DelfaGLP-1 Atlas

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The Diabetes Staging System in Patient Aligned Care Teams

A Pilot Study to Test the Feasibility and Acceptability of a Novel Diabetes Staging System in Patient Aligned Care Teams in the Durham VA System

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Enrollment

120

estimated

Study population

Cardiovascular disease, Chronic kidney disease, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≥7%

Primary endpoint

•SGLT2i and/or GLP-1 agonist use after DSS EHR template use

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06142006
Org study ID1746160

Timeline

Milestones

Study start2023-09-01actual
Study first posted2023-11-21actual
Last update posted2024-04-15actual
Primary completion2024-09-01estimated
Study completion2025-09-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Cardiovascular diseaseChronic kidney diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age25 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

Eligible subjects within each PACT team will be identified retrospectively at baseline to by the study coordinator using inclusion/exclusion criteria noted below. There is no specific number of subjects that will be enrolled rather we will make a determination of % of Veterans with DM2 and CVD who are on SGLT2i/GLP-1 agonist at baseline and after 6 months of DSS use by the participating PACT teams. Veteran patients will not require consent because SGLT2i/GLP-1 agonist is standard of care in DM2 with CV disease patients.

Inclusion criteria

•male or female
•prior history of cardiovascular disease (myocardial infraction, cardiac stents, coronary artery pass, diastolic/systolic heart failure, stroke, carotid endarterectomy, femoral popliteal bypass, abdominal aortic aneurysm)
•prior history of chronic kidney disease (GFR <60, microalbumin creatinine/ratio >30 mg/g - creatinine on 3 separate occasions)
•age 25-75 years
•BMI >27
•diagnosis of type 2 diabetes
•hemoglobin A1C >7.0%
•agreeable to regular visits per study protocol
•access to telephone and reliable transportation and has an assigned PACT provider using a Freestyle Libre 2 or Freestyle lite glucometer to monitor blood sugars or willing to monitor blood sugars during study

Exclusion criteria

•age >75,
•A1C <7%
•GFR <30
•pregnant
•breast feeding
•prior history of pancreatitis will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
•prior history of gastroparesis, dysphagia will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
•history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer (contraindication to Liraglutide) will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
•history of gallstones will lead to avoidance of GLP-1 agonist therapy but not SGLT2i history of hyperoxaluria or calcium oxalate nephrolithiasis will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
•history of Roux-en-Y gastric bypass or gastric sleeve or any other bariatric procedure will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
•type 1 diabetes
•any gastrointestinal condition causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue) will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
•prior history of urinary tract infections will lead to avoidance of SGLT2i but not GLP-1 agonist therapy
•prior h/o recurrent yeast infections will lead to avoidance of SGLT2i but not GLP-1 agonist therapy
•uncircumcised male will lead to avoidance of SGLT2i but not GLP-1 agonist therapy prior h/o toe or lower extremity amputations will lead to avoidance of SGLT2i but not GLP-1 agonist therapy
•active diabetic foot ulcers or osteomyelitis will lead to avoidance of SGLT2i but not GLP-1 agonist therapy
•unwilling or unable to complete scheduled testing
•any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study
•organ transplantation or those on immunosuppressants
•chronic anticoagulation
•recent myocardial infarction, unstable angina, stroke, coronary artery bypass or transient ischemia attacks in the past 6 months
•chronic prednisone use
•deep vein thrombosis in past 6 months
•active malignancy-unstable psychiatric condition including active or current suicidal ideation
•Enrolled in another research study related to diet and/or physical activity

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
1
Glycemic / diabetes
1
Renal / kidney
1
Cardiometabolic biomarkers
1
Other clinical outcomes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight

Time frame:Baseline and 6 months after DSS implementation

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Hemoglobin A1C

Time frame:Baseline and 6 months after DSS implementation

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

1 endpoint
Secondary/protocol endpoint

GFR

Time frame:Baseline and 6 months after DSS implementation

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Blood pressure

Time frame:Baseline and 6 months after DSS implementation

change from baseline, improvement

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

SGLT2i and/or GLP-1 agonist use after DSS EHR template use

Time frame:Baseline and 6 months after DSS implementation

threshold achievement, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.