The Diabetes Staging System in Patient Aligned Care Teams

NCT06142006 | Recruiting

• 1 other identifier: 1746160
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 cardiovascular disease and/or chronic kidney disease.

Conditions

Diabetes Mellitus; Type 2 Diabetes

Outcome Measures

Primary Outcomes (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.

  Baseline and 6 months after DSS implementation

Secondary Outcomes (4)

• Weight

  Baseline and 6 months after DSS implementation

• Blood pressure

  Baseline and 6 months after DSS implementation

• Hemoglobin A1C

  Baseline and 6 months after DSS implementation

• GFR

  Baseline and 6 months after DSS implementation

Interventions

Diabetes Staging System (DSS) use among Primary Care Teams OTHER

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

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Greenville VA Health Care Center, 401 Moye Blvd

Greenville, North Carolina, 27834, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 30568472 BACKGROUND

• 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.

  PMID: 36700391 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Moahad S Dar, MD

  Department of Veterans Affair, Durham VAHCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadya T Majette, MPH

CONTACT

252-830-2149; Nadya.Majette@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: November 21, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)