DiabetesNCT07777900
Glycated Albumin Monitoring
An observational study of Diabetes, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with a diagnosis of diabetes who are seeing their doctor and ideally utilize a CGM.
Who may be able to join
- diabetes diagnosis
- currently using a CGM
Who cannot join
- persons with cirrhosis, nutritional deficiencies, or hypoalbuminemia
- pregnant persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University - Core Laboratory for Clinical Studies
St Louis, Missouri, 63108
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetes
- Keywords
- Diabetes, glucose monitoring, short-term glucose control, glycated albumin, treatment changes
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 4 weeks (or as often as available) up to 1 year
Secondary outcomes (1)
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.
Measured: Every 4-6 months for up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start7 Jul 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777900
- Sponsor's protocol ID
- 202412159
- Other IDs
- JIT1246
- Status last verified
- Aug 2026
- First submitted
- 6 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shima K, Komatsu M, Noma Y, Miya K. Glycated albumin (GA) is more advantageous than hemoglobin A1c for evaluating the efficacy of sitagliptin in achieving glycemic control in patients with type 2 diabetes. Intern Med. 2014;53(8):829-35. doi: 10.2169/internalmedicine.53.1364. Epub 2014 Apr 15.
PubMed 24739602Desouza CV, Rosenstock J, Kohzuma T, Fonseca VA. Glycated Albumin Correlates With Time-in-Range Better Than HbA1c or Fructosamine. J Clin Endocrinol Metab. 2023 Oct 18;108(11):e1193-e1198. doi: 10.1210/clinem/dgad298.
PubMed 37259605
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Glycated Albumin Use for Short-Term and Additional/Alternate Monitoring of Blood Glucose Control
- ClinicalTrials.gov ID
- NCT07777900
- Acronym / sponsor ID
- 202412159
- Conditions
- Diabetes
- Keywords
- Diabetes, glucose monitoring, short-term glucose control, glycated albumin, treatment changes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with a diagnosis of diabetes who are seeing their doctor and ideally utilize a CGM.
Key inclusion criteria (2 listed)
- diabetes diagnosis
- currently using a CGM
Key exclusion criteria (2 listed)
- persons with cirrhosis, nutritional deficiencies, or hypoalbuminemia
- pregnant persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Has patient's glucose control improved when assessed by glycated albumin measurement?
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.
1 secondary outcome
Hemoglobin A1c change
Time frame: Every 4-6 months for up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 24739602Shima K, Komatsu M, Noma Y, Miya K. Glycated albumin (GA) is more advantageous than hemoglobin A1c for evaluating the efficacy of sitagliptin in achieving glycemic control in patients with type 2 diabetes. Intern Med. 2014;53(8):829-35. doi: 10.2169/internalmedicine.53.1364. Epub 2014 Apr 15.
- Background: PubMed 37259605Desouza CV, Rosenstock J, Kohzuma T, Fonseca VA. Glycated Albumin Correlates With Time-in-Range Better Than HbA1c or Fructosamine. J Clin Endocrinol Metab. 2023 Oct 18;108(11):e1193-e1198. doi: 10.1210/clinem/dgad298.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Has patient's glucose control improved when assessed by glycated albumin measurement? (time frame: every 4 weeks (or as often as available) up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777900, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.