Diabetes Remote Intervention to improVe Use of Evidence-based Medications (DRIVE)

October 21, 2024 updated by: Benjamin M. Scirica, MD, Brigham and Women's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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

Description

Inclusion Criteria:

  1. Aged 27 - 79 years at the time of agreeing to participate in the program
  2. Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin)
  3. HbA1c 6.5-8.9%; AND
  4. 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
  5. Has seen a primary care provider within the Mass General Brigham network within the last year

Exclusion Criteria:

  1. Type 1 diabetes
  2. Currently or previously prescribed an SGLT2i or GLP1-RA
  3. Taking any short-acting insulin
  4. History of diabetic ketoacidosis
  5. History of hypoglycemia requiring hospitalization
  6. Frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose <70 mg/dL
  7. eGFR below 15 ml/min/m2
  8. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, OR
  9. Life expectancy less than 1 year or utilizing palliative care

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medication & Education-First
Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.
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.
Experimental: Education-First
Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time
Time Frame: Any time between 0-months (baseline) to 6-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1-RA at any time
Any time between 0-months (baseline) to 6-months following enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months
Time Frame: 2-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months
2-months following enrollment
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months
Time Frame: At 6-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months
At 6-months following enrollment
Change in Short-form Patient Activation Measure (PAM)
Time Frame: From 0-months (baseline) to 6-months following enrollment

Change in Short-form Patient Activation Measure (PAM)

The score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months).

0.0 - 1.0 (Disengaged & Overwhelmed)

1.1 - 2.0 (Becoming Aware But Still Struggling)

2.1 - 3.0 (Taking Action & Gaining Control)

3.1 - 4.0 (Maintaining Behaviors & Pushing Further)
From 0-months (baseline) to 6-months following enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight (kg)
Time Frame: From 0-months (baseline) to 6-months following enrollment
Change in body weight (kg)
From 0-months (baseline) to 6-months following enrollment
Change in Body Weight (%)
Time Frame: From 0-months (baseline) to 6-months following enrollment
Change in body weight (%)
From 0-months (baseline) to 6-months following enrollment
Change in Laboratory Measured HbA1c
Time Frame: From 0-months (baseline) to 6-months following enrollment
Change in laboratory measured HbA1c
From 0-months (baseline) to 6-months following enrollment

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Collaborators

Novo Nordisk A/S via Research Grant to Brigham and Women's Hospital

Investigators

  • Principal Investigator: Benjamin M Scirica, MD MPH, Brigham and Women's Hospital

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)

March 22, 2021

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P003822

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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