The Diabetes Staging System in Patient Aligned Care Teams

Description

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 Overview

Study Details

Study overview

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.

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 Diabetes Staging System in Patient Aligned Care Teams

Condition
Diabetes Mellitus
Intervention / Treatment

-

Contacts and Locations

Greenville

Greenville VA Health Care Center, 401 Moye Blvd, Greenville, North Carolina, United States, 27834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

25 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Durham VA Medical Center,

Moahad S Dar, MD, PRINCIPAL_INVESTIGATOR, Department of Veterans Affair, Durham VAHCS

Study Record Dates

2025-09-01