The Diabetes Staging System in Patient Aligned Care Teams (DSS)

April 12, 2024 updated by: Durham VA Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Greenville VA Health Care Center, 401 Moye Blvd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Eligible subjects within each PACT team will be identified retrospectively at baseline to by the study coordinator using inclusion/exclusion criteria noted below. There is no specific number of subjects that will be enrolled rather we will make a determination of % of Veterans with DM2 and CVD who are on SGLT2i/GLP-1 agonist at baseline and after 6 months of DSS use by the participating PACT teams. Veteran patients will not require consent because SGLT2i/GLP-1 agonist is standard of care in DM2 with CV disease patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SGLT2i and/or GLP-1 agonist use after DSS EHR template use
Time Frame: 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.
Baseline and 6 months after DSS implementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline and 6 months after DSS implementation
Measured in pounds
Baseline and 6 months after DSS implementation
Blood pressure
Time Frame: Baseline and 6 months after DSS implementation
Measures systolic and diastolic blood pressure in mmHG
Baseline and 6 months after DSS implementation
Hemoglobin A1C
Time Frame: Baseline and 6 months after DSS implementation
Measures average blood sugars control over the past 3 months
Baseline and 6 months after DSS implementation
GFR
Time Frame: Baseline and 6 months after DSS implementation
Measures glomerular filtration rate
Baseline and 6 months after DSS implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durham VA Medical Center

Investigators

  • Principal Investigator: Moahad S Dar, MD, Department of Veterans Affair, Durham VAHCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1746160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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