Washington University - Core Laboratory for Clinical Studies
St Louis, Missouri, 63108, United States
NCT Number: NCT07777900
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
St Louis, Missouri, 63108, United States
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
A few small studies have shown that glycated albumin decreases quickly after addition of a new diabetes medication. However, additional studies are needed, including those for whom dosage or frequency of diabetes medication is being changed. We wish to obtain data at multiple time points from patients with diabetes for whom a medication change is being made. Comparisons between other markers of blood glucose control with glycated albumin at various times after the change will allow us to better understand the limitations and strengths of each marker for this purpose and to make suggestions for optimal ordering time(s) for observing the change with each type of marker.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Every 4-6 months for up to 1 year
Change in glycated albumin will be determined at baseline and at every office visit. The % decrease will be examined at each time available.
Washington University School of Medicine
Other
Investigating Glycated Albumin Use for Short-Term and Additional/Alternate Monitoring of Blood Glucose Control
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07197788
Diabetes, Diabetes Mellitus
Miami, Florida, United States
View Trial DetailsNCT01316783
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT04297592
Autoimmune Diseases, Behavior
Iowa City, Iowa, United States
View Trial DetailsNCT07197775
Diabetes, Diabetes Mellitus
Quincy, Massachusetts, United States
View Trial Details