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The Diabetes Staging System in Patient Aligned Care Teams
RECRUITINGSponsored by Durham VA Medical Center
Actively Recruiting
SponsorDurham VA Medical Center
Started2023-09-01
Est. completion2024-09-01
Eligibility
Age25 Years – 75 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06142006
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.
Eligibility
Age: 25 Years – 75 YearsHealthy 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
Conditions3
DiabetesDiabetes MellitusType 2 Diabetes
Locations1 site
Greenville VA Health Care Center, 401 Moye Blvd
Greenville, North Carolina, 27834
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Actively Recruiting
SponsorDurham VA Medical Center
Started2023-09-01
Est. completion2024-09-01
Eligibility
Age25 Years – 75 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06142006