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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months | 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 |
| 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 (%) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin M Scirica, MD MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38302335 | Background | 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. | |
| 38583146 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Any time between 0-months (baseline) to 6-months following enrollment |
|
Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later.
Adverse events were only assessed for participants who started a study medication.
Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug.
The SAE definition also included urgent care visits.
Systematic assessments were performed through phone call questionaires given to participants.
Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Genital Mycotic Infection | Infections and infestations | Systematic Assessment |
The PAM Survey (Secondary Outcome) completion rate experienced low participant engagement: 90 participants missing baseline, 171 missing 60 day, and 159 missing 180 day.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Blood, MD | Mass General Brigham | 617-732-7144 | ablood3@mgb.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 9, 2021 | Sep 17, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2023 | Sep 17, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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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.
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| 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. |
|
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) | 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 |
| 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 |
| Result |
| 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. |
| 41610902 | Derived | 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 Jun;296:107359. doi: 10.1016/j.ahj.2026.107359. Epub 2026 Jan 27. |
| BG001 | 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. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
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.
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.
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.
|
|
| Secondary | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months | Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months | Posted | Count of Participants | Participants | 2-months following enrollment |
|
|
|
| Secondary | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months | Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months | Posted | Count of Participants | Participants | At 6-months following enrollment |
|
|
|
| Secondary | Change in Short-form Patient Activation Measure (PAM) | 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) | Posted | Mean | Standard Deviation | score on a scale | From 0-months (baseline) to 6-months following enrollment |
|
|
|
| Other Pre-specified | Change in Body Weight (kg) | Change in body weight (kg) | Posted | Mean | Standard Deviation | kg | From 0-months (baseline) to 6-months following enrollment |
|
|
|
| Other Pre-specified | Change in Body Weight (%) | Change in body weight (%) | Posted | Mean | Standard Deviation | % weight change | From 0-months (baseline) to 6-months following enrollment |
|
|
|
| Other Pre-specified | Change in Laboratory Measured HbA1c | Change in laboratory measured HbA1c | Posted | Mean | Standard Deviation | % change in HbA1c | From 0-months (baseline) to 6-months following enrollment |
|
|
|
| 1 |
| 69 |
| 2 |
| 69 |
| 36 |
| 69 |
| EG001 | 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. 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. 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. | 0 | 37 | 0 | 37 | 14 | 37 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Hypovolemia | Cardiac disorders | Systematic Assessment | Symptoms consistent with possible volume depletion |
|
| Hypoglycemia | Endocrine disorders | Systematic Assessment | Glucose <70 mg/dL |
|
| Severe hypoglycemia | Endocrine disorders | Systematic Assessment | Glucose <70 mg/dL and requiring assistance from another person |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
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| D045505 | Physiological Effects of Drugs |