Investigating Glycated Albumin Use for Short-Term and Additional/Alternate Monitoring of Blood Glucose Control
Investigating Glycated Albumin Use for Short-Term and Additional/Alternate Monitoring of Blood Glucose Control
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.
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.
Inclusion Criteria:
Exclusion Criteria: