Diabetes Remote Intervention to improVe Use of Evidence-based Medications

NCT06046560 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2020P003822
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Diabetes

Keywords

Digital Health; Remote Care Delivery; Team-based Care Model

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time

  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 Outcomes (3)

• 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

  At 6-months following enrollment

• Change in Short-form Patient Activation Measure (PAM)

  From 0-months (baseline) to 6-months following enrollment

Other Outcomes (3)

• Change in Body Weight (kg)

  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

  From 0-months (baseline) to 6-months following enrollment

Study Arms (2)

Medication & Education-First

ACTIVE COMPARATOR

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

Education-First

EXPERIMENTAL

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; Behavioral: Education-First

Interventions

SGLT2 inhibitor, GLP-1 RA DRUG

Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.

Education-First; Medication & Education-First

Education-First BEHAVIORAL

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.

Education-First

Eligibility Criteria

• Age: 27 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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.

  PMID: 38302335 BACKGROUND

• 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.

  PMID: 38583146 RESULT

• Chang LS, Hassan S, Chasse J, Stern G, Gabovitch D, Zelle D, Colling C, Crossen J, Aronson SJ, Oates M, Figueroa C, Collins E, Ruggiero R, Plutzky J, Gaziano TA, Cannon CP, Wexler DJ, Scirica BM, Blood AJ. Safety of a remote disease management program to improve sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists prescribing in type 2 diabetes with elevated cardiovascular or kidney risk. Am Heart J. 2026 Jan 27:107359. doi: 10.1016/j.ahj.2026.107359. Online ahead of print.

  PMID: 41610902 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Limitations and Caveats

The PAM Survey (Secondary Outcome) completion rate experienced low participant engagement: 90 participants missing baseline, 171 missing 60 day, and 159 missing 180 day.

Results Point of Contact

• Title: Alexander Blood, MD
• Organization: Mass General Brigham

ablood3@mgb.org

617-732-7144

Study Officials

• Benjamin M Scirica, MD MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 21, 2023
• Study Start: March 22, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Locations

US (1)