Diabetes Remote Intervention to improVe Use of Evidence-based Medications

Diabetes Clinical Trial

— DRIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06046560
• Other study ID #: 2020P003822
• Status: Completed
• Phase: Phase 4
• Start date: March 22, 2021
• Est. completion date: July 25, 2023

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body weight (kg)	Change in body weight (kg)	From 0-months (baseline) to 6-months following enrollment
Other	Change in body weight (%)	Change in body weight (%)	From 0-months (baseline) to 6-months following enrollment
Other	Change in laboratory measured HbA1c	Change in laboratory measured HbA1c	From 0-months (baseline) to 6-months following enrollment
Primary	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	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
Secondary	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
Secondary	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
Secondary	Short-form Patient Activation Measure (PAM)	Short-form Patient Activation Measure (PAM)	From 0-months (baseline) to 6-months following enrollment