RecruitingNCT06142006

The Diabetes Staging System in Patient Aligned Care Teams

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

Sponsor

Durham VA Medical Center

Enrollment

120 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus Type 2 Diabetes

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

Min Age: 25 YearsMax Age: 75 Years

Inclusion Criteria9

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 Criteria25

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

Interventions

OTHERDiabetes 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