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

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: Cardiovascular Diseases; Diabetes
• Intervention / Treatment: Drug: SGLT2 inhibitor, GLP-1 RA; Behavioral: Education-First

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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
Proportion of patients with prescriptions of SGLT2i or GLP1-RA at any time	Proportion of patients with prescriptions of SGLT2i or GLP1-RA at any time	From 0-months (baseline) to 6-months following enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with prescriptions of SGLT2i or GLP1-RA by randomization arm	Proportion of patients with prescriptions of SGLT2i or GLP1-RA by randomization arm	From 0-months (baseline) to 6-months following enrollment
Proportion of patients with prescriptions of SGLT2i or GLP1-RA at 2-months	Proportion of patients with prescriptions of SGLT2i or GLP1 RA at 2-months	2-months following enrollment
Proportion of patients with prescriptions of SGLT2i or GLP1-RA at 6-months	Proportion of patients with prescriptions of SGLT2i or GLP1-RA at 6-months	6-months following enrollment
Short-form Patient Activation Measure (PAM)	Short-form Patient Activation Measure (PAM)	From 0-months (baseline) to 6-months following enrollment

Other Outcome Measures

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

Collaborators and Investigators

• 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

Study record dates

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): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Digital Health; Remote Care Delivery; Team-based Care Model
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors
• 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