The Diabetes Staging System in Patient Aligned Care Teams

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142006
• Other study ID #: 1746160
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: Durham VA Medical Center
• Contact: Nadya T Majette, MPH
• Phone: 252-830-2149
• Email: Nadya.Majette[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Other:
• Diabetes 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

Locations

Country	Name	City	State
United States	Greenville VA Health Care Center, 401 Moye Blvd	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Durham VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dar MS, Beg SA. TNM cancer staging: can it help develop a novel staging system for type 2 diabetes? Diabetes Metab Syndr Obes. 2018 Nov 28;11:845-853. doi: 10.2147/DMSO.S179963. eCollection 2018. — View Citation

Dar MS, Wanner C, Marx N, Ofstad AP, Mattheus M, Kaspers S, Beg SA. Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes. Diabetes Obes Metab. 2023 May;25(5):1372-1384. doi: 10.1111/dom.14989. Epub 2023 Mar 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SGLT2i and/or GLP-1 agonist use after DSS EHR template use	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.	Baseline and 6 months after DSS implementation
Secondary	Weight	Measured in pounds	Baseline and 6 months after DSS implementation
Secondary	Blood pressure	Measures systolic and diastolic blood pressure in mmHG	Baseline and 6 months after DSS implementation
Secondary	Hemoglobin A1C	Measures average blood sugars control over the past 3 months	Baseline and 6 months after DSS implementation
Secondary	GFR	Measures glomerular filtration rate	Baseline and 6 months after DSS implementation