Cardiovascular DiseasesPhase 4DRIVENCT06046560
Diabetes Remote Intervention to improVe Use of Evidence-based Medications
A Phase 4 study testing SGLT2 inhibitor, GLP-1 RA and Education-First in people with Cardiovascular Diseases and Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 27 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes
- What is being tested?
- SGLT2 inhibitor, GLP-1 RA and Education-First
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 25 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Diabetes
- Being tested
- SGLT2 inhibitor, GLP-1 RA, Education-First
- Keywords
- Digital Health, Remote Care Delivery, Team-based Care Model
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitor, GLP-1 RADrug
Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.
Education-FirstBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: SGLT2 inhibitor, GLP-1 RA; Behavioral: Education-First |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months
Measured: 2-months following enrollment
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
Measured: 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)
Measured: From 0-months (baseline) to 6-months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 Mar 2021
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Benjamin M. Scirica, MD, Brigham and Women's Hospital
- Investigators
- Benjamin M Scirica, MD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046560
- Sponsor's protocol ID
- 2020P003822
- Acronym
- DRIVE
- Status last verified
- Oct 2024
- First submitted
- 31 Aug 2023
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38302335Blood 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.
PubMed 38583146Chang 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.
PubMed 41610902
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications
- ClinicalTrials.gov ID
- NCT06046560
- Acronym / sponsor ID
- DRIVE / 2020P003822
- Conditions
- Cardiovascular Diseases, Diabetes
- Keywords
- Digital Health, Remote Care Delivery, Team-based Care Model
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medication & Education-First | Active comparator | Drug: SGLT2 inhibitor, GLP-1 RAPatient 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 | Drug: SGLT2 inhibitor, GLP-1 RA, Behavioral: Education-FirstPatient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. |
Who may qualify
- Ages
- 27 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitor, GLP-1 RAImmediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. | Drug | Education-First, Medication & Education-First |
| Education-FirstFor 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. | Behavioural | Education-First |
Primary outcome
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time
Time frame: Any time between 0-months (baseline) to 6-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1-RA at any time
3 secondary outcomes
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months
Time frame: 2-months following enrollment
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months
Time frame: At 6-months following enrollment
Change in Short-form Patient Activation Measure (PAM)
Time frame: From 0-months (baseline) to 6-months following enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38302335Blood 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.
- Results publication: PubMed 38583146Blood 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.
- Derived from this study: PubMed 41610902Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Scirica, MD MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT2 inhibitor, GLP-1 RA and Education-First in people with Cardiovascular Diseases and Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time (time frame: Any time between 0-months (baseline) to 6-months following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046560, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.