Clinical trial NCT06046560: Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Official title: DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Diabetes
Keywords: Digital Health
Remote Care Delivery
Team-based Care Model
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2023-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 27
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: One group of patients, upon randomization, will immediately begin participation in a remote, pharmacist-driven clinic that will initiate and titrate medications according to a standardized medical algorithm. The comparator group will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time
timeFrame: Any time between 0-months (baseline) to 6-months following enrollment
Secondary outcomes:
measure: Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months
timeFrame: 2-months following enrollment
measure: Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months
timeFrame: At 6-months following enrollment
measure: Change in Short-form Patient Activation Measure (PAM)
timeFrame: From 0-months (baseline) to 6-months following enrollment
Other outcomes:
measure: Change in Body Weight (kg)
timeFrame: From 0-months (baseline) to 6-months following enrollment
measure: Change in Body Weight (%)
timeFrame: From 0-months (baseline) to 6-months following enrollment
measure: Change in Laboratory Measured HbA1c
timeFrame: From 0-months (baseline) to 6-months following enrollment
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Benjamin M Scirica, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blood AJ, Chang LS, Colling C, Stern G, Gabovitch D, Feldman G, Adan A, Waterman F, Durden E, Hamersky C, Noone J, Aronson SJ, Liberatore P, Gaziano TA, Matta LS, Plutzky J, Cannon CP, Wexler DJ, Scirica BM. Methods, rationale, and design for a remote pharmacist and navigator-driven disease management program to improve guideline-directed medical therapy in patients with type 2 diabetes at elevated cardiovascular and/or kidney risk. Prim Care Diabetes. 2024 Apr;18(2):202-209. doi: 10.1016/j.pcd.2024.01.005. Epub 2024 Feb 1.
citation: Blood AJ, Chang LS, Hassan S, Chasse J, Stern G, Gabovitch D, Zelle D, Colling C, Aronson SJ, Figueroa C, Collins E, Ruggiero R, Zacherle E, Noone J, Robar C, Plutzky J, Gaziano TA, Cannon CP, Wexler DJ, Scirica BM. Randomized Evaluation of a Remote Management Program to Improve Guideline-Directed Medical Therapy: The DRIVE Trial. Circulation. 2024 Jun 4;149(23):1802-1811. doi: 10.1161/CIRCULATIONAHA.124.069494. Epub 2024 Apr 7.