for Short-Term and Additional/Alternate Monitoring of Blood Glucose Control

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月7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
100
试验地点
1
主要终点
Has patient's glucose control improved when assessed by glycated albumin measurement?

研究概览

简要总结

The goal of this observational study is to learn if the short-term glucose marker (glycated albumin) works as well or better than CGM and/or hemoglobin A1c to indicate to providers that a change in medication is working to improve patient's blood sugar control.

Participants will have a blood draw at baseline (when their provider is making a change in medication to treat their diabetes) and also every 4 weeks until the next provider visit. At the end of the study, researchers will compare the time (days, weeks) to see a change in blood glucose control with each of the markers. Participants will be enrolled for up to one year.

详细描述

A1 Study Abstract

Hemoglobin A1c (HbA1c) is a convenient way to monitor blood glucose control and is commonly used in both monitoring and diagnosing of diabetes. However, HbA1c does not quickly reflect changes in blood glucose. Alternate markers such as fructosamine or glycated albumin (GA) represent glucose control over a shorter period of time, 2-3 weeks in the case of glycated albumin versus approximately 120 days for HbA1c. A previously published study showed that glycated albumin was better than HbA1c at showing the effectiveness of a newly prescribed drug at 4 weeks and at 12 weeks. We would like to examine use of glycated albumin in addition to or instead of HbA1c for patients with diabetes who are being seen by Wash U Physicians in our outpatient clinics. We will compare this measure to other measures of glucose from their chart review or from continuous glucose monitor (CGM) data or self-monitoring blood glucose (SMBG) data they give their provider. This study is anticipated to provide evidence that using GA at an appropriate time after medication change can help providers more quickly (compared to HbA1c) assess whether or not the medication change is working. If not working, the provider can more quickly make additional adjustments. Where available, GA will also be compared with other measures of glucose control such as CGM or SMBG data or fasting blood glucose.

A2 Primary Hypothesis

Glycated albumin is an effective marker of short-term glucose control and will be effective as an earlier indicator (after 4 weeks) of whether a change in diabetes medications (e.g. dosage, frequency, or type of drug) is effective. HbA1c takes longer than this to show any meaningful change in glucose control.

A3 Purpose of the Study Protocol

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • diabetes diagnosis
  • currently using a CGM

排除标准

  • persons with cirrhosis, nutritional deficiencies, or hypoalbuminemia
  • pregnant persons

结局指标

主要结局

Has patient's glucose control improved when assessed by glycated albumin measurement?

时间窗: every 4 weeks (or as often as available) up to 1 year

Change in glycated albumin will be determined at baseline and every 4 weeks until the next office visit. The % decrease will be examined at each time available.

次要结局

  • Hemoglobin A1c change(Every 4-6 months for up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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