The Diabetes Staging System in Patient Aligned Care Teams
- Conditions
- Type 2 DiabetesDiabetes Mellitus
- Registration Number
- NCT06142006
- Lead Sponsor
- Durham VA Medical Center
- 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.
- Detailed Description
The Diabetes Staging System (DSS) is a novel type 2 diabetes (DM2) staging system patterned after Tumor Node Metastasis (TNM) cancer staging that uses the number of macrovascular and microvascular complications and most recent A1C and glomerular filtration rate (GFR) to determine DSS stage which reflects disease severity. The DSS stage is then linked to specific evidence-based clinical interventions that decrease morbidity and mortality. One of the most important clinical interventions of the DSS is recommending a SGLT2i/GLP-1 agonist in DM2 patients with CVD which helps address the inequity of low overall SGLT2i/GLP-1 use. The DSS has been adapted into a CPRS-DSS template available to all PACT providers within the Durham VA system which could address the racial differences in SGLT2i/GLP-1 agonist use. DSS offers a systematic approach to DM2 care (Stage DM2 -determine medical therapy based on DM2 stage) that has the potential to address inequities related to SGLT2i/GLP-1 overall use and racial differences in use. Primary Care Aligned Teams (PACT) are best positioned to use the DSS because they treat the vast majority of Veteran DM2 patients. This pilot proposal will seek to address inequities in SGLT2i/GLP-1 agonist use within in the VA by examining the feasibility and acceptability of the DSS among 12 different PACT teams within the Durham VA Medical System by measuring its ability to increase SGLT2i/GLP-1 agonist after 6 months of DSS implementation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SGLT2i and/or GLP-1 agonist use after DSS EHR template use Baseline and 6 months after DSS implementation Percentage of Caucasian and African American DM2 Veteran patients with CVD who are on SGLT2i and/or GLP-1 agonist at baseline and 6 months after provider DSS EHR template use.
- Secondary Outcome Measures
Name Time Method Weight Baseline and 6 months after DSS implementation Measured in pounds
Blood pressure Baseline and 6 months after DSS implementation Measures systolic and diastolic blood pressure in mmHG
Hemoglobin A1C Baseline and 6 months after DSS implementation Measures average blood sugars control over the past 3 months
GFR Baseline and 6 months after DSS implementation Measures glomerular filtration rate
Trial Locations
- Locations (1)
Greenville VA Health Care Center, 401 Moye Blvd
🇺🇸Greenville, North Carolina, United States