Status:
RECRUITING
The Diabetes Staging System in Patient Aligned Care Teams
Lead Sponsor:
Durham VA Medical Center
Conditions:
Diabetes Mellitus
Type 2 Diabetes
Eligibility:
All Genders
25-75 years
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 cotrans...
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 com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06142006
Start Date
September 1 2023
End Date
September 1 2025
Last Update
April 15 2024
Active Locations (1)
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1
Greenville VA Health Care Center, 401 Moye Blvd
Greenville, North Carolina, United States, 27834