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Diabetes MellitusNCT06142006

The Diabetes Staging System in Patient Aligned Care Teams

An observational study of Diabetes Mellitus and Type 2 Diabetes, run by Durham VA Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System (DSS) in Patient Aligned Care Teams (PACT) teams and its ability to increase sodium-glucose cotransporter-2 inhibitor (SGLT2i) and glucagon-like-1 peptide (GLP-1) use in Veteran patients with type 2 diabetes and… Read more about this study

Who is it for?
Ages 25 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2 Diabetes
What is being tested?
Diabetes Staging System (DSS) use among Primary Care Teams
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Sep 2023to 1 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

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 25 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Nadya T Majette, MPH contact

252-830-2149 ext. 143493

Nadya.Majette@va.gov

United States1 site, 1 recruiting

  • Greenville VA Health Care Center, 401 Moye Blvd

    Greenville, North Carolina, 27834

    Nadya T Majette, MPH, 252-830-2149 ext. 143493, Nadya.Majette@va.gov

    Recruiting

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About this study

Official title: 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

The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System (DSS) in Patient Aligned Care Teams (PACT) teams and its ability to increase sodium-glucose cotransporter-2 inhibitor (SGLT2i) and glucagon-like-1 peptide (GLP-1) use in Veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.

Read the detailed description

The Diabetes Staging System (DSS) is a novel type 2 diabetes (DM2) staging system patterned after Tumor Node Metastasis (TNM) cancer staging that uses the number of macrovascular and microvascular complications and most recent A1C and glomerular filtration rate (GFR) to determine DSS stage which reflects disease severity. The DSS stage is then linked to specific evidence-based clinical interventions that decrease morbidity and mortality. One of the most important clinical interventions of the DSS is recommending a SGLT2i/GLP-1 agonist in DM2 patients with CVD which helps address the inequity of low overall SGLT2i/GLP-1 use. The DSS has been adapted into a CPRS-DSS template available to all PACT providers within the Durham VA system which could address the racial differences in SGLT2i/GLP-1 agonist use. DSS offers a systematic approach to DM2 care (Stage DM2 -determine medical therapy based on DM2 stage) that has the potential to address inequities related to SGLT2i/GLP-1 overall use and racial differences in use. Primary Care Aligned Teams (PACT) are best positioned to use the DSS because they treat the vast majority of Veteran DM2 patients. This pilot proposal will seek to address inequities in SGLT2i/GLP-1 agonist use within in the VA by examining the feasibility and acceptability of the DSS among 12 different PACT teams within the Durham VA Medical System by measuring its ability to increase SGLT2i/GLP-1 agonist after 6 months of DSS implementation.

Being tested
Diabetes Staging System (DSS) use among Primary Care Teams
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes Staging System (DSS) use among Primary Care TeamsOther

    Evaluate the feasibility of using the DSS in PACT clinics to increase SGLT2i and/or GLP-1 agonist use in Veteran DM2 patients with cardiovascular disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Percentage of Caucasian and African American DM2 Veteran patients with CVD who are on SGLT2i and/or GLP-1 agonist at baseline and 6 months after provider DSS EHR template use.

    Measured: Baseline and 6 months after DSS implementation

Secondary outcomes (4)

  1. Weight

    Measured in pounds

    Measured: Baseline and 6 months after DSS implementation

  2. Blood pressure

    Measures systolic and diastolic blood pressure in mmHG

    Measured: Baseline and 6 months after DSS implementation

  3. Hemoglobin A1C

    Measures average blood sugars control over the past 3 months

    Measured: Baseline and 6 months after DSS implementation

  4. GFR

    Measures glomerular filtration rate

    Measured: Baseline and 6 months after DSS implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06142006
Sponsor's protocol ID
1746160
Status last verified
Apr 2024
First submitted
21 Sep 2023
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dar MS, Beg SA. TNM cancer staging: can it help develop a novel staging system for type 2 diabetes? Diabetes Metab Syndr Obes. 2018 Nov 28;11:845-853. doi: 10.2147/DMSO.S179963. eCollection 2018.

    PubMed 30568472

  • Dar MS, Wanner C, Marx N, Ofstad AP, Mattheus M, Kaspers S, Beg SA. Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes. Diabetes Obes Metab. 2023 May;25(5):1372-1384. doi: 10.1111/dom.14989. Epub 2023 Mar 6.

    PubMed 36700391

  • Dar MS, Zhang J, Ashline A, Kota S, Woolson S, Majette NT, Bosworth HB. The Diabetes Staging System (DSS): A Pilot Study Assessing Feasibility, Provider Engagement and Implementation Challenges of a Novel Staging System for Type 2 Diabetes. Diabetes Metab Syndr Obes. 2026 Apr 9;19:556175. doi: 10.2147/DMSO.S556175. eCollection 2026.

    PubMed 41982645

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Type 2 Diabetes, run by Durham VA Medical Center 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 9 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nadya T Majette, MPH (252-830-2149 ext. 143493, Nadya.Majette@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SGLT2i and/or GLP-1 agonist use after DSS EHR template use (time frame: Baseline and 6 months after DSS implementation). 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 NCT06142006, which also lists 3 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 15 Apr 2024.

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