Recruiting

Diabetes Staging System

Sponsor:

Durham VA Medical Center

Code:

NCT06142006

Conditions

Diabetes Mellitus

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

Diabetes Staging System (DSS) use among Primary Care Teams

Study Details

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

Study ID

NCT06142006

Start date

Sep 1, 2023

Status verified date

Apr, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

Diabetes Staging System (DSS) use among Primary Care Teams

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

Primary outcome measure

  • SGLT2i and/or GLP-1 agonist use after DSS EHR template use [ Time Frame: Baseline and 6 months after DSS implementation ]

Central Contacts and Locations

Central contacts

Nadya T Majette, MPH

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

Locations

Greenville VA Health Care Center, 401 Moye Blvd

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Nadya T Majette, MPH

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

More Information

Sponsor

Durham VA Medical Center

Last update posted

Apr 15, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Durham VA Medical Center on 2024-04-15.