RECRUITING

The Diabetes Staging System in Patient Aligned Care Teams

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Conditions

Diabetes MellitusType 2 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-09-01
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06142006

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.

Ages Eligible for Study:25 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * male or female
  2. * 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)
  3. * prior history of chronic kidney disease (GFR \<60, microalbumin creatinine/ratio \>30 mg/g - creatinine on 3 separate occasions)
  4. * age 25-75 years
  5. * BMI \>27
  6. * diagnosis of type 2 diabetes
  7. * hemoglobin A1C \>7.0%
  8. * agreeable to regular visits per study protocol
  9. * 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
  1. * age \>75,
  2. * A1C \<7%
  3. * GFR \<30
  4. * pregnant
  5. * breast feeding
  6. * prior history of pancreatitis will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
  7. * prior history of gastroparesis, dysphagia will lead to avoidance of GLP-1 agonist therapy but not SGLT2i
  8. * 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
  9. * 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
  10. * 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
  11. * type 1 diabetes
  12. * 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
  13. * prior history of urinary tract infections will lead to avoidance of SGLT2i but not GLP-1 agonist therapy
  14. * prior h/o recurrent yeast infections will lead to avoidance of SGLT2i but not GLP-1 agonist therapy
  15. * 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
  16. * active diabetic foot ulcers or osteomyelitis will lead to avoidance of SGLT2i but not GLP-1 agonist therapy
  17. * unwilling or unable to complete scheduled testing
  18. * any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study
  19. * organ transplantation or those on immunosuppressants
  20. * chronic anticoagulation
  21. * recent myocardial infarction, unstable angina, stroke, coronary artery bypass or transient ischemia attacks in the past 6 months
  22. * chronic prednisone use
  23. * deep vein thrombosis in past 6 months
  24. * active malignancy-unstable psychiatric condition including active or current suicidal ideation
  25. * Enrolled in another research study related to diet and/or physical activity

Contacts and Locations

Study Contact

Nadya T Majette, MPH
CONTACT
252-830-2149
Nadya.Majette@va.gov

Principal Investigator

Moahad S Dar, MD
PRINCIPAL_INVESTIGATOR
Department of Veterans Affair, Durham VAHCS

Study Locations (Sites)

Greenville VA Health Care Center, 401 Moye Blvd
Greenville, North Carolina, 27834
United States

Collaborators and Investigators

Sponsor: Durham VA Medical Center

  • Moahad S Dar, MD, PRINCIPAL_INVESTIGATOR, Department of Veterans Affair, Durham VAHCS

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 Registration Dates

Study Start Date2023-09-01
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus
  • Type 2 Diabetes