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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

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
Nadya T Majette, MPH252-830-2149Nadya.Majette@va.gov

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