An observational study in Diabetes, sponsored by Washington University School of Medicine. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Washington University School of Medicine · Observational
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Among 46 studies in Diabetes Mellitus by Washington University School of Medicine — 3 open to participants now, 5 under way, none of them phase 3. Diabetes Mellitus · Washington University School of Medicine.
Among the 46 studies in Diabetes Mellitus by Washington University School of Medicine, this one is the 6th largest by planned enrollment of the 10 observational ones that give a count, is the only one that started in 2025, is one of 10 observational ones, and was the 45th registered.
8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.
Browse Diabetes Mellitus studies →3 of the 46 studies in Diabetes Mellitus by Washington University School of Medicine are open now, in 2 countries. Recruiting first, the newest first:
Washington University School of Medicine · Sites in Nigeria
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 0+
By country, each count listing its studies:
Of the 649 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 3 · Phase 3 2 · Phase 4 2
First in 1992; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Median enrollment 58 across the 35 interventional studies, 101 across the 10 observational. Of the 37 that completed or were terminated, 18 (49%) have results posted.
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Washington University School of Medicine is the lead sponsor of 1,804 studies on the registry; 270 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
2 of the studies in Diabetes Mellitus by Washington University School of Medicine that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07777900Washington University School of MedicineGlycated Albumin Monitoring | 2027-01-15 |
| NCT02841553Washington University School of MedicineWolfram Syndrome and WFS1-related Disorders International Registry and Clinical Study | 2027-04 |
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Among the 46 studies in Diabetes Mellitus by Washington University School of Medicine, from their registry updates:
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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.
Persons with a diagnosis of diabetes who are seeing their doctor and ideally utilize a CGM.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has patient's glucose control improved when assessed by glycated albumin measurement?
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 weeks (or as often as available) up to 1 year
Hemoglobin A1c change
Change in glycated albumin will be determined at baseline and at every office visit. The % decrease will be examined at each time available.
Time frame: Every 4-6 months for up to 1 year
Plan to share: Undecided
Started Jul 2025 (actual). Primary completion is estimated for Jan 2027, 18 months after the start.
Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 159. This study's planned 18 months is below that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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