NCT06046560

Diabetes Remote Intervention to improVe Use of Evidence-based Medications

DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 27 Years – 79 Years
• Healthy volunteers: Accepted

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 diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months.

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 RA were randomly assigned to 1) simultaneous patient education and medication initiation "simultaneous" arm or 2) 2-months of education followed by medication initiation "education-first" arm. A multi-disciplinary team provided education and prescribed GDMT using a treatment algorithm. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months. Secondary objectives included the primary outcome by randomization arm, prescribed therapy by 2 months, and patients taking prescribed therapy.

Conditions

• Cardiovascular Diseases
• Diabetes

Interventions

Type	Name	Description
DRUG	SGLT2 inhibitor, GLP-1 RA	Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.
BEHAVIORAL	Education-First	For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.

Timeline

• Start date: 2021-03-22
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2023-09-21
• Last updated: 2024-10-23
• Results posted: 2024-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study