Status:
COMPLETED
Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Cardiovascular Diseases
Diabetes
Eligibility:
All Genders
27-79 years
Phase:
PHASE4
Brief Summary
A randomized remote, implementation trial in the Mass General Brigham network was performed on 200 patients with T2D at high CV or kidney risk. The study's primary objective was to create a remote dia...
Detailed Description
A randomized remote, implementation trial in the Mass General Brigham network performed on 200 patients with T2D at high CV or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP-1 R...
Eligibility Criteria
Inclusion
- Aged 27 - 79 years at the time of agreeing to participate in the program
- Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin)
- HbA1c 6.5-8.9%; AND
- At elevated cardiovascular and/or renal risk defined as any diagnosed ASCVD, estimated ASCVD risk \>10%, congestive heart failure, non-alcoholic fatty liver disease, estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2, albuminuria above 300mg/g; and those aged 60 years or older with at least two of: active tobacco use, dyslipidemia (LDL-c above 160 mg/dL or 4.1 mmol/L, non-HDL-C above 190 mg/dL or 4.9 mmol/L, triglycerides above 175 mg/dL,) hypertension (2 systolic blood pressure values above 130 mmHg and/or 2 diastolic blood pressure values above 90 mmHg within 12 months,) or BMI above 30
- Has seen a primary care provider within the Mass General Brigham network within the last year
Exclusion
- Type 1 diabetes
- Currently or previously prescribed an SGLT2i or GLP1-RA
- Taking any short-acting insulin
- History of diabetic ketoacidosis
- History of hypoglycemia requiring hospitalization
- Frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose \<70 mg/dL
- eGFR below 15 ml/min/m2
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, OR
- Life expectancy less than 1 year or utilizing palliative care
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06046560
Start Date
March 22 2021
End Date
July 25 2023
Last Update
October 23 2024
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115