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DRIVE

CompletedPhase 4Results posted

Diabetes Remote Intervention to improVe Use of Evidence-based Medications

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

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

-

Actual enrollment

200

Study population

Cardiovascular disease

Eligibility highlights

BMI ≥30HbA1c 6.5-8.9%eGFR ≤60

Primary endpoint

Prescriptions of SGLT2i or GLP1-RA at Any Time

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06046560
Org study ID2020P003822

Timeline

Milestones

Study start2021-03-22actual
Primary completion2023-07-25actual
Study completion2023-07-25actual
Study first posted2023-09-21actual
Last update posted2024-10-23actual
Results first posted2024-10-23actual

Assets

Investigational agents

Who this study enrolls

Cardiovascular disease

Who can enroll

Minimum age27 Years
Maximum age79 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
4
Weight & body composition
2
Glycemic / diabetes
1

Weight & body composition

2 endpoints
Other/protocol endpoint

Change in Body Weight (kg)

Time frame:From 0-months (baseline) to 6-months following enrollment

change from baseline, improvement

Other/protocol endpoint

Change in Body Weight (%)

Time frame:From 0-months (baseline) to 6-months following enrollment

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Other/protocol endpoint

Change in Laboratory Measured HbA1c

Time frame:From 0-months (baseline) to 6-months following enrollment

change from baseline, improvement

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

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

event count, event

Secondary/protocol endpoint/low confidence

Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months

Time frame:2-months following enrollment

event count, event

Secondary/protocol endpoint/low confidence

Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months

Time frame:At 6-months following enrollment

event count, event

Secondary/protocol endpoint/low confidence

Change in Short-form Patient Activation Measure (PAM)

Time frame:From 0-months (baseline) to 6-months following enrollment

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.